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FIRST LADY HILLARY RODHAM CLINTON
PEDIATRIC AIDS FOUNDATION "KIDS FOR KIDS"
NEW YORK, NEW YORK
SEPTEMBER 25, 1994
INTRODUCTION
As I travelled the country during the past year visiting
hospitals and clinics, nothing touched me more than the sight of
too many brave children and families struggling to cope with HIV
infection and AIDS. I have seen children who have spent most of
their short lives in hospitals -- keeping up their courage
through one more blood test, one more procedure. And I have been
awed by their refusal to give up. By their hope.
No one has inspired me more with the depth of her own hope
and courage than Elizabeth Glaser. Day in and day out --
confronting personal tragedy and her own struggle with AIDS --
she carries on, fights back, and gives new hope to so many
others.
Today, Elizabeth and the Pediatric AIDS Foundation, Liz
Tilberis and Harper's Bazaar magazine, Donna Karan, Chris and Pat
Riley and all of you are giving hope to children living with
AIDS, and giving the gift of health to children who will be
spared from the disease because of successful prevention and
research. What a wonderful way to celebrate our power to have
hope and to give hope -- even as we face this terrible disease.
STATISTICS ON PEDIATRIC AIDS
HIV infection. In the United States today, HIV infects
1,300 to 2,000 newborns each year and has become one of the
top 10 leading causes of death of young children. As many
as 10,000 to 20,000 children in the United States may be
infected with HIV.
Worldwide the numbers are even more staggering. In 1990
alone, 1 million children acquired HIV from their infected
mother before or during birth. The World Health
Organization predicts that by the year 2000, there will be
10 million children infected with HIV worldwide.
AIDS cases. Through June of this year, over 5,700 AIDS
cases have been reported in the U.S. among children less
than 13 years of age. of these, more than 3,000 children
have already died.
And the number of children with AIDS is increasing -- 39% of
all AIDS cases among children in the U.S. have been reported
in the last 2 1/2 years alone.
Orphaned children. In addition to the children who are
infected with HIV, many more are affected by HIV and AIDS.
Researchers estimate that 20,000 children in the United
States have already been orphaned because a parent has died
from HIV infection. This number is expected to reach
125,000 to 150,000 by the end of this decade. Across the
world, by the end of the 1990s, 10 to 15 million children
will be orphaned by the death of one of their parents
through AIDS.
WHAT IS BEING DONE
These terribly sad statistics can overwhelm us. But we must
not forget that there are many good and courageous people working
tirelessly. The Clinton Administration is committed to investing
in this work on prevention, treatment, and research.
Research. Funding for pediatric AIDS research at the
National Institutes for Health has increased by over 25%
under the Clinton Administration's budgets.
A recent NIH study that some of you may know about tells us
that research produces results. The study has shown that
when AZT is administered to HIV infected pregnant women, the
rate of transmission to their babies drops significantly --
from one chance in 4 of infection to about one in 12. One
in 12 is still tragic. But progress is being made, and this
news alone tells us that our investment in AIDS research is
worth it.
Prevention and treatment. Yet good research is only half
the battle. We must also continue to encourage prevention
and to make sure that those children and their families who
do have HIV disease get treatment and support services.
The President has supported a 30% increase in funding for
Title IV of the Ryan White CARE Act -- which gives grants
for community-based, family-centered care programs. And
last year the Centers for Disease Control began a major new
prevention initiative targeted at adolescents and young
adults.
ELIZABETH GLASER AND THE PEDIATRIC AIDS FOUNDATION
Nobody has fought harder and done more in the fight against
pediatric AIDS than Elizabeth Glaser. And nobody has fought with
such dignity and courage. When Elizabeth discovered that she had
contracted the HIV virus from a contaminated blood transfusion
after the birth of her daughter Ariel, she could have given up.
When she discovered that she had unknowingly passed the virus to
Ariel during breast-feeding and then to her son born 3 years
later, she could have given up. And when Ariel died of HIV
2
infection at the age of 7, Elizabeth could have given up. But
instead of giving in and giving up, Elizabeth channeled her
energy and passion into the fight against pediatric AIDS.
When Elizabeth helped found the Pediatric AIDS Foundation in
1988, there was no pediatric AIDS research agenda. Since
then, the Foundation has raised and invested $13 million in
research grants and scholar awards. It has sponsored unique
collaborations among government, drug companies, and private
research institutions and universities. Its Ariel Project
has brought key researchers and clinicians together to find
a way to block transmission from an infected mother to her
newborn child.
Elizabeth has had tremendous success in mobilizing private
support and getting Republicans and Democrats to put aside
partisan bickering and work together against AIDS. She has
done this in part because she reminds us that everyone is at
risk -- wealthy or poor, black or white. But, more
importantly, she has done this because of her enormous
tenacity, compassion and intelligence.
CONCLUSION
The fight against pediatric AIDS is not futile. We can
improve access to treatment, especially in traditionally
underserved African-American and Hispanic communities. We can
reach out to our children and teach them about prevention. We
can fund research -- to find ways to block transmission, to test
new drugs that will lengthen and improve the quality of peoples'
lives and, finally, to find a cure for AIDS.
The battle is being fought every day -- by advocates like
Elizabeth Glaser and the Pediatric AIDS Foundation, by
researchers and doctors, by mothers and fathers, and by so many
-- by too many -- remarkably brave and strong children. This is
a battle we can win by maintaining hope and working hard. As
Elizabeth herself has said, everyone with AIDS is somebody's
child. This is a battle we must win for all of our children.
3
AIDS
The Pediatric AIDS Foundation
Second Annual
"KIDS FOR KIDS"
DATE:
Sunday, September 25, 1994
TIME:
3:00 to 6:00 pm
LOCATION:
Industria Superstudio, 775 Washington Street
CHAIRS:
Elizabeth Glaser, Donna Karan, Chris and Pat Riley
and Liz Tilberis
Harper's Bazaar magazine and the Pediatric AIDS Foundation are joining forces to bring an extraordinary event
to New York City this fall. On Sunday, September 25, 1994, they will be hosting a unique carnival and street fair
to benefit the Pediatric AIDS Foundation, an organization co-founded by Elizabeth Glaser, Susan DeLaurentis and
Susie Zeegen to fund research designed to confront medical problems unique to children with AIDS. Some of the
most talented and exciting artists, designers, sports figures, photographers and celebrities will be donating their time
and effort to create an unforgettable afternoon of activities and games for families and children of all ages.
Activities:
STREET FAIR
The street in front of Industria will be closed and tented and a fair consisting of activities and carnival games for
children of all ages will be created. Designers, celebrities and other "heroes" will man the booths with such
attractions as a dunk tank, hi striker, wheel of fortune, peg toss, face painting and other exciting games. Jugglers,
clowns, and other performance artists will wander throughout the carnival space entertaining families. Some of last
year's heroes who worked the booths included Michael Bolton, Tom Brokaw, Michael Douglas, Daryl Hannah,
Dustin Hoffman, Ron Howard, Spike Lee, Christopher Reeve, Brooke Shields and Paula Zahn.
SPORTS - Captains - Pat and Chris Riley
One-half of the street fair will be devoted to sports games including football toss, basketball, miniature golf,
quarterback challenge, baseball batting and slapshot hockey. Pat and Chris Riley are recruiting sports heroes of
past and present to man the booths and pose for pictures and sign autographs. Last year's sport stars included the
entire New York Knicks team, Tony Campbell, Donna De Varona, Joe Frazier, Rod Gilbert, Keith
Hernandez, Denis Potvin and JoJo Starbuck.
HEROES - Captain - Diane Von Furstenberg
Diane Von Furstenberg will spearhead the effort to enlist celebrity participation. The street fair will be overflowing
with a stellar cast of celebrity heroes and their families.
PHOTOGRAPHY - Captain - Fabrizio Ferri
Fabrizio Ferri is organizing world famous photographers to take family portraits of guests in a specially designed
studio at Industria. Families will take home a polaroid shot but will receive by mail soon after a beautifully
developed print taken by one of the prominent photographers. Mary Ellen Mark, Francesco Scavullo and Bert
Stern were among the photographers who participated last year.
ART - Co-Captains - Jennifer Bartlett and Robert Rosenblum
An art studio will be set up inside Industria where children will join with distinguished New York artists recruited
by Jennifer Bartlett and art historian Robert Rosenblum to paint giant murals to be donated to the pediatrics wards
of hospitals in the city. Paper will also be laid out on tables enabling children to create their own smaller drawings.
Last year's roster of artists included Francesco Clemente, Red Grooms, Roy Lichtenstein, Brice Marden, Kenny
Scharf and Frank Stella.
FOOD - Captain - Brian McNally
The upper level of Industria will house a large food court, where some of New York's best restaurants will provide
a sampling of their finest cuisine. Restaurant owner Brian McNally will be organizing the restaurants, all of which
will be serving food that will be particularly appealing to children. "44," Cafe Luxembourg, Coco Pazzo, Le
Madri, Odeon and Tribeca Grill were among the many restaurants who participated last year.
PRIZES - John and Dolores Eyler
Wonderful prizes for children of all ages will be donated by leading toy companies for winners of various games.
With the world's most beloved toy store at the cornerstone of this effort, F.A.O. Schwarz President and CEO John
Eyler and his wife Dolores will ensure that no child leaves empty handed. Toys will also be donated to pediatric
wards of New York area hospitals.
MODELS - Captain - Sara Foley Anderson
Model editor Sara Foley Anderson will organize the participation of the world's most unforgettable models in
support of the Pediatric AIDS Foundation.
DANCE
The dance studio will be rockin' as children will have the opportunity to participate in a fun dance workshop/disco
led by an array of professional dance talents.
RAFFLE
"KIDS FOR KIDS" will feature an irresistible selection of prestige raffle items. Families will have the chance to
purchase raffle tickets prior to and during the event.
For further information, please contact Jeaneane Judelson, Pediatric AIDS Foundation - (212) 545-2435, fax (212)
545-2468.
FOR IMMEDIATE RELEASE
Contact:
Press:
Susan Magrino/Allyn Magrino
Susan Magrino Agency
(212) 744-2004
Pediatric AIDS Foundation:
Jeaneane Judelson
(212) 545-2435
HILLARY RODHAM CLINTON TO SERVE AS HONORARY CHAIR AND ATTEND
PEDIATRIC AIDS FOUNDATION SECOND ANNUAL "KIDS FOR KIDS"
CELEBRITY STREET FAIR AND CARNIVAL
- Sunday, September 25th, 1994 --
New York, NY August (DATE), 1994 -- First Lady Hillary Rodham Clinton will serve as
honorary chair of the Pediatric AIDS Foundation's second annual "KIDS FOR KIDS" carnival in
New York City at Industria Superstudio, on Sunday, September 25, 1994. Mrs. Clinton plans to
attend the event and man one of the carnival booths herself. Harper's BAZAAR, Hearst Magazine's
fashion monthly will underwrite the event and Liz Tilberis, editor-in-chief of Harper's Bazaar, will
co-chair the event with Elizabeth Glaser, Donna Karan and Chris and Pat Riley.
The Pediatric AIDS Foundation KIDS FOR KIDS, a festive street fair and carnival which will
raise money for pediatric AIDS research, promises to be an extraordinary event bringing together a
stellar cast of artists, designers, sports figures, photographers and celebrities, all whom will be
donating their time and effort to this worthy cause. For the event, the street in front of Industria will
be transformed into a whimsical cornucopia of carnival games and special activities.
Notable celebrities, news broadcasters and designers, organized by "Hero" Captain Diane
Von Furstenberg, including Michael Bolton, Tom Brokaw, Katie Couric, Diane Sawyer, Ethan
Hawke, Mike Meyers, Phil Donahue, Marlo Thomas, Todd Oldham, Ralph Lauren and Miss
America 1995, will become "heroes" for the day, running the booths with such attractions as dunk
tanks, hi striker, wheel of fortune, peg toss, face painting and other exciting games. Jugglers,
clowns, and other performance artists will also entertain, engaging participants and passerbys alike.
Sara Foley Anderson, Harper's BAZAAR Model Editor, has enlisted some of the most sought after
fashion models in the world including Veronica Webb, Natane, Carla Bruni, Elle MacPherson and
many more. They will lend a hand at the games booths and sign autographs.
In addition to a carnival setting, the Industria environment will offer a sporting format,
highlighted by the attendance of the New York Knicks. Pat and Chris Riley will organize sports
games including baseball batting, miniature golf, basketball, football toss and slapshot hockey. The
sports area will also feature a special interactive sports exhibit. In addition to the New York Knicks
team, the sports line-up includes Mickey Mantle, Red Holtzman, Keith Hernandez, Rod Gilbert,
Jarrod Bunch and many other athletes. Family portraits will be taken by some of the most
internationally recognized photographers such as Patrick Demarchelier, Arthur Elgort and Fabrizio
Ferri and Jeanne Moutoussamy-Ashe, while children will be encouraged to join some of New
York's most distinguished artists in the Art Room, organized by Jennifer Bartlett and Robert
Rosenblum. Noted artists including Roy Lichtenstein, Red Grooms, Frank Stella, Kenny Scharf,
Brice Marden, Chuck Close and others will paint side-by-side with children to create unique murals
to be donated to pediatric AIDS wards in city hospitals.
Cowboys and cowgirls from Denim & Diamonds will lead a country-western jamboree as
they teach the kids to line dance and two-step in the dance room. A food court, organized by 44 at
the Royalton's Brian McNally will take over the upper level of Industria and feature a variety of
specialties donated by such acclaimed New York restaurants as Arcadia, Mesa Grill and Matthew's.
The restaurants will also offer a sampling of delicious dishes made especially with children in mind.
After playing at the carnival booths, children will be able to choose from a selection of prizes donated
by leading toy manufacturers, gathered by Prize Captains John and Dolores Eyler of F.A.O
Schwarz. All additional prizes will be donated to children with HIV/AIDS. United Airlines is the
official airline of the Pediatric AIDS Foundation.
The Pediatric AIDS Foundation was co-founded by Elizabeth Glaser, Susan DeLaurentis
and Susie Zeegen in 1988 to fund basic bio-medical pediatric AIDS research. As the leading national
organization confronting medical problems unique to children infected with HIV/AIDS, the Pediatric
AIDS Foundation offers hope to children living with this disease. "The extraordinary support from
Harper's BAZAAR through time, energy and financial commitment means so much to me, and to
millions of others. Harper's BAZAAR is helping to bring hope not only to my family, but to so
many children and families living with HIV/AIDS," said Elizabeth Glaser, Co-founder. Since it's
inception, the Foundation has raised over $25 million to fund research, as well as their Emergency
Assistance, Parent Education, and Student Intern Programs. Says Harper's BAZAAR editor-in-chief
Liz Tilberis, "With a disease that will account for more years of productive lives lost before the age
of 65 than all forms of cancer combined, the need for research is crucial. Harper's BAZAAR is truly
proud to sponsor such a talented team effort to raise the resources necessary to pushing critical
research forward."
Under the keen editorial direction of Ms. Tilberis, Harper's BAZAAR has received
widespread praise since its relaunch in September, 1992. Harper's BAZAAR touches the lives and
influences the decisions of millions of women in the United States and overseas. The magazine is
published in Great Britain (as Harper's & Queen) and through Hearst Magazines International, nine
other editions of the magazine are published in Europe, Asia and Latin America.
Pediatric
AIDS
Foundation
UPDATE: SPRING 1994
This is a special Update. The foundation has been in existence for over five years, and we want to share
some of our accomplishments with you. We also want to introduce you to Art Ammann. He is PAF's
Director of Research and heads our Scientific Advisory Board. We couldn't do what we do without him.
Art's credentials are impressive-- at the University of California he was Director of the Clinical Research
Center and Pediatric Immunology. At Genentech he was Director of Clinical Research, and was one of the
first doctors to identify AIDS in children. These are only to be topped by knowing him and working with
him in person. We asked Art to say a few words in the Update about what PAF is accomplishing from his
point of view. Again, we thank all of you for your continued support.
susan
Elizabeth Elizabeth Glaser
Ausie
Susan DeLaurentis
Susie Zeegen
This February we reached an important time in the brief history of the Pediatric AIDS Foundation. After
five years of supporting research it was time to reflect and examine. We invited a special group of indi-
viduals to our 10th Think Tank entitled "PAF: A Vision for Our Future." These were individuals we could
trust to be critical, analytical and imaginative. Their task was to review our progress and programs. It
was a time when all aspects of what the foundation does was discussed.
Their analysis and recommendations were clear. The foundation has had an influence beyond its size.
Our ability to remain focused is part of the success. The other part is the personal interest of the
Co-founders and staff in the research, the scientists, the Think Tanks and the Workshops. The Pediatric
AIDS Foundation is not just supporting research, it is intent on finding solutions to critical unanswered
questions. PAF's ability to work closely with advisors and researchers, to develop cooperative research
and to remain focused is unique in the scientific community.
The challenge for the future is to stay focused. Future research priorities were carefully ordered. A call
for continued support of basic investigator initiated research was made. The need for a highly visible
Pediatric AIDS Foundation Scholar Program was emphasized to attract and retain the brightest and most
innovative young researchers in pediatric AIDS. All our reviewers felt that support for targeted, directed
research projects, like the Ariel Project, was essential. The impact of the foundation over the past five
years has been dramatic. We look forward to the future with excitement and anticipation as we search
for answers.
Most sincerely,
Art Ammann, M.D.
Director of Research
Research produces results. .the recent results of the NIH study 076 revealed that when AZT
is administered to HIV infected pregnant women, the rate of transmission to their newborns
drops significantly. These results will have an impact on the pediatric and adult communities.
But many questions remain -- Why do some newborns still become infected? How do we make
treatment available to all HIV infected individuals? How do we halt the disease progression in
those already infected? Research must continue to provide solutions to remaining problems.
Warner Bros. sponsored one of New York's hottest events to benefit PAF: the opening of
their flagship Warner Bros. Studio Store. Warner Bros. helped PAF raise over $150,000 -
through ticket sales and the receipts from all merchandise purchased on opening night - and
helped raise awareness with an event that attracted great media attention.
As part of their 20th anniversary celebration, PEOPLE Magazine has kicked off an exciting
year-long charity campaign, entitled PEOPLE First, of which PAF is honored to be one of 3
charity beneficiaries. PEOPLE First is an extension of PEOPLE Magazine's efforts to educate as
well as entertain its readers, and will be helping PAF in a variety of ways.
A creative and caring project is the Kids + Kids = Kids Club, a group of 6 year old school
friends who, wanting to reach out and help other kids, got together to work on crafts which
they sold during the holiday season. donating $300 in proceeds to PAF.
We also want to share with you some of what PAF has
accomplished in its first five years as a result of your support.
Research Grants and Scholar Awards: PAF has funded 171 researchers around the
country working on investigator initiated research projects that are in the areas our
Think Tanks have determined to be critical to children with HIV infection. To date we
have funded $13 million in research grants and scholar awards.
Ariel Project: We have led the way in cooperative, directed research with our 3 year
ground breaking Ariel Project for the Prevention of HIV Transmission from Mother to
Infant. This project. with an annual $3 million commitment, has the potential to create
a world in which no additional children will be born with HIV.
Parent Education Program: 70,000 units of this program. "HIV/AIDS: A Challenge to
Us All," consisting of 2 videos and a guide book, have been distributed in English or
Spanish, without charge. to PTAs, school systems, educational organizations and
religious groups nationwide. This program, for parents of preschool and elementary
age children, was generously underwritten by the Sega Charitable Trust.
Emergency Assistance Grants: Since this program's inception, PAF has funded 268
grants (totaling over $1 million) to help hospitals and health care facilities address
unmet emergency needs for their pediatric AIDS patients, such as transportation, child
care, medical equipment and meal vouchers.
Student Intern Awards: To encourage young people to enter the field of pediatric AIDS.
this program allows students to spend up to 8 weeks per year working with clinicians
and researchers known for their work in pediatric AIDS. PAF has funded 102 Student
Interns in 16 states.
Think Tanks and Workshops: PAF has held 10 Think Tanks, 6 One Day Workshops
and 2 National Pediatric Research Meetings providing a basis for unique collaborations
among members of government. drug companies, private research institutions and
universities. These meetings focus on specific issues affecting children with HIV/AIDS.
The Pediatric AIDS Foundation's ability to speak out on many issues surrounding HIV
has helped to educate thousands of Americans about how the virus is and is not
transmitted, that AIDS is a preventable disease, and that people infected with this virus
need and deserve support and compassion.
Printing courtesy of Wolfer Printing
Design courtesy of Parkin Design
Folding courtesy of Roger's Bindery
PAF's phone number is (310) 395-9051. To make a credit card donation call 1-800-488-5000.
Rediatric Foundation
Hope for Children with AIDS
Pediatric AIDS Foundation
1311 Colorado Avenue
Non-Profit Org.
Santa Monica. California 90404
Postage Paid
Santa Monica, CA
Permit Number 483
ADDRESS CORRECTION REQUESTED
Pediatric AIDS Foundation
Programs
Think Tanks and Research Grants
When the Pediatric AIDS Foundation (PAF) was founded in 1988, there was not a
pediatric AIDS research agenda. From the beginning, the foundation knew things
had to be done quickly and innovatively. The primary goal of PAF became to
identify this agenda, establish priorities and fund research. Since its inception, PAF
has sponsored nine Think Tanks, bringing together not only the brightest minds on
the cutting edge of pediatric AIDS research, but creative minds from other
disciplines as well. Doctors from the NIH, the CDC and private industry participate
alongside researchers from academia. Think Tank topics have included basic
pediatric research priorities, growth and nutrition, opportunistic infections, mucosal
immunity and maternal-fetal transmission. The conclusions are used to develop
PAF's research priorities which are then funded through our grant awards program.
Information of our pediatric agenda is also distributed to applicable government
agencies and legislators for action on the federal level.
PAF's Think Tanks and research grants have a direct relationship. Our funding
cycles are determined by the outcome of each Think Tank. First, an area of pediatric
AIDS research which has critical, unanswered questions is chosen. Then, key people
in that area are invited to spend a weekend at our Think Tank, sharing ideas and
thinking creatively of ways to find answers. The group prioritizes the steps to be
taken. Form this, an RFP (Request for Proposal) is developed and sent to researchers
around the world. Scientists then submit grant proposals which are reviewed by
PAF's scientific committee. The proposals are scored on scientific merit, and
funding is awarded based on scores, the goals of the foundation and the amount of
money PAF has available.
I write to extend my gratitude for one of the most invigorating scientific meetings
I have ever attended. The level of interchange was galvanizing. Your insistence
on a multi disciplinary approach led to a spontaneity and creativity which I have
seldom encountered. I hope that you will continue to recruit the best scientific
minds, many of whom are not presently investigating pediatric AIDS. If you can
convince these investigators to lend a portion of their talents to the problems of
pediatric AIDS, then you will win. I believe that you are on the verge of seeing a
logarithmic expansion of results. Science can indeed bring hope.
-Margaret Hostetter, M.D., Associate Professor of
Pediatrics and Microbiology, University of Minnesota
For additional information, or a complete list of research grants
which have been awarded, please contact PAF.
1/94
The Ariel Project for the Prevention
of HIV Transmission
from Mother to Infant
In February 1992, a Think Tank was held to define priorities for the prevention
of HIV transmission from mother to infant since virtually all new cases of
pediatric AIDS are from an infected mother passing the virus to her newborn.
Out of this, The Ariel Project for the Prevention of HIV Transmission from
Mother to Infant was conceived. This project is named after Elizabeth Glaser's
daughter, Ariel, who died of HIV infection at age 7.
Unprecedented in its scope, The Ariel Project is a "Mini-Manhattan project,"
bringing together key researchers and clinicians collaborating with a single goal
of finding a way to block transmission.
The Pediatric AIDS Foundation has committed $3 million a year for three years
to fund this project. The director of the project is Arthur J. Ammann, M.D., an
exceptionally experienced pediatric AIDS investigator. He has been active in the
field of AIDS since 1981, and involved with PAF since its inception.
An Outside Board of Scientists works with the core group of investigators to
define the necessary specific aims, determine the validity of the proposed
approaches and the significance of results and future directions. This board is
composed of individuals who have expertise in specific areas of the project, but
who are not funded by the project. These people are recognized for their ability
to direct new ideas in areas where creative thinking is required. Funding of this
unique project started in September, 1992.
1/94
The Pediatric AIDS Foundation
Emergency Assistance Program
The Emergency Assistance Program supplies hospitals serving significant
pediatric AIDS populations with funds to address their unmet, yet critical,
needs.
Presently we are serving close to 100 hospitals around the country with grants
up to $6,000 each. Requests may range from funding a partial salary for an
extra nurse or social worker, to a needed crib or stroller or piece of medical
equipment. This program may also provide transportation funds to help
children reach their AIDS treatment centers and not miss appointments due
to lack of car fare. A "discretionary fund" is available as well enabling
hospital staff to purchase badly needed clothing or food for children who are
to be discharged.
This program serves a wide population nationwide. It is a program that
every hospital seeing children with AIDS feels is critically needed.
Pediatric AIDS Foundation
Student Intern Awards
The goal of the Student Intern program is to encourage students to choose a
career in pediatric AIDS research or care. Participants may be undergraduates
or graduates and must apply through a sponsor who is their supervisor. This
sponsor must be recognized for their contributions to the field of pediatric
AIDS. The sponsor must indicate the relevance of their program to pediatric
AIDS. The program may be oriented toward fundamental research or clinical
research and care.
The total of each award is $2,000 for 8 weeks of work training.
1/94
Parent Education Program
--
"HIV/AIDS:
A Challenge to Us All"
The overall goal of the Pediatric AIDS Foundation Parent Education
Program, "HIV/AIDS: A Challenge to Us All", is to establish a guideline
for a parent meeting within the context of one school or a small
community. This program is geared towards educating the parents of
elementary and pre-school students; we do this by providing information
and guidelines regarding HIV/AIDS.
The kit, which consists of a parent meeting guide book and two accompanying
videotapes, was distributed free of charge in 1992, to 50,000 PTAs and other
education organizations across the country. In 1993, an additional 10,000 kits
were distributed nationwide, as well as 12,000 Spanish kits which were
distributed to Latino communities in major U.S. cities. The guide and one of
the videotapes gives all necessary information so any adult can set up a parent
meeting in their community. The other videotape demonstrates how parents
can answer children's questions about HIV/AIDS with age-appropriate
responses.
1/94
One Day Workshops
Our One Day Workshops Program began when we realized there were many
critical issues which could be addressed in a more targeted way than our
weekend Think Tank meetings. Many have arisen from questions facing the
Ariel Project. The first workshop was held to develop methods for detecting
maternal cells in fetal blood. Others have included Long Tern Survivors, AZT
Resistance, and Drug Development for Children.
Our main concern for these meetings is that at the end of the meeting we have a
realistic action plan.
Just as our Think Tanks result in a RFP being issued, our workshops must have
tangible results.
1/94
Pediatric AIDS Foundation
September 12, 1994
BOARD OF DIRECTORS
CHAIRPERSON
Elizabeth Glaser
Ms. Liz Bowyler
Peter Benzian
The White House
Susan DeLaurentis
Susan Zeegen
197 OEOB
Lloyd S. Zeiderman
Washington, DC 90500
EXECUTIVE ADVISORY BOARD
HONORARY CO-CHAIRS
Dear Liz:
President and Mrs. Ronald Reagan
Mrs. William E. Brock
At the request of Kathie Berlin, I am sending you background information
Bob Burkett
Alfred A. Checchi
about the Second Annual Pediatric AIDS Foundation KIDS FOR KIDS
Kathryn D. Checchi
Kitty Dukakis
benefit and family carnival on September 25th. This package includes an
Michael D. Eisner
invitation, fact sheet, list of Heroes to date, press clips from last year's
Susie Field
Senator Paula Hawkins
event, and background information about the Pediatric AIDS Foundation.
Elton John
Michael S Ovitz
Steven Spielberg
The Pediatric AIDS Foundation headquarters in Santa Monica will be
Jonathan M. Tisch
Alexander Vreeland
sending you their most recent Annual Report as well as other pertinent
Mrs. Pete Wilson
information and data regarding their funding, research and other related
HEALTH ADVISORY BOARD
projects.
CHAIRPERSON
Arthur J Ammann. M.D.
On Tuesday, our office will fax to you a list of carnival booths, as we
understand that Mrs. Clinton would like to select the booth she will be
Mary G. Boland. R.N. M S.N.
manning during the event.
Yvonne J. Bryson. MD.
Please call me if you have any questions or require additional information.
Michael S. Gottlieb. MO
I can be reached at 212-545-2435.
Margaret C. meagurty. M.D
I will contact you shortly to discuss this information in greater detail.
Many thanks and I look forward to speaking with you soon.
Dame V. Landers, M.D.
Kind regards,
James Oleshe M.D.
Evene
Jeaneane Judelson
Philip A. Pizzo. M.D.
Event Director
Pediatric AIDS Foundation
Aryn Rubinstein MD
KIDS FOR KIDS
Gwendolvn 3 Scott.
Lori Wiener. Ph.D. ACS W
CO-FOUNDERS Susan DeLaurentis/Elizabeth Glaser/Susan Zeegen
1311 Colorado Avenue. Santa Monica. California 90404
TEL: (310) 395-9051 FAX. (310) 395-5149
TARGETS for SEPTEMBER 22:
Kathleen Ambrose (Commerce)
Rajan Anand (Agriculture)
Brent Blakely (DOD- waiting for Judy Miller's confirmation)
Sarah Dowling (USIA)
Carmen Diaz (Agriculture)
Bill Kincaid (Education)
Barbra Leach (DOT)
Tina Thorne (DOD- maybe next week)
Will Wechler (DOD)
Lisa Richards (Federal Maritime Comm)
Charles Marcus (Commerce)
Diana Marino
Sharon Kennedy
Rob Murray (DOT)
Why is Pediatric AIDS Research Important?
Infection by the human immunodeficiency virus (HIV) is different in children than in
adults. Infected infants get sicker faster, their immune system may deteriorate more
quickly, and treatment may not work the same way or may have different
complications. Some treatments may not even be available for children until years after
they have been tested in adults.
Almost all new children with HIV infection acquire the virus from their mothers. Once
they are infected, they remain infected for the rest of their lives. The time that it takes
for the virus to produce symptoms or severe illness (AIDS) varies from child to child.
Some children may live a very long time without any symptoms of infection at all.
Not all infants born to HIV infected mothers get infected. Without treatment of the
mother during pregnancy and the infant after birth, about one fourth to one third of
infants become infected. It has been recently shown that treatment of HIV infected
pregnant women with Zidovudine (AZT) can reduce the number of infected infants to
less than 10%. That still leaves a significant number of infants who will be infected. But
progress is being made and these encouraging results demonstrate the success of
research in children.
For children who are infected, there are many remaining questions which will not, or
cannot, be addressed by research in adults. The developing brain of children is more
susceptible to HIV infection. Children do not mature normally and their growth is
impaired. Often, children experience more severe infections. Even ordinary childhood
infections may be fatal. When children loose their immunologic function, routine
childhood immunizations may not be effective. It is necessary to understand why the
immune system deteriorates more rapidly in children infected with HIV.
What is the Relationship Between
Pediatric Research and Adult Research?
Certain research questions can only be answered in the mother-infant population.
For example, will treatment of HIV infected mothers prevent HIV infection of
infants? Or, will an AIDS vaccine given at birth to an infant born to an HIV infected
mother prevent HIV infection? These and many other questions can only be
answered by studying mothers and infants. But answers to these questions may
benefit adults as well. If a vaccine were effective in preventing HIV infection of
infants, it might provide some clues to the kind of vaccine needed for adults. And
the effectiveness of some drugs might be more quickly seen in children whose
disease progresses more rapidly than adults. Positive research results are quickly
conveyed to all researchers so that the results of pediatric HIV/AIDS research can be
applied to as many individuals as possible. Research that the Pediatric AIDS
Foundation supports, while focusing on children is of benefit to all.
5/94
Pediatric AIDS Foundation
What is PAF? The Pediatric AIDS Foundation (PAF) is a national
non-profit 501 (c) (3) organization confronting medical problems
BOARD OF DIRECTORS
unique to children infected with HIV/AIDS. While our office is in
CHAIRPERSON
Santa Monica, CA, our funds are distributed worldwide.
Elizabeth Glaser
Peter Benzian
Susan DeLaurentis
How is PAF Unique? PAF is focused on creating a future that
Susan Zeegen
Lloyd S. Zeiderman
will offer hope for children with HIV/AIDS. Many organizations
are helping children survive on a day-to-day basis by raising money
EXECUTIVE ADVISORY BOARD
for food, medicine and lodging. PAF, however, is focused
HONORARY CO-CHAIRS
President and Mrs. Ronald Reagan
specifically on finding medical answers that will bring this hope.
Mrs. William E. Brock
Bob Burkett
PAF's Primary Goals: Through our Think Tanks PAF identifies
Alfred A Checchi
Kathryn D. Checchi
and funds critically needed pediatric AIDS research around the
Kitty Dukakis
Michael D. Eisner
world. The majority of the funds we raise go directly to researchers.
Susie Field
We fund investigator initiated research, as well as the Ariel Project,
Senator Paula Hawkins
Elton John
a directed collaborative effort to identify a way to block transmission
Michael S. Ovitz
from an infected mother to her infant.
Steven Spielberg
Jonathan M. Tisch
Alexander Vreeland
Mrs. Pete Wilson
PAF addresses these additional objectives:
HEALTH ADVISORY BOARD
- Providing funds to hospitals around the country which serve
CHAIRPERSON
children with HIV/AIDS through our Emergency Assistance
Arthur J. Ammann. M.D.
Program.
Mary G. Boland. R.N.. M.S.N.
- Encouraging students to enter the field of pediatric AIDS through
our Student Intern Award Program.
Yvonne J. Bryson. M.D.
- Developing and distributing our national Parent Education
Program for parents of elementary and pre-school age children.
Michael S. Gottlieb. M.D.
Administration is provided by a small full-time staff, generous
Margaret C Headenty M.D.
volunteers and in-kind donors committed to PAF's mission and
growth. PAF's administrative overhead is currently 5%.
Anna Belle Kaufman
Lunders.
D
The fight against pediatric AIDS is not futile. This is a battle we can
win by working together. This is a battle we must win for our
James Oleske. M.D.
children and for ourselves.
Philip A Pizzo. M.D.
The problem we face is urgency. Every month, indeed every day, is
critical. Children are dying who could be saved. Children are
suffering whose quality of life could be improved. As new drugs are
Arye Rubinstein. M.D.
tested, as lives are lengthened, our hope is strengthened.
Eventown 3 Scott. M
1/94
E. Richard Stiekin, M.D
Lori Wiener. Ph.D. A.C.S.W.
CO-FOUNDERS: Susan DeLaurentis/Elizabeth Glaser/Susan Zeegen
1311 Colorado Avenue. Santa Monica. California 90404
TEL: (310) 395-9051 FAX: (310) 395-5149
FOOD
Worldwide Statistics
The World Health Organization (WHO) predicts that by the year 2000, there will be 10 million
children infect d with HIV world wide.
1015
children will be orphaned by the death one of their parents
It's conservatively. estimated.th as many $10,000 20,000 children
THE
AIDS
906 cases 0
ildren
high
population to have HIV
Over 6,000 TY
ar.in the U.S
Over 50
TRAD
By the
CAT.
Data from the
Son
163 TOW About
HIV/AIDS affects children differ than adults The manifestations of pediatr c.AIDS lr
severe infections opportunistic well as failure of and
of
with
Childr
from
of this disease.
D
When you have achild with HIV/AIDS you almost always have a family with HIV/AIDS. An
infected father or mother can transmit the virus to their partner through
needles: Then an infected mother can passithe virus to her newborn in-utero or
Children and adolescents.with HIV/AIDS frequently have difficulty in getting access to/diagnosis
and
LIFESTYLE/COMICS/TRENDS
SECTION
E
WEDNE AY
VIEW
MARCH 21, 1990
Los Angeles Time
A Star in the
AIDS War
Elizabeth Glaser has become an unlikely but
premier lobbyist in the campaign against a killer
By GERALDINE BAUM
ing group for federal
TIMES STAFF WRITER
AIDS legislation. "In
fact. the thousands of
WASHINGTON
people we represent
This would be the hap-
could all gather under
F time in Elizabeth
the Capitol Dome and
Glaser's life if It were
not get half the atten-
not the saddest. She is
tion that Elizabeth
immersed in the flow of
Glaser gets when she
life and having a colos-
comes to town."
sal effect on the world
Most AIDS activists
around her. yet this
simply do not have the
intense. driven woman
cache to go right to
and her family are
then-President Ronald
fighting AIDS.
Reagan as Glaser did
"If I didn't have
two years ago when
AIDS. if I hadn't lost
she decided something
my daughter to it, if my
was wrong with a
son didn't have it. if my
world that didn't pay
life wasn't so sad. I
enough attention to
would be very fulfilled
children dying of the
by what I'm doing."
disease.
says Glaser. 42.
Most AIDS activists
"I'm realizing my
do not begin a day in
highest potential right
Washington with
now. I am able to com-
ABC's Joan Lunden
municate about some-
and end it with ABC's
thing that I think is
Ted Koppel. They can-
important way beyond
not plunk down com-
the scope of my own
fortably in the offices
life."
of U.S. senators such as
Even though this
Howard Metzenbaum
wealthy wife of ac-
of Ohio and Orrin
tor/director Paul Mi-
Hatch of Utah. Con-
chael Glaser is atypical
gressmen's wives do
of people confronted by Acquired Im-
not host lunches for them and cry at their
mune Deficiency Syndrome-she is not
compelling stories. And when other AIDS
poor. not a minority, not an intravenous
advocates testify before congressional
drug user. not gay-she has emerged as
committees. as Glaser did last week. they
the most powerful person pressing
do not anger the First Lady.
Washington for more money to fight the
That Elizabeth Glaser is not like most
epidemic.
people threatened by this disease is
"She IS the premier lobbyist on this
precisely why she has been so effective in
Elizabeth Maser 'If didn't have AIDS. if I hadn't lost my daughter to it, if my son
issue now," says Tom Sheridan. whose
Washington. where deep pockets and
didn't have 1. if my life wasn't so sad. 1 would be very fulfilled by what I'm doing.
AIDS Action Council is the largest lobby-
Please see GLASER. E6
At left. Glaser and Susan De Laurentis on their way to a meeting in Washington.
GLASER
power and it's important how she
"You we'l greeeeeeeeeat." Eliza-
uses it."
beth squeals at De Laurentis. slap-
ping her the high five and dissolv-
Continued from E1
G
laser says she tries to "carry
ing into laughter. Then. like a
glamour go a long way in impress-
this mantle" responsibly. In
giddy school teacher. Elizabeth
ing the powerful.
every speech. every interview. ev-
points out the sites to Paul. who is
But while the Hollywood glint
ery casual conversation. Glaser
sleepily watching the landmarks
has propelled Glaser into an influ-
says she is not lobbying (she even
whiz by.
ential spot in the federal bureau-
scoffs at the word. saying it implies
Although Elizabeth Glaser and
cracy. that alone cannot be credit-
she gets paid for her work. which
De Laurentis have been charging
ed for her success. It has come
she doesn't) for children alone.
around Washington for two years
from a combination of her hus-
"Every person with AIDS is
in an effort to joit this town into
band's celebrity, her own determi-
somebody's child." she lectures a
action to help AIDS-inflicted chil-
nation and the appalling reality of
reporter. "AIDS is not a political
dren and families. this is the first
her story.
issue. It's a virus and it kills people.
time Elizabeth is testifying at a
Glaser contracted the HIV virus
no matter who they are."
congressional budget hearing be-
that causes AIDS in 1981 from a
During a congressional budget
fore an inferno of television lights.
contaminated blood transfusion af-
hearing here last week. Glaser
And this is the first time she has
ter the birth of her daughter Ariel.
called on the federal government
brought Paul along for an appear-
During breast-feeding, she un-
to spend $70 million more in 1991
ance.
knowingly passed the virus to her
on pedia tric AIDS research and
"This is really big," Elizabeth
daughter. and then passed it to her
care but emphasized that money
keeps saying. "Everyone will be
son. born three years later. Ariel
must not be allocated at the er-
there."
died in 1988. Elizabeth and her son
pense of other AIDS programs.
Actually, the hearing room is
both test IV-positive. but so far
"The overall AIDS budget must
jammed with reporters and pediat-
show no symptoms of AIDS. The
have what it needs and within that
ric AIDS experts. who are also to
family continued to try to keep
umbrella a pediatric budget must
testify. But few congressmen show
their tragedy private-even after
be identified," she testified. "But
up. Only the two California mem-
Elizabeth had begun traveling to
the pediatric dollars must not be
bers of the nine-member Budget
Washington on behalf of AIDS
taken from other AIDS programs
Committee are seated on the wood-
causes in early 1988.
already under-funded."
en dais. Glaser doesn't seem dis-
But then in August. 1989. a year
There is an urgency in her voice
mayed. In fact. she seems thrilled
after Ariel's death. the Glasers
and an intensity in her stare that
to finally have an audience to
learned that a national tabloid
belie a warmth she exudes.
present a substantive look at the
planned to publish their story.
To be with her is to wonder:
issues.
Fearful of distortion. they went to
What was it like before tragedy
Paul is a reluctant accomplice. "I
the press themselves.
swamped her life?
am here to support my wife," he
"If the [tabloid] did anything
"Paul Michael Glaser and his
says tersely, the private man an-
good. it forced Elizabeth's hand
beautiful wife were like the Ken
noyed that he is being asked to
and all the horrible things we all
and Barbie of Hollywood: gor-
expose his deepest pain. "I'm the
worried about happening didn't
geous, successful, loving, great
supporting team."
happen." says Susan Zeegen. a
friends. great fun. very private,
And yet, while Paul is the Holly-
longtime friend who along with
very consumed with each other,"
wood star the cameras have come
Glaser and another friend. Susan
says Zeegen.
to gawk at, this is Elizabeth's show.
De Laurentis. founded the L.A.-
And now Elizabeth Glaser is
In Washington. among the bureau-
based Pediatric AIDS Foundation
completely consumed by a great
crats and politicians, she is the star.
two years ago. "Her story has
struggle for life-marshaling her
raised enormous awareness and a
friends and family to raise money,
almost $3 million so far. for the
A
small. thin woman with green
lot of money too. And all her
eyes and frosted hair cut in a
friends stuck by her."
Pediatric AIDS Foundation, flying
fashion she admits has been out of
Joel Johnson, Metzenbaum's
off to Washington. putting the
style for years. Elizabeth blends
legislative director. tries to explain
squeeze on politicians. talking on
well into conservative Washing-
why people in Washington listen to
the phone. making connections and
ton. She wears a green and black
Glaser: "She simply is not like most
finding new ways to make the
print dress, flesh-colored stock-
people who come here, make a case
world realize that the worst thing
ings. low black heels and the
and then go home in hopes that
that can happen to a mother has
requisite string of pearls.
everybody will do the right thing.
happened to her-she lost. a child-
The budget hearing lasts hours
She doesn't let go of a contact or
and no one else should have to face
but the media stays only long
anybody she can talk to."
that, particularly not her again.
enough to hear the Glasers' testi-
AIDS advocates have expressed
"Sometimes Elizabeth will be off
mony. While Paul talks. Elizabeth
concern that Glaser's impressive
to Washington and she'll say,
never takes her eyes off him. His
pitch for pediatric AIDS funding-
"They want the victim-mother
delivery is dramatic and moving.
there are 2.055 children younger
from Hollywood.' Zeegen ex-
"I know there are no guaran-
than 13 who are known to have the
plains. "and short of anything that
tees," he says, "My family is doing
disease-might distract politicians
would be harmful to her children
the best they can in a most difficult
from the problems of the other
and her husband. she's not proud.
situation."
120.000 people who have AIDS. and
she'll go out and do it."
Elizabeth is next. Although she
who. unlike children. are contro-
had hoped to avoid tears. her voice
versial back in the district.
"Who is going to vote against
I
t is 8:30 in the morning and a
breaks as soon as she begins talk-
limousine carrying Elizabeth
ing. "No mother ever really be-
Elizabeth Glaser?" asks Sheridan
and Paul Michael Glaser and their
lieves her child is going to die," she
of the AIDS Action Council. "She
entourage zooms past the sand-
says tearfully. "I didn't."
has the public image that members
stone and marble monuments of
After their testimony the Glasers
of Congress respond to. Believe me.
Washington to Capitol Hill. Eliza-
are chased down the halls of the
I've been lobbying for seven years
beth and Susan De Laurentis have
Rayburn Office Building by a me-
and I can't call members of Con-
just appeared on "Good Morning
dia swarm and they submit to a
gress at home. 'Nightline' isn't
America" and are frenetically re-
series of interviews in U.S. Rep.
interviewing me. She has a lot of
viewing their performances.
Barbara Boxer's crowded office.
It soon becomes apparent that
"So I turn it off here and when 1
of romance with Paul Michael
one of the important sound bites of
go home the emotion I've kept
Glaser. whom she met while driv-
the day will be Elizabeth's com-
away comes flooding back. It takes
ing down a boulevard. Their life in
two days for me to settle down. We
Hollywood, says Elizabeth. was
ment at the hearing that the Bush-
know that now."
es need to get more involved in
never glamorous because they
fighting the epidemic. Elizabeth
By late afternoon of the next day
chose to be "very private people. It
explains that she had asked to have
after a lunch meeting with con-
wasn't America's fantasy of Holly-
Mrs. Bush follow in Reagan's foot-
gressional wives. Glaser and De
wood. I cooked my own meals. I
steps and make a public service
Laurentis regroup in Sen. Metzen-
spent a lot of time with my friends.
announcement about people not
baum's sprawling office. making
My focus was always children. so
discriminating against children
themselves at home. Sen. Hatch.
when we had our first child I
with AIDS. But Elizabeth has not
who sent Glaser flowers after see-
stopped working. I always had
received a response from the
ing her on television. has an office
wanted to raise my children."
White House. Later. word comes
across the hall and she goes to
If there was any one moment in
'back from Mrs. Bush's press office
thank his staff.
which her life was completely
that the First Lady feels side-
Republican Hatch and Democrat
transformed. it was not when she
swiped by the Glasers' remarks.
Metzenbaum have made a rare
found out that she and her children
"Mrs. Bush is going to hate me. I
bipartisan effort by taking Glaser
had been exposed to a fatal disease,
know," Elizabeth says. "but what
under their wing. Last year they
nor even the day that her daughter
I'm saying is important-we have
organized a high-roller fund-raiser
died.
to raise awareness and the Bushes
for the Pediatric AIDS Foundation
Those are surreal memories that
are among the few people who can
in Washington that netted $1 mil-
she still finds hard to comprehend
do it." And in all her interviews she
lion. The senators provided the
and discuss.
continues to press the need to get
premier donors; Glaser brought the
the First Lady "on board."
What remains sharpest in her
stars.
Later. Elizabeth Glaser and De
memory is the day she decided to
"Are they all using me because
Laurentis begin a marathon of
"change the world." It happened in
of my Hollywood connection?" she
meetings, racing through the laby-
March, 1988. and she was sobbing
asks herself. groping for an expla-
rinth of federal buildings loaded
on the steps of the hospital where a
nation for her fantastic success in
down with position papers and
doctor had just told her that her
gaining political access here. "I
T-shirts designed by a little boy
daughter Ariel had 48 hours to live.
don't think SO. All of these rela-
named Zachary who died of AIDS.
tionships were in place and took a
The two women have a series of
lot of work.
15-minute meetings with con-
S of her best friends. and in a
he turned to Lucy Fisher. one
"I have a strong-enough un-
gressmen or their aides. with
derstanding of issues now." she
haze of tears blurted out, "I have to
whom they deftly discuss the com-
explains on the way back to her
change the world. I have to see the
plicated budget negotiations.
hotel. "but sometimes I don't un-
President. This can't be happen-
Two years ago, Glaser couldn't
derstand the roadblocks we're fac-
ing."
have found her way from the
ing. It's good to have people in
An ordinary person would have
offices of the Senate to the House.
these offices to turn to. When I
comforted her pal with a hug, but
she admits, and she couldn't have
came to Washington that first time.
Fisher was no ordinary friend. She
differentiated among all the acro-
it was Government 101 for me. But
is also the daughter-in-law of
nyms-like OMB (Office of Man-
it gets easier every time."
Charles Wick. who was Reagan's
agement and Budget) or FTE (Full
chief of the U.S. Information
Time Equivalent federal employ-
ee).
V
ery little in Elizabeth Glaser's
Agency and one of his best friends.
life prepared her for her cur-
"I was so frustrated." recalls
But now she lights up when a
congressman explains to her about
rent crusade, but. as she explains it.
Glaser. "I had been fighting for
"downward negotiations" during
she was raised to reach out to
Ari's life. keeping it all quiet from
others.
the
community
yet
she
was
budget time and laments how the
"peace dividend" will be spent.
She grew up in the upper-middle
going to die anyway. I felt I had
class suburbs of Long Island. the
just better do something about it or
"Sometimes. when we're run-
daughter of a businessman and a
[my son] and I were also going to
ning around like this and talking in
director of urban renewal.
die.
this other language I feel like we're
in Las Vegas." Glaser says. "and
"I was raised to be politically
"There was so much wrong I
we've completely lost a sense of
aware and astute and committed to
didn't know where to begin," she
time and reality."
issues of helping other people." she
says.
says. "My mother particularly
Over the past years. she has not
S
he also acknowledges that
taught me this. We never talked
known where to stop.
Washington is a fantastic es-
about those things in fiery debate.
She will not be "finished." she
cape: "When I'm here doing busi-
My mother simply was an exam-
says, until the government and the
ness I have to separate myself from
ple."
doctors take care of the AIDS
emotional reality. I have to close
After earning a master's degree
problem. until there is enough
the dam because I can't be effec-
in education, Glaser ended up in
money in the federal budget to root
tive here if I let all the emotions
Los Angeles. where she taught
out every possibility and perhaps
rule me.
elementary school and fell into
discover a cure for AIDS.
what began as a "very L.A." type
"You know, there is very little
ego involved in all this." she says.
"I'm not looking for recognition
publicity was the last thing I
wanted to have."
But now she is using it to get
what she wants:
"One of the things that my life
has taught me is that I have
nothing to lose by being honest. I
don't have the time to play games.
I'm also talking about an issue that
people really do care about. And
until it is handled appropriately.
I'm going to keep talking."
National THE 1017 nizations
questions about HIV and to find out about clinical trials:
AIDS Clearinghouse
(800) 458-5231
sire rdins HIV/AIDS
r.Disea Common
(404) 302-2473
1917.04
tate Health Division
(503) 73 -4029
ns-regardir public
AIDS-POLICY-CENTER
TEL : 202-785-3579
Sep 21'94 19:09 No.008 P.01
fax
To
Jennifer Kline
Org.
Fax
456-9878
Tel.
From
AIDS Policy Center
AP
For Children, Youth & Families
910 Seventeenth Street NW, Suite 422
Washington, DC 20006
Pages
2
Notes
Corrected
If you have any questions
regarding this fax, please call
Tel. (202) 785-3564
Fax (202) 785-3579
Pediatric AlDSFoundation
BOARD OF DIRECTORS
September 13, 1994
CHAIRPERSON
Elizabetn Glaser
Peter Benzian
Liz Bowyler
Susan DeLaurentis
Susan Zeegen
The White House
Llova S. Zeiderman
197 OEOB
EXECUTIVE ADVISORY BOARD
Washington, DC 90500
HONORARY CO-CHAIRS
President and Mrs. Ronald Reagan
Dear Liz,
Mrs William 5 Brock
Boo Burkett
Thoughts
This information is a compilation of all grants we have awarded
Rathren C Checus
Kitt, Dehakis
in the categories of ARIEL PROJECT, LONG TERM
Michael D Eisner
Susie Field
SURVIVORS, and our regular cycle of Research Grants and
Senator Paula Hawan's
Scholar Awards.
Eltor John
Michael S 0.00
Serven Solathop
I am also including our 1993 Annual Report, a pediatric AIDS
A Cach
Alexander vreeland
fact sheet with statistics compiled by the CDC, and one more
Mrs. Pete Wilson
PAF packet of information.
HEALTH ADVISORY BCARD
CHAIRPERSON
Thank you so much for your assistance.
Arthur j. Ammann. MD
Mary 0 Bound R.N., M.S N.
Sincerely,
Yvorine J. Bryson M.C
susee zugen
Susie Zeegen
Mico R Sottlien. MD.
Co-founder
James Cleske MO =
Philip A. Pizzo. MD
Arve Rubinstein N D
Wiener
CO-POUNDERS under Service Leegen
311
000
IL 1310-395-0051
3103955149 PEDIATRIC AIDS FOUND
960 P02
MAR 14 94 11:35
6.2566
ec: Patti
Evelyn
Pediatric AIDS Foundation
1000 Children with AIDS
We should do R
BOARD OF DIRECTORS
14 March 1994
CHAIRPERSON
Elizabeth Glaser
ASAP re date
Peter Benzian
Susan Delaurentis
Mrs. Hillary Rodham Clinton
Susan Zeegen
The White House
Lloyd S. Zeiderman
1600 Pennsylvania Avenue
EXECUTIVE ADVISORY BOARD
Washington, DC 20500
HUNORARY CO CHAIRS
President and Mrs Ronald Reader
Dear Hillary,
Mrs. William E. Brock
Bob Burkett
afrom A. Checem
This is a follow-up of my earlier letter concerning the Pediatric
Bathryn D. Checon
Mitty Dukakis
AIDS Foundation event in New York City. We were so happy
Michael D Elsner
use Fleki
when you said you would be the honorary chair and that you plan
Senator Faula Hawkirr,
to attend the event. But now I am writing because, due to
Elton lohr.
Michael 5. Ovitz
complications with dates of the New York Co chairs, we have
Steven Spielberg
Jonathan M. Tisch
changed the date. The event will now bc held on Scptember 25th.
Alexander Vreetand
'Its Poto WHEC:-
Needless to say, we hope this date will work well. We now
HEALTH ADVISORY BOARD
have underwriting from Harper's Bazaar, and already have two
CHAIRPERSON
$100,000 sponsors.
:rthur 1. Artimann M D
Mary C Boland KN MSN
I know the event will be a huge success - but nothing means
more to me than your participation. It sends so many important
Evenne J. Bryson. M D
messages to so many.
Michael S United M.O.
I am hoping to get to Washington the beginning of May. As
always, I think you're doing a great job.
Margarer C. Heagarty. MO
Anna Sette Kaufman
With love,
Carrier . Landers. M.D
Edinglaith
Olesse. M D.
Elizabeth Glaser
Co-founder
PRINT A P.220. M 0
Arye Rubinstein VD
A South M 0
F. Bichard Stienm MD
Lori Wiener PAO. ACS W.
CO-FOUNDERS: Susan 001 aurnitis/Ellzabuth Glasser Susar Capitor
311 Colorado Avenue. Senta Monica. California 95134
a
TL 13/06/2015 905' FAX (310) 395-51-19
bee; Evie
Patti
September
THE WHITE HOUSE
March 17, 1994
Elizabeth Glaser
Pediatric AIDS Foundation
1311 Colorado Avenue
Santa Monica, California 90404
Dear Elizabeth:
Thank you for letting me know that
the date of the New York event has been
changed to September 25th. I am en-
couraged by your fundraising successes,
and will pass on the new date to my
scheduling office.
If you are going to be in Washington
in May, please let my assistant, Pam
Barnett, know and perhaps we can get
together for a visit.
It was good to hear from you again.
Sincerely yours,
Hillary Hillary Rodham Clinton
I think about you all the
time. (Cathic Berlin spent a
Comple of nights with me and
we talked about you leadership
and Chample. Hope youfeel all on love -
COMM/RESEARCH
ID: 2024562239
SEP 23'94 17:20 No 002 P.02
THE WHITE HOUSE
WASHINGTON
September 22, 1994
MEMORANDUM TOLIZ BOYER
From:
leff Levi, Office of the National AIDS Policy Coordinator
Subject:
O&A on HIV issues
David Harvey of the AIDS Policy Center for Children, Youth and Families has sent a good
outline of talking points. There are a few difficult issues that the press might raise:
In light of the indings that giving AZT to pregnant women with HIV dramatically
reduces the chances that her baby will be infected, does the Administration support
mandatory testing of pregnant women?
The Public Health Service is in the process of reviewing its recommendations for pregnant
women with HIV. A meeting on this specific subject was held this week. There are difficult
issues to balance in making this policy decision; it is not as simple as mandating 8 test. If
mothers at risk fear that through mandatory testing they might lose custody of their child or
be punished in some other way, they might not seek out pre-natal care. That would be a bad
solution for both the mother and the child. While a very emotional issue, this is clearly one
that the public health professionals and not the political community should resolve.
Background: Initial studies show that with AZT therapy, transmission from mother to
child can be reduced from about 25% to about 8%. But the solution of mandatory
testing might, paradoxically, actually reduce the number of high-risk mothers who
seek pre-natal care - -- for fear that they will be stigmatized for being infected and/or
might lose custody of their children after birth. Where quality counseling is offered,
90 percent of pregnant women will accept voluntary testing.
The Public Health Service now supports a program where almost all new borns are
tested for HIV in a blinded study. Even though there are now interventions that might
delay the onset of disease for the infant, the government has resisted unblinding the
results. Why won't the government help these innocent children?
It is certainly the responsibility of the federal government to assist all children with HIV.
That is the purpose of Title IV of the Ryan White CARE Act, which provides funding for
pediatric care services. The testing of new-borns is a complicated medical and public health
issue: the results on new borns tell us more about the mother than about the child. I know
that the Public Health Service is constantly re-evaluating this issue in light of the changing
science and I think this issue is best loft to the public health professionals to decide.
COMM/RESEARCH
ID 2024562239
SEP 23'94 17:21 No 002 P.03
Memo to Uz Boyer/September 22. 1994/Page 2
Background: All new-borns are part of a blind screening program funded by the
CDC The testing that is done through this program is designed to teach us about the
underlying level of infection among pregnant women in the US. Because the testing
is blinded, po informed consent is sought from the mother. The issue that has been
raised is whether this should be unblinded so that there can be closer monitoring of
the now Gorns of infected mothers, follwed by early diagnosis and intervention with
the new born could occur. The PHS has continued to recommend that these tests not
be unblinded for a number of reasons -- including the fact that a positive test from a
new hom is telling us the infection status of the mother, not the child. Because the
infant is carrying the mother's HIV antibodies, all infants with HIV-infected mothers
will test positive, even though only between one-fourth and one-third of them will
actually be infected. Clearly, those infants with infected mothers need close
monitoring and follow up. But it has been the consistent recommendation of the PHS
that this be accomplished through voluntary testing of the mother -- both for her
benefit and for the child's benefit.
Kristine Gebble, the President's first AIDS Czar, resigned in August. It is now almost
October. When is the President going to appoint a replacement?
A search is now under way for a new National AIDS Policy Coordinator. Interviews have
bocn held and, Just as importantly, there has been extensive consultation with the HIV
community about how this office should be structured and what type of person should fill this
important role. In the meantime, this office continues to function -- we have been fortunate
to have as interjm coordinator Patsy Fleming who is on loan from the Department of Health
and Human Services. She has worked on AIDS issues for over a decade; she has made sure
that no time is being LOST in focusing our national policy. She has already met with the
President several times to discuss these issues.
Background: Interviews are expected to be completed next week; a final decision may
be forthogming within a few weeks thereafter.
Cong. Nadler New York has Introduced the AIDS Cure Act, which would mandate a
Manhattan Project on AIDS. Why doesn't the Administration support this bill?
While I am not familiar with the specifics of the AIDS Cure Act, I can say that this
Administration is fully committed w finding a cure for AWS and pushing the research
agenda as rapidly as possible. We have a new director of the Office of AIDS Research, Dr.
William Paul. That office has been given broad new authorities to make budgetary and
programmatic decisions and cut through red tape under legislation that this Administration
pushed through Congress last year. And just as importantly, we have put money behind this
effort: AIDS research (along with other AIDS programs) has been one of very few
"investment" areas throughout the government identified as a priority for increased funding
in my Administration. In the two budgets since FY 1993, NTH AIDS research funding has
increased nearly 25%, more than for any other disease.
COMM/RESEARCH
ID:2024562239
SEP 23'94 17:21 No 002 P.04
Memo to Liz Beyer/Septcember 22, 1994/Page 3
Background: The notion of a Manhattan Project that brings together scientists in one
place to find a cure is discredited throughout the biomedical community. Better
coordination of activities, more discretion in the research budget, etc. are laudable
goals 11 all of which can be achieved through the now structures created and now in
place under the NIH Revitalization Act of 1993. The law requires the OAR to
develop a comprehensive plan and budget for all NIH AIDS research. This plan is
the first blueprint for the entire NIH AIDS research effort and will determine resource
allocation across the NIH. The OAR recently completed the FY 1996 NIH Plan for
HIV-Related Research, which was developed through a unique and Inclusive process
designed to find new approaches. The OAR sought the expertise of the NIH
leadership; scientists and researchers from government agencies, academia,
foundations, and industry; a number of Nobel laureates; HIV-infected men and
women; and AIDS community representatives. The result of this review has been a
rededidation to basic research -- so that we can learn more about HIV and develop
better treatments.
Memorandum to Liz Bowyer
From: Ruby Shamir
Date: 9/20/94
Subj: Pediatric AIDS "Kids for Kids" and "A Time for Heroes"
"Kids for Kids, M New York, N Y; August 18, 1993
This benefit for the Pediatric AIDS Foundation which was held at Industria
Superstudio and underwritten by Vogue Magazine raised just over $1 million. Anna
Wintour, editor in chief of Vogue magazine, Donna Karan, and Elizabeth Glaser
chaired the events whose proceeds went to fundings Ariel project
Celebrities included Spike Lee, Dustin Hoffman (who also participated in "A Time for
Heroes in L.A.), Joan Rivers, Tom Brokaw, Wallace Shawn (actor and playwright),
and artist Jennifer Bartlett. For more artist/celebs. see attached article.
"A Time for Heroes," Los Angeles, CA; June 5, 1994
This annual picnic and carnival fundraiser for the Pediatric AIDS Foundation which
was held on the grounds of the Brentwood Ranch of Ken Roberts was underwritten
by People magazine and the Milken Family Medical Foundation (Michael Milken was
able to attend this year for the first time after getting out of jail) The event, in its
fifth year, raised $1.6 million for the charity to fund research and provide care and
education.
Celebrities in attendance were: Jack Nicholson and Robin Williams (dunking booth);
Candice Bergen and Tom Hanks (Wheel of Fortune); Meryl Streep and Tony Danza
(ring toss); Ann Archer (fish pond). Some of the following celebs. brought their
kids: Ted Danson, Kim Basinger, Andy Garcia, Dustin Hoffman, Joe Pesci, Jimmy
Connors, Oscar De La Hoya, Magic Johnson.
Other celebs. include: Goldie Hawn, Elle MacPherson, Sandy Koufax, Henry Winkler,
Mike Myers, Jason Priestly, Michelle Pfieffer, Billy Crystal, Warren Beatty, Richard
Gere, Cindy Crawford and more (see articles). O.J. Simpson was there (eight days
before the body of Nicole Simpson and her male friend were found).
PAGE
14
Pediatric
RY of Level 2 printed in FULL format.
kids46ids
ght 1994 The Times Mirror Company
Los Angeles Times
sytheroes
8, 1994, Wednesday, Home Edition
SECTION
rart E; Page 4; Column 3; View Desk
LENGTH: 435 words
HEADLINE: RSVP;
FUN, GAMES, A SERIOUS CAUSE
BYLINE: By BETTY GOODWIN, SPECIAL TO THE TIMES
BODY:
It's more than one colossal Kodak moment, although "A Time for Heroes, the
annual picnic and carnival fund-raiser for the Pediatric AIDS Foundation, is
most definitely that, too. There were celebrities (categories: sports, movies,
television, modeling) everywhere you turned at the former Robert Taylor ranch,
now the home of Ken Roberts, in Brentwood on Sunday. Meryl Streep, Andy Garcia
and Jimmy Connors would be sauntering across one patch of lawn; Tom Hanks, Elle
MacPherson, Sandy Koufax and Kim Basinger across another.
The event, now in its fifth year and underwritten by People magazine and the
Milken Family Medical Foundation, was the unusual sort of gathering where
paparazzi were barred at the gate, but a phalanx of Polaroid-snapping volunteers
encouraged people to pose with their favorite, usually camera-averse, stars.
"It's inspiring," Goldie Hawn said. "Love is very invigorating. If people are
happy it gives you energy. This day is about a very positive, loving endeavor."
Over at the dart game booth, Dustin Hoffman was smiling for picture No. 349,
or something like that. Next in line was retired Dodger Ron Cey, taking a break
from his booth, to grab a family shot with the renowned actor. "Why? He does
great work," Cey said.
Although the idea is to have the stars staff old-fashioned carnival booths,
the games often get lost in the action. When Jack Nicholson was a no-show for
his noon appearance at the dunking booth, no one seemed terribly perturbed.
"Jack usually comes whenever he comes, allowed an event organizer. Robin
Williams, who was cast for the 1 p.m. slot, slipped into his Nicholson voice and
had the people in line in stitches.
Nicholson finally ambled in about 2, putting on his own show. "Wait till he
gets reloaded here now.
Let 'er rip," he instructed a ball-thrower hoping
to see Mike Myers get dunked. "Man, he's damp," said Nicholson, when the
inevitable happened.
Although no one would dispute the display of star power, the event's true
centerpiece is Elizabeth Glaser, co-founder of the Pediatric AIDS Foundation
with Susan Zeegen and Susan DeLaurentis.
"She is my hero, said Henry Winkler. "I personally love her from my hair to
my toes. Glaser, who has been HIV-positive for 13 years, injected the day's
PAGE 15
Los Angeles Times, June 8, 1994
one troubling note when she told the gathering: "For those of you who aren't in
my daily life, I've been having a much harder time the last four months." But
she "When added that young HIV-positive survivors she knew gave her hope and strength.
I'm struggling, I'll remember that miracles happen," she said.
GRAPHIC: Photo, Tom Hanks takes his turn at manning the Wheel of Fortune during
picnic and carnival fund-raiser for the Pediatric AIDS Foundation. i Photo,
PAF "Beverly Hills 90210" star Brian Austin Green meets a fan. DONNA GILMARTIN /
LANGUAGE: ENGLISH
LOAD-DATE-MDC: June 9, 1994
PAGE
16
10TH STORY of Level 2 printed in FULL format.
Copyright 1993 The Times Mirror Company
Los Angeles Times
June 9, 1993, Wednesday, Home Edition
ECTION: View; Part E; Page 2; Column 3; View Desk
ENGTH: 406 words
EADLINE: 'A TIME FOR HEROES': THE REAL STARS ARE THE KIDS
YLINE: By BETTY GOODWIN, SPECIAL TO THE TIMES
ODY:
Meryl Streep ran a bowling game. Annette Bening took charge at the ring toss.
haquille O'Neal instructed kids at basketball. Debbie Allen taught dance.
ichelle Pfeiffer and Sandy Koufax took turns heading up a baseball game booth.
The casting didn't always make sense, but you can be sure that the annual
ediatric AIDS Foundation "A Time for Heroes" fund-raiser Sunday afternoon was
ot your ordinary country fair.
The annual event on the grounds of the sprawling Brentwood home of Ken
oberts, the former Robert Taylor ranch, is heavily populated by entertainers
and sports stars. Many come with children and nannies in tow. Among ticket
)uyers were studio chiefs Sherry Lansing, Peter Guber, Mark Canton, Jeffrey
atzenberg and Alan Ladd Jr.
Even Jason Priestly, who attracted a lineup of kids impatiently awaiting a
hoto op, was impressed. "Hey, there's Jimmy Connors. Hey, there's Warren Moon.
And Anne Archer. And Michelle Pfeiffer. I get like a little kid out here, he
said. "The turnout is unbelievable."
Magic Johnson, Jack Nicholson, Warren Beatty, Candice Bergen, Billy Crystal,
Cindy Crawford, Richard Gere and Michael Richards of "Seinfeld" (with his hair
tamed) were among the volunteers explaining the intricacies of games like
'splish splash" and "fish pond" to the PG-13 crowd. Peter, Paul and Mary, Sheila
and Little Richard entertained.
"You can't be a parent and not do it," said Bergen, departing her post at
'super strike." "I postponed a trip to New York to be here. I'm really grateful
for the opportunity to participate."
"I come every year, said Ladd. "It's an extraordinary thing Elizabeth does.
Extraordinary woman."
Elizabeth, of course, is Elizabeth Glaser, who received tainted blood during
transfusion when her daughter, Ariel, was born and has been HIV positive for
L2 years. Ariel died of AIDS, and Glaser's son, Jake, 8, contracted the virus in
the womb. Glaser co-founded the Pediatric AIDS Foundation with Susan Zeegen and
Susan DeLaurentis in 1988.
People magazine and the Milken Family Medical Foundation underwrote the
event, and no one seemed to enjoy it more than Michael Milken. His foundation
has sponsored the afternoon for three years, but this was his first time
PAGE 17
Los Angeles Times, June 9, 1993
here.
"I had been detained for the last couple of years," said the convicted junk
ond king, who was in prison. "It's different being here than having my daughter
ell me about it over the phone."
RAPHIC: Photo, Elizabeth Glaser, left, Magic Johnson and Sharon Stone at "A
ime for Heroes" fund-raiser for Glaser's Pediatric AIDS Foundation. RANDI
ALKIN
ANGUAGE: ENGLISH
PAGE 27
DATE: SEPTEMBER 20, 1994
CLIENT:
LIBRARY: NEWS
FILE: CURNWS
OUR SEARCH REQUEST IS:
PEDIATRIC AIDS AND KIDS FOR KIDS AND NEW YORK
UMBER OF STORIES FOUND WITH YOUR REQUEST THROUGH:
LEVEL 1
11
PAGE
28
6TH STORY of Level 1 printed in FULL format.
Copyright 1993 The New York Times Company
The New York Times
April 25, 1993, Sunday, Late Edition - Final
ECTION: Section 9; Page 4; Column 1; Styles of The Times
ENGTH: 267 words
EADLINE: EGOS & IDS;
Season For Hope
YLINE: By Degen Pener
ODY:
Last Sunday's welcome spring weather brought out a fun-loving crowd to the
Kids for Kids" benefit for the Pediatric AIDS Foundation. Held at the Industria
uperstudio and underwritten by Vogue magazine, the event, which was fashioned
fter a New York street fair, raised just over $1 million.
Outside, celebrities like Spike Lee, Dustin Hoffman and Joan Rivers worked
erchandise and game booths.
Inside, an art room, organized by the painter Jennifer Bartlett, was a big
raw, despite its lack of windows. The previous evening, Ms. Bartlett had
over a the room with huge sheets of white paper and had drawn a bare-bones map
New York.
Gu ts and their children then added their own visions of the city. The
rtist Red Grooms created a collage of Central Park. Tom Brokaw wrote "Marla's
e" inside an area marked "Future Trump City." The artworks were donated to
ediatric AIDS wards around the city.
Wallace Shawn, the actor and playwright, hadn't drawn anything. "I was in
harge of keeping order at the materials table," he said, as resolutely
essive as ever.
Had he seen anyone draw anything of interest?
"No," he said. "I was concentrating on maintaining an orderly arrangement of
rayons."
Another benefit for children also took place on Tuesday night. Camille Cosby,
bove left, the wife of Bill Cosby, was honored at the Plaza by the Northside
enter for Child Development, which provides psychiatric counseling and remedial
ducation for children in East Harlem. Mrs. Cosby, who last year earned a
octorate in education, is working on a film about Winnie Mandela.
ANGUAGE: ENGLISH
AD-DATE-MDC: April 25, 1993
A
S
PAGE 29
7TH STORY of Level 1 printed in FULL format.
Copyright 1993 The New York Times Company
The New York Times
April 25, 1993, Sunday, Late Edition - Final
SECTION: Section 9; Page 6; Column 1; Styles of The Times
LENGTH: 17 words
HEADLINE: EVENING HOURS;
For Artists of All Ages
BODY:
A benefit for the Pediatric AIDS Foundation drew supporters to the Industria
Super Studio, April 18.
GRAPHIC: Photos: 4:20 P.M.: FRANK STELLA reclined on the floor of Industria
Super Studio to draw with JASMIN BARR during the benefit for the Pediatric AIDS
Foundation. 4:10 P.M.: RED GROOMS and JENNIFER BARTLETT at the "Kids for Kids"
benefit, which raised more than $1 million. Artworks created during the event
were donated to pediatric AIDS wards around the city. 5:20 P.M.: ROY
LICHTENSTEIN and CAROLYN KOVACS help the cause. Celebrities in art, sports,
fashion and entertainment turned out for the event. 6:10 P.M.: ROLANDO BLACKMAN
of the New York Knicks and VERNELL, his son. 4:45 P.M.: The Knicks star PATRICK
EWING offered some tips to young fans. 6:15 P.M.: The choreographer MARK MORRIS
joined a tot in dancing outdoors. 3:30 P.M.: ALEX KATZ collaborating on a
drawing with guests at the benefit, which resembled a large street fair. The
Pediatric AIDS Foundation helps treat and prevent H.I.V. infection in children.
(Bill Cunningham/The New York Times)
LANGUAGE: ENGLISH
LOAD-DATE-MDC: April 25, 1993
09/19/94 11:46
202 690 7560
HHS NAPO
001
Office of the National AIDS Policy Coordinato
Executive Office of the President
750 17th Street, N.W. Suite 1060
Washington, D.C. 20500
Phone: (202)690-5560
Fax: (202)690-7560
Deliver To: Ling
Sent From: Kitty Lloyd Soe Feances
Number of Pages: \ + Cover Fax Number: 202-456-2239 Date: 9/19/14
Message:
Please call you receipt of this Sav
Thanks,
Kitty
002
09/19/94
11:46
202 690 7560
HHS NAPO
SELECTED CLINTON ADMINISTRATION
ACCOMPLISHMENTS FOR HIV/AIDS
Created the Office of National AIDS Policy (ONAP) to coordinate the national
response to HIV/AIDS.
*
For FY 1994 there has been a 9% increase in funding for prevention activities at the
Centers for Disease Control and Prevention (CDC).
Since taking office, President Clinton has increased funding by 89.4% for treatment
and services through the Public Health Service.
The National Institute of Health Revitalization Act of 1993 was signed into law to
coordinate the monies allocated for HIV/AIDS within the NIH. The appointment of
Dr. William Paul as the director of the new NIH Office of AIDS Research.
The creation of the National Task Force for AIDS Drug Development to streamline
drug development and encourage government-private collaborative efforts.
A Presidential Directive mandating training for the three million federal employees.
The training will teach 'both cmployees and supervisors about AIDS 101, basic HIV
sensitivities, non-discrimination guidelines and progressive workplace policies.
The appointment of the HIV/AIDS Presidential Advisory Council to continue national
community involvement and diverse input on how to implement the National HIV
Action Agenda of ONAP.
President Clinton's Health Security Act will provide guaranteed health benefits for all
Americans that can never be taken away, regardless of their HIV - status.
*
The launch of the national Preventive Marketing Initiative, which consists of a public
information campaign and the creation of a national partners group. The message is
aimed at providing necessary information to 18-25 year olds to protect them from
HIV infection. In addition, ONAP lent its support to the Country AIDS Awareness
Campaign targeted at rural Americans.
*
Continued building of strong partnerships between ONAP and various religious,
community and business organizations.
Continued aggressive efforts by the Department of Justice in pursuit of the Americans
with Disabilities Act and its relationship to People Living With AIDS.
Coordinating the HIV/AIDS activities of all government Agencies/Dcpartments more
vigorously while encouraging the involvement of those not previously active in
HIV/AIDS issues.
CDC has begun the implementation of the community planning process intended to
obtain community input in setting priorities for prevention activities to be conducted
locally with federal funding.
APRIT. 1994 - ONAP
From: Jeff Levi To: Jennifer Klein
Date: 9/22/94 Time: 22:19:20
Page 2 of 3
Talking Points on Federal Response to Pediatric AIDS
I am proud to say that the National Institutes of Health is undertaking a full-
scale attack on every aspect of pediatric AIDS. This is in no small part due to
the tremendous efforts on the part of Elizabeth Glaser -- in getting funding for
pediatric research in the early years of the epidemic. We now have new
leadership at NIH that is committed to waging a fight for a cure working with
organizations like the Pediatric AIDS Foundation in developing new strategies
for combatting HIV.
Funding for pediatric AIDS research at the NIH has increased over 25% in the
two budgets the Clinton Administration has presented. We inherited a budget of
$144 million in FY 1993; it rose to $175 million in the current fiscal year; and
it will rise again to $183 million in the appropriations bill that just cleared a
conference committee this week. In this two-year period, AIDS research has
increased at a faster pace than any other disease -- demonstrating our
understanding of the magnitude of the challenge before us.
Pediatric AIDS research has also been an area where we have seen
tremendous pay back on our investment. We now know how to dramatically
reduce the likelihood of transmission of HIV infection from pregnant mothers to
their children. But we are certainly not resting on those laurels. The NIH
funds over 22 pediatric AIDS clinical trials units; there are additional trials
under way at other centers. Over 4,200 children were in NIH-sponsored clinical
trials last year. Our work will not stop until a successful treatment is found for
both children and adults.
Good research is only half the battle. Wc also must make sure that those
children and their families who do have HIV disease get good treatment -- that
they have the chance to take advantage of these new breakthroughs. The
federal government has a special role to play in assuring access to care for
children with HIV because of the disproportionate impact that HIV has on poor,
minority children.
Our administration has supported a 30% increase in funding for Title IV of
the Ryan White CARE Act over the last two years. Title IV is designed to
assure comprehensive care systems linked to research for HIV affected children
and their families -- through community-based, family-centered care programs.
Funding has risen from $20 million in 1993 to $26 million in the new fiscal
year starting October 1. We are now funding 49 projects throughout the
From: Jeff Levi To: Jennifer Klein
Date: 9/22/94 Time: 22:20:52
Page 3 of 3
country which serve between 45,000 and 50,000 clients.
There is another group of young people we must be concerned with -- and
that is adolescents who are getting HIV at an alarming rate. Over 46,400 -- or
19% of all reported cases of AIDS in the US are among young adults in the 20-
29 year old range. That means, given the time lag between infection and
becoming sick, that most of them were infected in their teenage years. We as a
nation must begin doing something about it. The Centers for Discase Control
last year undertook a major new Prevention Marketing Initiative -- a multi-level
campaign targeted at adolescents and young adults designed to encourage them
to delay sexual activity or, if they choose to be active, to at least be safe. We
can, and must, do more in this area -- and I am pleased that the FY 1995 budget
about to come to the President for signature will include a $47 million increase
in funding for HIV prevention activities at the CDC.
ID:
PAGE
1/4
SEP-21-94 18:26 FROM:
CDC
CENTERS FOR DISEASE CONTROL AND PREVENTION
"The Nation's Prevention Agency"
CENTERS FOR DISEASE CONTROL
AND PREVENTION
Washington Office
202-690-8598
FAX: 202-690-7519
DATE 9/21
PAGES 3
+
Cover
TO
Junnifer Klein
Phone: 202-456-2599
Fax:
202-456-2878
FROM
Sharon Kath,
Phone:
202-690-8598
COMMENTS/NOTES
Please call to discuss. D have other material you
may want to have messengered to you as well. D hope
this is helpful.
SEP-21-94 18:26 FROM:
ID:
PAGE
2/4
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
AIDS Cases Reported Among U.S. Children
A dozen years ago, researchers detected the first cases of
AIDS in children; in the United States today, HIV infects
1,300-2,000 newborns each year and has become one of the top
10 leading causes of death of young children. Through June
1994, the Centers for Disease Control and Prevention (CDC),
the nation's prevention agency, received reports of 5,734
AIDS cases among children less than 13 years of age. And
the number of cases among children is increasing: 39% of
these total cases have been reported in the last 2-1/2
years.
Of the 5,734 children with AIDS, 3,100 (54%) reportedly have
died. In 1991 (the latest year for which final mortality
data are available), HIV/AIDS was the seventh leading cause
of death among children 1 to 4 years of age in the United
States. HIV/AIDS was the second leading cause of death
among black children ages 1 to 4 in Florida, Massachusetts,
New Jersey, and New York and the second leading cause of
death among Hispanic children ages 1 to 4 in New York
(second to unintentional injury).
Cases of AIDS among children have been reported from 48
states, the District of Columbia, Puerto Rico and the U.S.
Virgin Islands. Fifty-one percent of the cumulative AIDS
cases reported among children are from New York (1,531), New
Jersey (522) and Florida (876).
As with adults and adolescents, children who are members of
racial or ethnic minority populations have been
disproportionately affected by the HIV/AIDS epidemic. The
majority of children reported with AIDS were (non-Hispanic)
black (56%) or Hispanic (24%). Nineteen percent of children
with AIDS were (non-Hispanic) white, 0.5% were Asian/Pacific
Islander, and 0.3% were American Indian/Alaska Native (race
was unknown for the remaining 0.2%).
Thirty-nine percent of children reported with AIDS were
diagnosed before their first birthday, 47% were diagnosed
between 1 and 5 years of age, and 15% from 6 to 12 years of
age. Forty-eight percent of these children were female and
52% were male.
HIV infection in children is most often acquired through
perinatal transmission, i.e., from an HIV-infected mother to
her fetus or infant before or during birth. Research has
shown that most transmission probably occurs during
pregnancy or labor and delivery. HIV infection can also be
transmitted through breastfeeding. In the United States,
89% of cumulative AIDS cases were attributable to perinatal
SEP-21-94 18:27 FROM:
ID:
PAGE
3/4
transmission of HIV (and 93% of cases reported in 1993).
The majority of mothers of these children acquired HIV
infection through injecting drug use (38%) or heterosexual
contact (27%).
Although perinatal transmission accounts for the vast
majority of HIV infections in children, a small number of
children have become infected through other ways. Before
routine screening of the U.S. blood supply began in 1985,
some children became infected through blood transfusions or
through use of clotting factor to treat hemophilia. Of
cumulative pediatric AIDS cases in the United States,
children with coagulation disorders account for 4% and
children with transfusion-acquired AIDS account for 6%.
Twenty-seven states conduct surveillance of HIV infection as
well as AIDS in children. Through June 1994, these states
reported 948 children who are infected with HIV, but have
not developed AIDS.
In addition to collecting data on cases of HIV infection and
AIDS and analyzing trends in these data, CDC funds state
health departments to conduct surveys of HIV seroprevalence
in certain U.S. populations. One of these surveys is among
childbearing women. The HIV Survey in Childbearing Women is
an ongoing, national serosurvey initiated in 1988. It is
designed to measure the prevalence of HIV infection in women
delivering infants in the United States and to monitor this
rate over time. The survey provides very accurate data for
states and health care providers to use in focusing their
efforts to provide HIV counseling and testing, prenatal
care, and follow-up for women at greatest risk of HIV
infection.
CDC continues to study the course of illness in HIV-infected
children and to evaluate ways to prevent serious effects of
HIV infection in children. For example, CDC research
indicates that the time from infection with HIV to the
development of AIDS varies from months to years in children,
but on average is about 3 years. It is not possible to
predict which children will get sick early and which will
survive for a long time before getting sick. Statistical
analyses suggest that an estimated one-fourth of perinatally
infected children are short-term survivors who are likely to
die by age 4 years. The remaining three-fourths are
long-term survivors who are likely to survive more than 7-8
years.
In addition, CDC is currently examining the need to revise
its guidelines on preventing Pneumocystis carinii pneumonia,
the most common serious infection that affects HIV-infected
children, especially infants in the first year of life.
Since the earliest AIDS cases were reported in children,
SEP-21-94 18:27 FROM:
ID:
PAGE
4/4
careful and persistent research conducted with the
cooperation of generous and committed families has led up to
a recent major breakthrough. An important scientific study
has found that we can reduce substantially this deadly
infection in the infants of many HIV-infected mothers by
using the drug zidovudine (AZT). Recently, researchers have
shown that if AZT therapy is given to an HIV-infected woman
during pregnancy and delivery, and to the child for a short
period after birth, the probability of her child's being
infected may be reduced from one chance in four to about one
in twelve.
Investigators found that both mothers and infants tolerated
the AZT treatment well, with no significant short-term side
effects other than reversible mild anemia (low red blood
cell counts) in some infants. The study investigators plan
to follow the infants for a number of years because the
long-term consequences of AZT therapy are unknown.
Researchers will monitor their growth and development and
look for any unusual illnesses among them. In addition, they
will follow the women in the trial for 6 months after
delivery. Longer term follow-up of the mothers is being
planned. However, because of the possibility of reducing
HIV transmission during pregnancy and birth, women who are
or who may become pregnant should know if they are infected
with HIV so that specific interventions can be offered early
in pregnancy.
Additional efforts to prevent HIV infection in children must
be directed toward preventing infection in adolescents and
adults--including childbearing women and their sex partners.
CDC has numerous HIV prevention activities directed to the
general population, as well as populations at increased risk
of HIV infection. For example, CDC is conducting behavioral
research under the Comprehensive AIDS and Reproductive
Health Education Study (Project CARES) to develop,
implement, and evaluate interventions for the prevention of
HIV infection and AIDS in women and infants. CDC has also
developed a multisite research design and intervention
program for the Prevention of HIV in Women and Infants
Demonstration Projects to evaluate HIV prevention services
in facilities and at the community level. In this project,
barriers to prevention and care will be reduced through
outreach and the provision of services in nontraditional
settings, such as drug treatment centers and homeless
shelters.
In addition to the children who are infected with HIV, many
others are "affected" by HIV and AIDS. Researchers estimate
that 20,000 children in the United States have already been
orphaned because their mothers have died of HIV/AIDS. This
number is expected to reach 125,000-150,000 by the end of
this decade.
HUMAN
SERVICES
USA
HEALTH
DEPARTMENT OF HEALTH & HUMAN SERVICES
or
September 21, 1994
Per your conversation with Dr. Lisa Simpson.
SERVICES
HUMAN
USA
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
HEALTH
of
Agency for Health Care Policy
and Research
September 1994
Rockville MD 20852
Agency for Health Care Policy and Research (AHCPR)
Clinical Practice Guideline
Evaluation and Management of Early HIV Infection
Dissemination Activities Targeting Pediatric Providers
and Caregivers of Children Living with HIV
In January 1994, Assistant Secretary for Public Health Dr.
Philip Lee announced to the American public that they could
get free copies of HIV and Your Child (in English and
Spanish), along with the other guideline materials, by
calling the CDC National AIDS Hotline (800/342-AIDS) .
As a result of this promotion and numerous others, 292, 729
English language copies, and 59,993 Spanish language copies
of HIV and Your Child have been distributed.
The AHCPR worked with the American Academy of Pediatrics to
notify most of the nation's pediatricians (47,543 Academy
members) of the availability of the clinical guideline on
treating children living with HIV, as well as HIV and Your
Child. AHCPR also notified 30,000 nurse practitioners of
the availability of these materials by working with the
American Academy of Nurse Practitioners
AHCPR formed a partnership with the National Pediatric AIDS
Resource Center to distribute copies of the guideline and
HIV and Your Child through their clearinghouse and network.
SENT BY:ASPEN SYSTEMS CORP.
: 9-22-94 :11:25AM ;
ROCKVILLE, MD. ->
301 227 8283:# 2/ 4
American
Academy of
Pediatrics
April 1994
Dear Colleague:
Primary health care for people living with the Human
141 Northwest Point Blvd
Immunodeficiency Virus (HIV) can make a difference.
PO Box 927
Early diagnosis and care are essential. A new
Elk Grove Village, IL 60009-0927
information tool for pediatricians and other primary
Phone 708/228-5005
Fax 700/228 6007
care practitioners is available to help health care
providers evaluate and manage patients with early HIV
infection effectively and efficiently.
The chairperson of the AAP Provisional Committee on
Pediatric AIDS and other members of the Academy
served on the federal Agency for Health Care Policy
and Research (AHCPR) panel and actively participated
in the development of Management and Evaluation of
Early HIV Infection. This clinical practice
guideline sponsored by the AHCPR and endorsed by the
AAP is described in the enclosed brochure.
You may order multiple free copies of the Guideline
President
and the accompanying Quick Reference Guide for
Betty A. Lowe, MD
physicians to share with your peers. Understanding
Vice President
HIV and HIV and Your Child are for patients and
George D. Comerci, MD
families and may be ordered in quantity for
Past President
Howard A. Pearson, MD
distribution to them. These patient materials are
available in both English and Spanish.
Executive Director
Joe M. Sanders, Jr, MD
The AHCPR Guideline demonstrates that managing HIV in
Board of Directors
its early stages is not as difficult as it may seem.
It contains practical, succinct chapters on selected
Gilbert L. Fuld, MD
Keene, New Hampshire
aspects of early HIV infection to help you develop a
regimen of care. It also provides information to
Louis Z. Cooper, MD
New York, New York
share with your patients. Topics include disclosing
HIV status, diagnosing specific conditions associated
Anthony DeSpirito, MD
Interlaken, New Jersey
with early HIV infection and coordination of care.
Joseph R. Zanga, MD
There are specific recommendations for women,
Richmond, Virginia
adolescents and children. Please take the time to
Robert E. Hannemann, MD
review the enclosed material which is available in
Lafayette, Indiana
both English and Spanish. Single copies may be
Thomas F. Tonniges, MD
obtained by calling the CDC National AIDS Hotline 1-
Hastings, Nebraska
800-342-AIDS (2437) or you may obtain multiple copies
Carden Johnston, MD
and more information by writing to:
Birmingham, Alabama
Donald E. Cook, MD
AHCPR HIV Guideline
Greeley, Colorado
CDC National AIDS Clearinghouse
Leonard A. Kutnik, MD
PO Box 6003
San Diego, California
Rockville, MD 20849-6003
SENT BY:ASPEN SYSTEMS CORP.
; 9-22-94 :11:26AM ;
ROCKVILLE, MD. ->
301 227 8283;# 3/ 4
April 1994
Page 2
In addition, the Academy has recently developed a compendium of
AAP Guidelines on Fediatric Human Immunodeficiency Virus (HIV)
Infection. This compendium of AAP policy statements and excerpts
from AAP Manuals addresses various topics regarding HIV infection
specific to pediatric patients. Included within the compendium
are policies on HIV education in schools, pediatric trainees
caring for patients with HIV infection, perinatal HIV testing,
HIV infection in day care and foster care, athletic participation
of the HIV infected patient, administrative policies regarding
HIV, preventing transmission of HIV, protecting HIV-infected
children, and HIV infected students and school personnel. Copies
of the compendium are available through AAP publications (1-800-
433-9016) for $9.95 for members ($19.95 for non-members).
AS you know, pediatricians play a crucial role in early
diagnosis, treatment and care of the HIV-infected child. You are
the first line of defense against HIV - for your patients and
your community. Men, women and children of all ages, races, and
ethnicities are increasingly affected. Statistics show that the
rates of infection are increasing most rapidly among women,
children, and adolescents. We encourage you to order and make
use of the AHCPR guideline Management and Evaluation of Early HIV
Infection, the patient brochures, and the compendium of AAP
Guidelines on Pediatric Human Immunodeficiency Virus (HIV)
Infection.
Sincerely,
Sanders,
Executive Director
American Academy of Pediatrics
JMS:vku
SENT BY:ASPEN SYSTEMS CORP.
; 9-22-94 26AM ;
ROCKVILLE, MD.
301 227 8283 4/ 4
AMERICAN ACADEMY OF NORSE PRACTITIONERS
Incortanated Lowel, Massachusetts 1985
Administration: Capitol Station, LBJ Building P.O. Box 12848 Austin, TX 78711 (512) 442-4262 Fax (512) 442 8469
Governmental Affairs: P.O. Box 40013 Washington, DC 20016
Dear Nurse Practitioner Colleagues:
The American Academy of Nurse Practitioners is assisting the federal Agency for Health Care Policy and
Research (AHCPR) in reaching nurse practitioners concerning the recent AHCPR publication regarding
HIV management. Primary care for people living with HIV can runks a difference. Early diagnosis and
care are essential. A new information tool for nurse practitioners and other primary care providers is
available to help health care providers evaluate and manage early HIV infection effectively and efficiently.
Management and Evaluation of Early HIV Infection, a clinical guideline sponsored and published by
AHCPR.
You may order multiple free copies of this guideline and the accompanying Quick Reference Guide for
olinicians Please share these materials with your peera. Understanding HIV and HIV and Your Child are
brochures for patients and may be ordered in quantity. The patient materials are available in both English
and Spanish.
Nurse Practitioners play 2 crucial role in carly diagnosis and treatment. You are the first line of defense
against HIV -- for your patients and for the public. As you know, people with HIV live everywhere. Men,
women, and especially children of all ages, races and exhnicities are increasingly affected. Statistics show
that the rates of infection are increasing most rapidly among women, children and adolescents. The good
news is that with early diagnosis and treatment, people infected with HIV can remain symptom-free longer.
The AHCPR Guideline will show you that managing HIV in its early stages is not as difficult as it may
secon. This guideline provides practical, to-the-point chapters on selected aspects of early HIV infection to
help you provide a regimen of care. There are specific recommendations for women, adolescents and
children. Please take the time to review the enclosed material. We encourage you to order and make use of
the guideline publications. If you wish additional capies, single copies of the net or any part of it, call the
CDC National AIDS Hotline, 1-800-342-AIDS (2437). You may obtain raultiple copies and more
information by writing to:
AHCPR HIV Guideline
National AIDS Cheuringhouse
P.O. Box 6003
Rockville, MD 20849-6003
Sincerely,
JJ
Judith Dempster, DNSc. NP-C, FNP, President
American Academy of Nurse Practitioners
SEP-21-94 18:59 FROM: RESOURCE CENTER
ID: 2027853545
PAGE 1/4
fax
To
Jennife Je Kline
Org.
office 456 of 2878 The First Cody
Fax
Tel.
From
Prd 1 day
AIDS Policy Center
AP
For Children, Youth & Families
910 Seventeenth Street NW, Suite 422
Washington, DC 20006
Pages
Notes
If you have any questions
regarding this fax, please call
Tel. (202) 785-3564
Fax (202) 785-3579
AIDS-POLICY-CENTER
TEL 202-785-3579
Sep 21'94
19:09 No.008 P.02
APAI
AIDS Policy Center For Children, Youth & Families
BOARD or DIRECTORS
MEMO TO:
Strai Saluburg, MPA, President
The First Lady
Brooklyn
Hillary Rodham Clinton
Wyndolyn Hell, MD. Vicc-President
Atlanta
Julio Hidalgo, Se.D. Treasurer
Balumone
THRU:
Jennifer Kline
Decision De Drsus, Secretary
Hrous
Office of the First Lady
Marc Alben, Heg.
Washington
Deborah Alkxi
FROM:
David C. Harvey
net
Hoston
Executive Director
Barbara RN, MSN
San Antonio
Mary Bolland. RN. MSN
Nework
SUBJ:
Talking Points
Katir. Hond
Boston
Pediatric AIDS Foundation Benefit
Kelth Copcland
Mr. Pleasure. form
Paul Filzgerski. MSW
DATE:
September 21, 1994
Providence
Claim Hall, MS
San Francisco
CC:
Carol H. Rasco
Lillie Hayes
Philadelphia
Patsy Fleming
Elizabeth Jeppson. Ph.D.
Bethesda. MD
Rolando Jinname-Mercado. MPHE
BY FAX:
202-456-2878
San luan
Bossita Judon
Atlania
Michael Kalscr. MD
New Orleans
Marcy Kaplan, MSW
Las Angeles
Per my phone conversation with Jennifer Kline, attached are talking points
Glorin Mali
Albany
for the speech at the Pediatric AIDS Foundation benefit. Please contact me if I
Derothy Mann
Phtladelphia
can provide any additional information.
Scan Sasser
Sun Francisco
Owendolyn Scon, MI>
I assume you have already covered remarks related to: (1) The White
Miami
Janet Shalwir, MD
House commitment to AIDS and budget increases for AIDS programs; (2) The
Sun Francisco
Mildred Williamson. MSW
White House commitment to helping to provide compassionate care for those
Chicago
individuals and families affected by HIV infection and AIDS and fighting
David C. Harvey, MSW
discrimination and stigma; (3) the relationship between AIDS and health care
Executive Director
reform; (4) The White House commitment to moving quickly to hire a new
national AIDS policy coordinator; and (5) rapidly growing AIDS cases among
African-American and Hispanic women who may unknowingly pass the virus to
their children if they become pregnant.
Talking Points
1.
I am pleased to be here with you today to recognize the work of the
Pediatric AIDS Foundation. The Foundation funds vitally needed private
sector research to find a cure and find ways of blocking HIV transmission.
910 Seventeenth Street NW. Suite 422. Washington, DC 20006
Tel. (202) 785-3564
Fax (202) 785-3579
SEP-21-94 18:59 FROM: RESOURCE CENTER
ID: 2027853545
PAGE 2/4
AIDS Policy Center For Children, Youth & Families
BOARD OF DIRECTORS
MEMO TO:
The First Lady
Shen Saltzberg. MPA. President
Brooklyn
Hillary Rodham Clinton
Wyndolyn Bell. MD. Vice-President
relance
Julia Hidalgo, Sc.D. Treasurer
Baltimore
THRU:
Jennifer Kline
Jecinia De Jesus. Secretary
Office of the First Lady
Bronx
Marc Aftert, txq.
Washington
Deborah Allen
FROM:
David C. Harvey
Delt
Baston
Executive Director
Barbara Aranda-Naranjo. RN, MSN
San Antonio
Mary Boland. RN. MSN
Newark
SUBJ:
Talking Points
Karie Bond
Pediatric AIDS Foundation Benefit
Boston
Keith Copeland
Mr. Pleasant. lowe
Paul Fitzgerald. MSW
DATE:
September 21, 1994
Providence
Chris Hall, MS
San Francisco
CC:
Carol H. Rasco
Lillic Hayes
Philadelphia
Patsy Fleming
Elizabeth Juppson. Ph.D.
Bethesde. MD
Rolando Junenez-Merus60. MPHH
BY FAX:
202-456-2878
San Juan
Bonna Judon
Atlanta
Michael Kaiser, MD
New Orleans
Marcy Kaplan. MSW
Los Angeles
Per your request, attached are talking points that I quickly developed after
(iloria Maki
Albany
my phone conversation today with Jennifer Kline. The talking points are brief
Dorothy Mam
Philadelphia
and to the point. Please contact me if I can provide any additional information
Sean Sasser
on any of the issues mentioned.
Sun Francisco
Gwendolyn Scon, MD
Miami
Janet Shalwing MD
I assume you have already covered remarks related to: (1) The White
Son Francisco
House commitment to AIDS and budget increases for AIDS programs; (2) The
Mildred Williamson. MSW
Chicago
White House commitment to helping to provide compassionate care for those
David C. Harvey. MSW
individuals and families affected by HIV infection and AIDS and fighting
Executive Director
discrimination and stigma; (3) the relationship between AIDS and health care
reform; (4) The White House commitment to moving quickly to hire a new
national AIDS policy coordinator; and (5) rapidly growing AIDS cases among
African-American and Hispanic women who may unknowingly pass the virus to
their children if they become pregnant.
Talking Points
1.
I am pleased to be here with you today to recognize the work of the
Pediatric AIDS Foundation. The Foundation funds vitally needed private
sector research to find a cure and find ways of blocking HIV transmission.
910 Seventeenth Street NW. Suite 422. Washington, DC. 20006 Tcl. (202) 785-3564 Fax (202) 785-3579
SEP-21-94 18:59 FROM: RESOURCE CENTER
ID:2027853545
PAGE 3/4
2.
I also know of the good work of the Foundation and I know of the Foundation's yearly
"heroes" benefit that takes place in Los Angeles. All of you are heroes tonight who have
come to this event and have donated money for AIDS research. There is no bigger hero
that I wish to honor tonight than Elizabeth Glaser who fights with dignity, courage and
tenacity. Her work alone has helped so many."
3.
I am also pleased to be here with you today following the wonderful news that for the
first time, we have made progress in blocking the transmission of the HIV virus. You
know better than I the results of a National Institutes of Health research study which has
shown that by offering the drug zidovudine - or AZT to pregnant women with HIV
infection, that the risk of HIV transmission from mother to child is dramatically reduced.
This news alone tells us that our investment in AIDS research is worth it.
4.
The task before the federal agencies and The White House is to ensure that this lifesaving
treatment is offered to all women with HIV infection who want it. It will require
coordination between the various agencies of the Department of Health & Human
Services to coordinate outreach, HIV counseling and testing, prenatal care, OB/GYN
services, and comprehensive care for women and young women with HIV infection who
are pregnant. And it will require the private sector to help us get the word out.
5.
And I also know that HIV disproportionately impacts the African-American and Hispanic
communities, especially women and children from these communities. We must be
sensitive to the cultural issues in providing access to this new promising treatment by
building trusting partnerships between providers of services and communities of color
where trust may be lacking.
6.
And we must not rest on this study alone. NIH and the Pediatric AIDS Foundation must
continue to fund studies to assess the safety and efficacy of giving AZT to pregnant
women and children over time, and we must carefully counsel women as to their options
regarding this new therapy to ensure that all women understand the risks and benefits of
this new promising therapy.
7.
We must not rest on this study alone. NIH and the private sector must continue to study
how to block other routes of HIV transmission through funding vaccine research,
behavioral studies to determine what methods of outreach, counseling and testing
programs are effective, and other research programs so that we can prevent new HIV
infections among children, youth, women and men.
8.
We must not rest on this study alone. New HIV infection rates among America's youth
is unacceptable and a horrendous failure on our part. We must effectively educate and
care for our young people. New HIV infection rates among young gay men are
unacceptable and we must address the special needs of this neglected group.
SEP-21-94 18:59 FROM: RESOURCE CENTER
ID:2027853545
PAGE 4/4
9.
Finally, we must not rest on this study alone. In light of this promising new AZT
therapy, calls for mandatory HIV testing of all women is not justified. Offering HIV
counseling and testing, informed consent, and balanced information about the promising
results of AZT therapy for women who may be infected with HIV should be offered to
all as a standard medical routine.
10.
The real task before all of us today is to discover ways of preventing HIV infection in
the first place and to finally discover an absolute cure so that no one has to suffer from
diseases associated with HIV infection and AIDS.
PAGE 002
SEP 20 94 14:37
14:53
MCHB
Fact Sheet
Maternal and Child Health Bureau
Health Resources and Services Administration Public Health Service U.S. Department of Health and Human Services
Pediatric AIDS
Acquired immune deficiency syndrome (AIDS) in children was first described in 1982 when it became apparent that this
then-mysterious disease could be transmitted by blood transfusions or the blood products used to treat hemophilia. Perinatal
transmission from mothers infected through intravenous drug use or sexual contact was recognized at about the same time.
Initially, it was difficult to distinguish AIDS from the rare and equally puzzling congenital immunodeficiency diseases in children.
By 1984, the numbers of children with AIDS began to escalate, especially in New York City, Newark, and Miami. That year,
the Division of Maternal and Child Health (now the Maternal and Child Health Bureau) cosponsored the first National Meeting on
Pediatric AIDS which concluded that AIDS did occur in children. that the number of children involved was undercounted in the
Centers for Disease Control and Prevention (CDC) surveillance system, and at infected infants and children and their families
were subject to discrimination and sometimes barred from basic services.
In 1986, at a second National Pediatric AIDS Meeting, physicians and other health care workers. social workers, and
educators shared information about the clinical spectrum and treatment efforts. A new confidence resulted from the increasing
knowledge about the etiology and transmission of AIDS. Moreover, it was recognized that most existing approaches to the
treatment of children with special health needs were applicable to children with HIV infection.
A third national meeting in 1987, the Surgeon General's Workshop on Children with HIV Infection and Their Families,
focused on prevention of human immunodeficiency virus (HIV) infection in children and on the difficulties of caring for children
already infected. In addition to summarizing current knowledge about AIDS in children, workshop participants-who included
clinical and research physicians, health providers, economists, educators, parents, members of the clergy. and media
representatives-presented 82 recommendations for future directions in research, prevention, and services. These
recommendations, contained in the workshop report, provide a useful framework for meeting some of the challenges presented by
HIV infection in children.
In 1988, the Pediatric AIDS Health Care Demonstration Program was initiated, with funds appropriated under the Public
Health Service Act. In 1994, the program is permanently authorized under Title IV of the Ryan White Comprehensive AIDS
Resources Emergency (CARE) Act. The program is administered by the Maternal and Child Health Bureau, which now refers to it
as the Pediatric/Family HIV Health Care Demonstration Program, reflecting the fact that projects serve families, not just children,
that are infected with or at risk for HIV.
Incidence of Pediatric AIDS
AIDS is transmitted in several ways: from infected mothers to their infants; through exposure to infected body
fluids, primarily blood; and through sexual contact with an HIV-infected partner.
4,906 children with AIDS have been reported to CDC through September 1993. About one-third of these cases were
reported since 1990 with perinatal transmission the risk factor in 90 percent. The epidemic among children has
spread from large metropolitan areas to smaller cities and rural communities, particularly in the Southeastern
United States.
AIDS is already one of the leading causes of death for all children and the ninth leading cause of death among
children 1 to 4 years of age.
1,167 adolescents with AIDS ages 13-19 years and nearly 13,000 young adults with AIDS ages 20-24 years have been
reported to the CDC through September 1993.
AIDS is the sixth leading cause of death in young people between the ages of 15 and 24 years.
Women are the fastest growing segment of the AIDS population. The number of women infected with HIV.
particularly within communities of color, continues to grow and spread beyond the large urban epicenters to smaller
urban and rural settings.
SEP 20 '94 14:38
PAGE. 003
TOE
40,702 cases of AIDS in female adolescents and adult women have been reported to the CDC through September
1993. Almost one-third oi these cases (12,000) were reported in the past year. The majority of women are exposed
to HIV through heterosexual contacts. and sexual contact with drug users.
AIDS is the fifth leading cause of death in women in the United States and the leading cause of death in New Jersey
and New York City.
The Pedistric/Family HIV Program
The purpose of the Pediatric/Family IIIV Health Care Demonstration Program is to improve and expand the infrastructure of
comprehensive care services in order to increase the access of HIV/AIDS-affected women, infants, children, and youth to a
comprehensive. community-based, family-centered system of care. As a result of the transfer of the program to Title IV, the focus
of the program is further expanded to develop innovative models that link systems of comprehensive community-based medical
and social services for the affected population with the National Institutes of Health and other clinical research trials. Funds
support innovative strategies and models to organize, arrange for, and deliver comprehensive services through integration into
ongoing systems of care and support from appropriate financing mechanisms. The service delivery systems assure the delivery of
high-quality care at the appropriate level, with an emphasis on ambulatory care services that may reduce unnecessary hospital
stays.
Three categories of projects have been funded: Pediatric AIDS Projects which provide or coordinate comprehensive, family-
centered health, social, and support services; Comprehensive Care Consortia with the unique requirement that private sector
funding must match public funding; and National Issues Projects which provide information, training, and technical assistance to
expand national resource capacity and impact national program development.
in fiscal year 1993, 44 projects were funded in 20 States, the District of Columbia, and Puerto Rico for a total cost of $20.9
million. Thirty-nine of the projects funded were AIDS demonstrations, two were consortia, and three were on national issues.
Eighty-four percent of the projects' clients are from poor, minority families with limited access to transportation and housing.
Currently, 39 percent are Hispanic and 43 percent are African American. In fiscal year 1994, the program is funded at $22 million.
Program Accomplishments
The pediatric/family HIV projects have proven to be effective In their ability to organize and improve patient access
to a comprehensive system of services. Between 1991 and 1992, the pediatric/family HIV projects have increased the
unduplicated number of individual clients served by each project by 87 percent with a total of 28,738 clients served.
The number of families served more than doubled each year between 1988 and 1990, indicating the program's
commitment to maintenance of the family unit in the face of this devastating disease.
Children in the majority of projects studied were able to participate in clinical trials that gave them access to state-
of-the-art treatments. Access to state-of-the-art treatment is provided in coordination with primary medical, social,
and family support services which are made available to family members of children served by all of the projects.
The program has improved the capacity of health and social service professionals, community-based organizations,
and families to address the demand of the growing epidemic. In each project, individual grantees have made efforts
to strengthen provider capacity within their communities and States through education, training, and peer support.
A recently completed National Issues Project grant has documented the cost of caring for children with HIV and
AIDS, and has proposed reimbursement methodology appropriate to pediatric AIDS financing.
Projects are identifying HIV-positive pregnant women through outreach, counseling, and testing. These efforts have
resulted in earlier identification of both HIV-positive women and HIV-exposed newborns, with appropriate followup
care.
Two national resource centers have been funded by the program. The National Pediatric HIV Resource Center
provides information and technical assistance, and has developed curriculum for multidisciplinary training
programs for health administrators and care providers. The Institute for Family-Centered Care provides technical
assistance to support families affected by HIV and AIDS.
For further information. contact the chief, Hemophilia and AIDS Services Branch, at (301) 443-9051.
1/94
09/20/94
18:31
202 690 7560
HHS NAPO
Office of the National AIDS Policy Coordinato
Executive Office of the President
750 17th Street, N.W. Suite 1060
Washington, D.C. 20500
Phone: (202)690-5560
Fax: (202)690-7560
Deliver To: LIZ
Sent From: FRANCESS E. PAGE R.N., MPH
CERVICE FELLOW/PREVENTION SPECIALIST
Number of Pages:
+ Cover Fax Number: 456-2239 Date: 9/20
Message:
JEND OF YEAR 1993 STATS
2 076 DOCUMENTS.
MORE TO CME Tomorrow!
76Am
09/20/94
18:31
202 690 7560
HHS NAPO
002 037
Table 4. Male adult/adolescent AIDS cases by exposure category and ra ethnicity, reported
in 1993, and cumulative totals, through December 1993, United States
White. not Hispanic
Black, not Hispanic
Hispanic
Cumulative
Cumulative
1993
Cumulative
total
1993
total
1993
total
Exposure category
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
Men who have sex with men
32.18R
(73)
131,617
(78)
10.509
(30)
36.446
(41)
6,519
injecting drug use
(43)
23,146
(45)
4,634
(11)
13,493
(8)
10,961
(38)
32,218
(37)
5.872
(38)
Men who have sex with men and
19,516
(38)
inject drugs
3.296
(7)
12,933
(8)
1.871
(6)
6,762
(8)
853
(6)
3.458
Hernophilia/coagulation disorder
(7)
868
(2)
2,490
(1)
110
(0)
270
(0)
71
(0)
238
Hotcrosexual contact.
( 0)
701
(2)
1,795
(1)
1,833
(5)
4,207
(5)
752
( 5)
1,628
(3)
Sex with injecting drug user
267
875
744
2,256
210
650
Sex with person with hemophilia
7
14
1
4
4
5
Sex with transfusion recipient
with HIV infection
26
76
29
50
20
42
Sex with HIV-infected person,
risk not spooilied
407
830
1,059
1,887
515
930
Receipt of blood transfusion,
blood components, or tissue
408
(1)
2,521
(1)
178
(1)
662
(1)
83
(1)
390
1)
Risk not reported or identified¹
1.886
(4)
4,231
(3)
3,330
(12)
7.627
(9)
1.151
(8)
2,566
5)
Total
43,987
(100)
169,080
(100)
28,792 (100)
88,192 (100)
15,301 (100)
50.942
(100)
Asian/Pacific Islandor
American Indian/Alaska Native
Cumulative totals
Cumulative
Cumulative
Cumulative
1993
total
1993
total
1003
total
Exposure category
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
Men who have sex with men
509
(77)
1,699
(80)
177
(63)
432
(63)
49.963
(56)
193.652
(62)
Injecting drug use
33
(5)
87
(4)
27
(10)
74
(11)
21,571
(24)
65.512
(21)
Men who have sex with men and
inject drugs
24
(4)
63
(3)
46
(16)
122
(18)
6,098
(7)
23,360
(7)
Hemophilia/coagulation dicorder
12
(2)
36
(2)
8
(3)
18
(3)
1,069
(1)
3,058
(1)
Heterosexual contact:
16.
(2)
29
(1)
6
(2)
12
(2)
3,317
(4)
7,679
(2)
Sex with injecting drug user
6
12
1
5
1.232
3,793
Sex with person with hemophilia
-
-
-
-
12
24
Sex with transfusion recipient
with HIV infection
1
2
-
1
76
31
Sex with HIV-infected person,
risk not specified
9
15
5
7
1,997
3675
Receipt of blood transfusion,
blood components. or tissue
13
(2)
73
(3)
1
(0)
5
(1)
686
(1)
3.660
(1)
Risk not reported or identified
58
(9)
148
(7)
16
( 0)
25
(4)
6,461
(7)
14.657
(5)
Total
665 (100)
2,135 (100)
281 (100)
688 (100)
89,165 (100)
311,573
(100)
See Figure 7.
²includes 541 mon whoce recc/cthnicity is unknown.
Vol. 5, No. 4
9
HIV/AIDS Surveillance Report
4
003.037
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HHS NAPO
Table 5. Female adult/adolescent AIDS cases by exposure category and race/ethnicity,
reported in 1993, and cumulative totals, through December 1993, United States
White. not Hispanic
Black, not Hispanic
Hispanic
Cumulative
Cumulative
Cumulative
1993
total
1993
total
1993
total
Exposure category
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No
(%)
No.
(%)
Injecting drug use
1,889
(46)
4.835
(44)
4,420
(48)
12.459
(52)
1.458
(44)
4.317
(48
Hemophilia/coagulation disorder
16
(0)
51
(0)
7
(0)
16
(0)
3
(0)
( 0)
Heterosexual contact:
1.557
(38)
3.910
(35)
3.139
(34)
7.613
(32)
1 474
(44)
3.790
(42)
Sex with injecting arug user
670
1.864
1,368
4.432
762
2.518
Sex with bisexual male
231
GBO
194
486
81
186
Sex with with hemophilia
56
154
3
21
4
10
Sex with clusion recipient
with HIV infection
50
182
33
70
21
56
Sex with HIV-infected person.
risk not specified
550
1.030
1.535
2,604
606
021
Receipt of blood transfusion.
blood commonents. or tissue
235
(6)
1,429
(13)
187
(2)
659
(3)
90
(3:
3d2
( 4)
Risk not reported or identified
406
(10)
824
(7)
1,459
(16)
3063
(13)
299
( 0)
sec
(0)
Total
4,103
(100)
11,050
(100)
9,220
(100)
23.810
(100)
3,324
(100)
9 066
(100)
Asian/Pacific Islands
can Indian/Alaska Native
Cumulative
Cumulative
Cumulative
Complative
1993
total
1003
total
1993
'otal
Exposure category
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
2
(%)
Injecting drug use
17
(18)
38
(16)
18
(33)
54
(47)
7.827
(47)
2: "se
(49)
Hemophiia/coagulation disorder
1
(1)
1
(0)
-
-
27
(0)
(0)
Heterosexual contact:
54
(56)
108
(45)
24
(44)
37
(32)
6.253
(37)
5 45
(35)
Sex with injecting drug user
17
35
14
24
2.833
4883
Sex with bisexual male
15
30
1
3
522
367
Sex with person with hemophilia
-
2
=
2
71
.89
Sex with transfusion recipient
with HIV infection
7
11
-
-
111
122
Sex with HIV-infected person.
risk not specified
15
30
is
8
2.716
: 558
Receipt of blood transfusion,
blood components. or tissue
13
(13)
59
(25)
3
(5)
9
(8)
529
( 2,
E
Risk not reported or identified
12
(12)
34
(14)
10
(18)
14
(12)
2,188
(13)
(10)
Total
97
(100)
240
(100)
50
(100)
114
(100)
16,824
(100)
48 25
(100)
'See Figure 7.
²Includes 77 women V. ose race/ethnicity is unknown.
HIV/AIDS Surveillance Report
10
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$
004-037
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HHS NAPO
Table 6. Pediatric AIDS cases by exposure category and race/ethnicity, reported
in 1993, and cumulative totals, through December 1993, United States
White, not Hispanic
Black, not Hispanic
Hispanic
Cumulative
Cumulative
Cumulative
1993
total
1993
total
1993
total
Exposure category.
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
Hemophilia/coagulation disorder
17
(11)
145
(14)
3
(1)
27
(1)
3
(1)
33
(3)
Mother with/at hak for HIV infection:
124
(83)
699
(68)
512
(96)
2,734
(95)
248
(94)
1 167
(91)
Injecting drug use
44
300
166
1.209
86
523
Sex with injecting drug user
23
136
72
413
52
340
Sex with bisexual male
4
38
3
29
4.
21
Sex with person with hemophilia
1
13
1
5
I
3
Sex with transfusion recipient
with HIV infection
-
5
1
6
1
1.
Sex with HIV-infected person.
risk not specified
14
55
03
224
33
86
Receipt of blood transfusion.
blood components, or tissue
6
32
12
58
7
26
Has HIV infection. risk not specified
32
111
195
789
65
160
Receipt of blood transfusion, blood
components, or tissue
$
(5)
108
(16)
6
(1)
74
(3)
8
3)
(5)
Risk not reported or identified
1
(1)
(1)
11
(2)
31
(1)
4
(2)
is
2
(1)
-
Total
150 (100)
1,021 (100)
532 (100)
2,866 (100)
263 (100)
1 289 (100)
Asian/Pacific Islander
American Indian/Alaska Native
Cumulative totals
Cumulative
Cumulative
Comulative
1993
total
1993
total
1993
total
Exposure category
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No
(%)
No.
(%)
Hemophilia/coagulation disorder
-
3 (13)
-
1
(6)
23
(2)
209
(4)
Mother with/at risk for HIV intection:
3 (60)
11
(48)
3 (100)
15 (94)
895
(93)
4 637
(89)
Injecting drug use
1
3
2
7
302
2056
Sex with injecting drug user
-
2
1
2
148
895
Sex with bisexual male
-
,
-
-
10
83
Sex with person with hemophilia
-
-
-
-
2
2?
Sex with transfusion recipient
with HIV infection
1
-
2
in
3
-
-
Sex with HIV-infected person.
risk not specified
!
2
-
2
112
Receipt of niooa transfusion.
clood components. or tissue
1
-
-
-
25
Has HIV infoction. risk not specified
/
3
I
4
294
68
Receipt of blood transfusion. blood
components, or tissue
2 (40)
9 (39,
-
-
24
(3)
329
(6)
Risk not reported or identified
-
-
-
17
(2)
53
(1)
-
Total
5 (100)
23 (100)
3 (100)
16 (100)
959 (100)
5 228 (100)
See Figure 7
²Includes 13 children whose race/ethnicity is unknown.
Vol. 5, No. 4
11
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HHS NAPO
1
005/037
Table 7. AIDS cases in adolescents and adults under age 25, by sex and exposure category
reported in 1992 and 1993, and cumulative totals through December 1993,
United States
13-19 years old
20-24 years old
Cumulative
1992
Cumulative
1993
total
1992
1993
total
Male exposure category
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
Men who have OCX with men
32
(33)
113
(29)
358
(33)
747
(66)
1.554
injecting drug use
59:
+
7.015
(64)
(4)
23
(6)
72
(7)
131
(12)
Men who have sex with men
345
(12)
1.39'
(13)
and inject drugs
:
(4)
10
(3)
47
Hemophilia/coagulation disorder
(1)
109
(10)
241
44
19,
(45)
196
209
11:
(48)
468
(44)
37
Hotcrosexual contact.
( 3)
174
15)
(6)
412
(4:
6
11
(3)
22
(2)
47
(4)
129
(5,
31:
3)
Sex with injecting drug user
2
5
11
10
Sex with person with nemophinia
45
1.18
-
-
-
-
Sex with transfusion recipient
-
:
with HIV infection
-
-
-
Sex with HIV-infected person.
7
2
;
risk not specified
$
6
11
27
78
155
Receipt of blood transfusion.
blood components. or tis-
4
(4)
1.9
(1)
45
Risk no: reported or identified
(4)
1
(0)
4
18
(4)
(1)
30
==
(8)
58
(3)
55
(5)
227
(8)
529
(5)
Male subtotal
OR
(100)
387
(100)
1.070
(100)
1.130
(100)
2.788
(100)
947
(100)
Female exposure category
Injecting drug use
9
(10)
19
(9)
99
(20)
118
(31)
Hemophilia/coagulation disorder
324
(29)
1034
(35)
-
:
(0)
5
(1)
1
Heterosexual contact:
(0)
5
(0)
36
(61)
(0)
120
(60)
254
(52)
210
(SC)
371
(51)
454
(49)
Sex with injecting drug user
21
47
139
124
Sex with bisexual male
275
845
-
10
15
12
Sex with person with hemophilia
38
134
1
1
6
3
10
Sex with transfusion recipient
25
with HIV infection
-
-
1
I
Sex with HIV-infected person,
2
€
risk not specified
14
os
93
72
246
431
Receipt of blood transfusion.
blood components. or tissue
at
(7)
13
(6)
44
Risk not reported or identified
(9)
10
(3)
19
(2)
10
(17)
35
(3)
48
(24)
82
(17)
39
(10)
204
(18)
530
13;
Female subtotal
59
(100)
201
(100)
484
(100)
378
(10C)
1.123
(100)
2943
100;
Total
157
588
1.554
1.508
3,911
12090
See Figure 7.
HIV/AIDS Surveillance Report
12
Vol. 5. No. 4
09/20/94
18:33
202 690 7560
HHS NAPO
006. 037
Table 8. AIDS cases by age at diagnosis and exposure category, reported through December
1993, United States
Men who have
Men who
sex with men
Hemophilia/
have sex
Injecting
and inject
cosguiation
1
leterosexual
with men
drug use
drugs
disorder
contact
Age at diagnosis (years)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
Under 5
-
-
-
11
(0)
-
5-12
-
-
-
190
(6)
-
13-19
358
(0)
171
(0)
47
(0)
473
(14)
276
(1)
20-24
7,015
(4)
2:425
(3)
1.209
(5)
422
(13)
1,745
(8)
25-29
31,195
(16)
10,472
(12)
4,696
(20)
484
(14)
4,418
(19)
30-34
46,384
(24)
21,325
(24)
6.703
(29)
463
(14)
5.148
(22)
35 30
41,654
(22)
24,294
(26)
5.556
(24)
391
(12)
4,048
(17)
40-44
29.530
(15)
16,221
(19)
2.998
(13)
289
(9)
2.665
(12)
45-49
17.041
(9)
6,989
(8)
1,300
(6)
222
(7)
1,705
(7)
50-54
9,725
(5)
3,051
(3)
508
(2)
117
(4)
1,182
(5)
55-59
5,472
(3)
1,424
(2)
223
(1)
83
(2)
813
(4)
60-54
2.850
(1)
573
(1)
77
(0)
85
(3)
558
(2)
65 or older
1,628
(1)
312
(0)
40
(0)
104
(3)
608
( 3)
Total
193,652
(100)
87,259
(100)
23,360
(100)
3.342
(100)
23,166
(100)
Mother
with/at risk
Other/risk
Receipt of
for HIV
not reported
transfusion
infection
or Identified¹
Total
Age at diagnosis (years)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
Under 5
147
(2)
4,027
(87)
36
(0)
4,221
(1)
5-12
182
(3)
610
(13)
17
(0)
1,007
(0)
13-19
89
(1)
-
140
(1)
1,554
(0)
20-24
166
(3)
-
909
(5)
13,890
(4)
25-29
434
(7)
-
2,894
(15)
54,593
(15)
30-34
587
(9)
-
3,947
(21)
84,557
(23)
35-39
612
(9)
-
3,375
(18)
79,930
(22)
40-44
577
(9)
-
2.591
(13)
51,871
(15)
45-49
466
(7)
-
1,756
(9)
30,279
(8)
50-54
501
(8)
-
1,296
(7)
16.380
(5)
55-59
539
(8)
-
959
(5)
9,513
(3)
60-64
664
(10)
-
639
(3)
5,446
(2)
65 or older
1,547
(24)
-
679
(4)
4,921
(1)
Total
6,510
(100)
4,627
(100)
19,238
(100)
361,164
(100)
'See Figure 7.
Totals include 2 persons whose age at diagnosis is unknown.
Vol. 5. No. 4
13
HIV/AIDS Surveillance Report
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18:34
202 690 7560
HHS NAPO
007 037
Table 9. AIDS cases by sex, age at diagnosis, and race/ethnicity, reported through Decembe
1993, United States
White, not
Black, not
Asian/Pacific
American Indian/
Maie
Hispanic
Hispanic
Hispanic
Islander
Alaska Native
Total¹
Age at diagnosis (years)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
Under 5
348
(0)
1.247
(1)
527
(1)
9
(0)
8
(1)
2,142
(1)
5-12
247
(0)
191
(0)
158
(0)
7
(0)
1
( 0)
605
( 0)
13-19
510
(0)
330
(0)
208
(0)
11
(1)
11
(2)
1.070
( 0)
20-24
5,096
(3)
3,582
(4)
2.142
(4)
79
( 4)
31
(4)
10,947
(3)
25-
21.694
(15)
12.901
(14)
3,437
(16)
280
(13)
142
(20)
46,530
(15)
30-34
39,628
(23)
20,371
(23)
12.593
(24)
461
(2:)
192
(28)
73.349
(23)
35-39
37.545
(22)
20,762
(23)
11,395
(22)
402
(21)
135
(19)
70,439
(22)
40-44
26,949
(16)
14,313
(16)
7,546
(15)
381
(18)
96
(14)
49,378
(16)
45-49
15.948
(9)
7,402
(8)
4.087
(8)
222
(10)
3S
(5)
27.743
(9)
50-54
8.541
(5)
4,065
(5)
2,164
(4)
110
(5)
22
(3)
14,926
( 5)
55-69
4.887
(3)
2,301
(3)
1,242
(2)
67
(3)
10
(1)
3,534
(3)
60 w4
2.865
(2)
1,237
(1)
649
(1)
24
(1)
10
(1)
4,791
(2)
65 or older
2,417
(1)
928
(1)
478
(1)
38
(2)
4
(1)
3.870
(1)
Male subtotal
169,675
(100)
89,630
(100)
51,627
(100)
2,151
(100)
697
(100)
314.325
(100)
Female
Age at diagnosis (years)
under 5
337
(3)
1,233
(5)
494
(5)
1
(0)
7
(6)
2.079
(4)
5-12
89
(1)
195
(1)
110
(1)
6
(?)
-
102
( 7)
13-19
104
(1)
300
(1)
77
(1)
1
(0)
1
(1)
484
(1)
20-24
724
(6)
1,508
(6)
679
(7)
15
(6)
13
(11)
2.943
(6)
25-29
2,031
(18)
4,181
(17)
1.794
(19)
23
(9)
24
(20)
8 063
(17)
30-34
2.635
(23)
6.094
(24)
2.374
(25)
49
(20)
35
(29)
11.208
(24)
35-39
2.043
(18)
5.531
(22)
1.838
(19)
41
(17)
15
(12)
3.490
(20)
40-44
1,195
(10)
3.147
(12)
1,091
(11)
40
(16)
11
(9)
5.493
(12)
45-49
658
(6)
1.314
(5)
532
(6)
20
(8)
6
(5)
2.536
( 5)
50-54
389
(3)
749
(3)
297
(3)
14
(6)
3
(2)
1.454
(3)
55-59
351
(3)
425
(2)
191
(2)
9
(4)
2
(2)
379
(2)
60-54
270
(2)
276
(1)
92
(1)
12
(5)
3
(2)
655
(1)
65 or older
650
(6)
283
(1)
100
(1)
16
(6)
1
(1)
1.051
(2)
Female subtotal
11.476
(100)
25,238
(100)
(100)
247
(100)
121
(100)
16 838
(100)
Total²
181,151
114,868
61,297
2.39B
818
301,104
Includes 545 males. 86 females. and 1 person of unknown sex whose race/ethnicity IS unknown.
Includes I male and 1 female whose age at diagnosis is unknown. and 1 person whose sex is unknown.
HIV/AIDS Surveillance Report
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Table 10. AIDS cases and annual rates per 100,000 population, by race/ethnicity, age group,
and sex, reported in 1993, United States
Adults/adolescents
Children
Males
Females
Total
<13 years
Total
Race/ethnicity
No.
Rate
No.
Rate
No.
Rate
No.
Rate
No.
Rate
White, not Hispanic
43.987
57.3
4,103
5.0
48,090
30.2
150
0.4
25.0
Black, not Hispanic
28,792
266.2
9,220
73.1
38,012
162.2
532
7.2
38.544
125.0
Hispanic
15.301
145.9
3,324
32.2
8,625
89.5
263
3.6
18,888
67.3
Asian/Pacific Islander
665
21.2
97
2.9
762
11.7
5
0.3
767
9.3
American Indian/Alaska Native
281
41.3
55
7.7
336
24.0
3
0.6
339
17.9
Total
1
80,165
07.5
16,824
15.4
105,990
50.1
959
1.9
106,949
40.8
Includes 171 persons whose race/ethnicity is unknown and 1 person whose sex is ипкпоwп.
Table 11. AIDS cases by year of diagnosis and definition category, diagnosed through
December 1993, United States
Period of diagnosis
Before
Cumulative
1990
1990
1991
1992
1993
total
Definition category
No.
(%)
No.
(%)
No.
(%)
No.
(%)
No.
(%)
(%)
Pre-1987 definition
115,248
(78)
29,245
(63)
30.892
(56)
29,717
(44)
13.020
(29)
:- 22
(60)
1987 definition
29,554
(20)
13.869
(30)
16,508
(30)
18,181
(27)
8,530
(19)
- 612
(34)
1993 definition
2,267
(2)
2,988
(6)
7,366
(13)
19,664
(29)
24,115
(53)
"6 400
16)
Pulmonary tuberculosis
465
407
853
1,402
1.055
is :82
Recurrent pneumonia
-
US
133
387
615
291
Invasive cervical cancer
23
11
26
54
40
154
Severe HIV related
immunosuppressior²
1,694
2,511
6,362
17,821
22,412
50.800
Total
147,069
(100)
46,102
(100)
54,766
(100)
67,562
(100)
45,665
(100)
JOT
164
(100)
'Persons who meet only "he 1993 AIDS surveillance case definition and whose date of diagnosis is before January 1993 were clagnosed retrospec-
lively. The sum of diagnoses listed for the four conditions under the 1993 definition du not equal the 1993 definition total because some 06 10.75 have
more than one diagnosis from the addod sonditions of pulmonary tuberculusis, recurrent pneumonia, and invasive cervical cancer
2 Defined infection. as CD4+ T-lymphocyte count of less than 200 cells/uL or 8 CD4+ percentage less than 14 in persons with laboratory comments on of HIV
Vol. 5, No. 4
15
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009.037
DONE August S, 1984
Review of Deaft PHS Document, "Recommendations on the Use of
Zidovudine to reduce HIV Transmission From Mother to Child" for
publication in MMWR".
A. BACKGROUND INFORMATION
Malernal/fetal transmission of HIV
*
Worldwide, it is estimated that 15,000 to 20,000 children,
110, women, and 1 million men are HIV infected but not yet
diagnosed with AIDS. Women are the fastest growing segment
of the AIDS population, with 93% of the children with HIV
under the age of 13 who contracted the disease from their
mother, perinatally.
*
In the U.S. serosurveys indicate that annually 7,000 HIV
infected women give birth. With a 20-30% transmission rate,
that adds up to 1,400 to 2,100 infected infants born each
year.
*
By 1995, the number of children of children that will be
orphaned by AIDS will be 24,600 under the age of 13, 21,000
between the ages of 13-17, and by the year 2000, that number
will rise to more than 80,000.
*
Preventing HIV transmission among women is ideal, yet new
infections still occur. Refraining from breast feeding
decreases the risk of mother to infant transmission in the
periods. post partum period, but not the pre- or intra-partum
*
Prevention of transmission of HIV to the fetus, in utero or
intrapartum was the intent of clinical trial 076. There is
the possibility of transmission before birth or in the birth
process when the child is exposed CO copious amounts of the
mother's blood and other body fluids which contain HIV.
ACTG- 076
*
In February, 1994, The National Institutes of Health
rcleased preliminary results of clinical trial ACTG-076.
This trial was designed to evaluate the efficacy, safety and
tolerance of zidovudine (ZDV; also known as AZT) for the
prevention of maternal-fetal transmission of HIV. This study
was conducted in 50 sites in the USA and 9 sites in France.
*
There were 477 women and 364 infants enrolled in the study
at the time of the analysis of the data presented. A total
of 421 infants have been born since the study began in 1991.
Of those, 364 infants had at least one culture result
available.
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The women involved in this study initiated ZDV treatment
between 14-34 weeks gestation, had received nc other
antiretroviral treatment during the pregnancy, had CD4 level
greater that 200 cells/mm3 and had no clinical indications
for ZDV therapy prior to the pregnancy.
Under this study, ZDV was given to HIV infected pregnant
women with limited or no prior history of antiretroviral
therapy. These women were between 14 to 34 weeks gestation.
Zidovidine was given during this period and continued
throughout pregnancy and the labor period. The infant was
given ZDV for six weeks following delivery. Other women
were given placebo regiments.
The results indicated a two-thirds reduction rate- 8.3%
when both mother and infant received ZDV, compared to a rate
of 25.5% among those who received a placebo.
Even though there was a significant reduction, transmission
of HIV occurred despite ZDV therapy in 13 out of 180
infants.
HHS/PHS TASK FORCE
*
The Task Force entitled, "The Public Health Service/Health
and Human Services Task Force on the Use of Zidovudine to
Prevent Perinatal HIV Transmission" has had its first
meeting on April 14, 1994. This panel convened to discuss
implications of ACTG 076 for the woman and child, specific
treatment guideline issues, testing and counseling
parameters and propose timelines for the development of
recommendations and policies.
Specifically, NIH would develop draft documents regarding
treatment issues and begin evaluation of how on-going
natural history studico of HIV infection in women and
children could provide information regarding long term
effects of this therapy. This document has been drafted and
is the subject of this meeting.
CDC would draft a document pertaining to counseling and
testing issues for pregnant women, outline issues regarding
long term follow up registry for those infants exposed to
TBA.
ZDV in utero, and also begin evaluation of how CDC funded
natural history studies could provide further information
regarding the impact of this therapy on women and children.
The status of this document is still under review.
There will be a period for public comment once this document
has been drafted.
*
HRSA is responsible for developing plans to implement the
counseling, testing and clinical care recommendations. The
ON GOINCON
r
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implementation of the clinical findings of 076 into broader
settings including Ryan White programs will require early
identification of HIV infected women. Status unknown at
present.
FDA would review their process of labeling indication
assessment or ZDV for use in pregnancy. FDA indicated that
Burroughs-Wellcome has submitted an application for new
labeling indication for pregnant women after gestational
period of 14 weeks for reduction of HIV transmission. Draft
of the response has been sent to them for comment. The ACTG
076 review, the treatment draft guidelines, B-W application
and response document will be presented to the FDA Antiviral
Advisory Committee meeting on July 28, 7994. During this
meeting there will also be discussions of possible Phase IV
monitoring of long term effects on mothers and infants that
may be required of the company. August 24, 1994 is absolute
target date for completion of this process.
August, 1994 is the target month for publication of the
recommendations from this task force.
ISSUES OF CONCERN:
Indications for pregnant women and her child - who may be
potentially infected (25%) and potentially unaffected (75%)
is confounding. Placement in follow up studles are
available for adolescent women and all infants, yet not for
the other mothers. Provision of care services for the
mothers and their children will require increased allocation
of funds for this population.
The women in the study are already infected with HIV and
will develop life threatening diseases, which will increase
the orphan population in this country. What policies are
being considered to help with the foster care and adoption
systems in this country. This will require additional
funding streams to assist the social services agencies with
placement and financial subsidy for these children.
What are the long term risks of ZDV exposure in utero and
early infancy to the children--those who may have become
infected and those who would not have been infected anyway?
What will the impact of ZDV use during pregnancy have on the
woman's ability to use the therapy when it becomes indicated
for her own health?
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What about the infected child's ability to use this therapy
when indicated for his/her own health?
ZDV Was given in several periods, ante-partum, intra-partum,
and post partum. There is no indication that if ZDV is
effective if administered in only one or two of these
periods. This is especially critical if the woman delivers
outside the clinical setting.
who will pay for these women to receive ZDV if they are
unable to afford this therapy? who will provide services
for the child?
In some communities there has been a push for policies
toward mandatory testing of all pregnant women without
regard for their rights, based on the need to "save the
babies". This does a disservice to the mother, father,
siblings and the baby who may not become infected anyway.
Counseling should be offered in all settings. The woman
should be allowed to make her own decision regarding her
future treatment options.
There were no significant short term effects to either the
mother or infant other than anemia in the infant which was
reversed shortly after treatment ended. The women will be
only be followed for 6 weeks after delivery and the
infants (both HTV+ and HIV-) followed up to 21 years after
perinatal exposure to ZDV.
Recommendations
More extensive research is needed to determine the long term
effects of ZDV therapy on the infants, some of whom do not
become infected with IIIV and those who do in spite of ZDV
therapy. Additional studies are indicated to determine the
efficacy and safety of ZDV therapy for the mother. The
impact on the health and the progression of HIV disease in
the mother needs to be considered in subsequent studies.
The implications of this study highlight the need to broaden
our outreach efforts to women of childbearing years to seek
HIV counseling and testing. Clinicians who provide services
to these women must be alerted to the need to counsel them
regarding the potential impact of ZDV therapy, benefits and
risks. IL is important to note that 8 out of every 100
babies in the study was HIV infected, even though the mother
and infant had received 2DV.
For women who participate in high risk behavior, ie.
injecting drugs and unprotected sex with someone whose HIV
status is unknown, 1t is imperative that they have access to
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adcquate counseling, testing and treatment regardless of
whether they are pregnant or not. The rights of the woman
to adequate treatment should not be abrogated to the rights
of the unborn child.
*
Evaluation of Title IV programs demonstrate remarkable
success in identifying HIV positive youth and women,
retaining them and their newborn infants in comprehensive
care and supporting them to participate in early medical
treatment. Barly identification and follow up care for HIV
exposed infants by Title IV programs reduces morbidity and
mortality through a coordinated, comprehensive medical,
social and ramily support programs.
This document by itself is only a portion of the
recommendations needed to fully make this therapy available
for the women and children it targets. The American College
of Obstetrics and Gynecology and the Academy of Pediatrics
is also reviewing the data in order to make treatment
decisions regarding this therapy. It is therefore, critical
that this document be approved for publication in order to
give heath care practicioners recommendations on the use of
ZDV for HIV infected pregnant women, keeping in mind that
CDC, HRSA, HCFA and FDA have crucial roles in the
implementation of these therapeutic guidelines.
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EXECUTIVE SUMMARY:ABSTRACT ACTG 075
A Phase III Randomized, Placebo-Controlled Trial to Evaluate the Efficacy,
Safety and Tolerance of Zidovudine (ZDV) for the Prevention of Maternal-Fetal
Transmission
BACKGROUND
Currently, there are approximately 10-20,000 HIV-infected children and
approximately 7,000 infants are born annually to IIIV-infected women in the
United States. It is estimated that by the year 2000, 10 million children
clobally will have been infected.
The vast majority of HIV-infccted infants and children acquire the virus by
maternal-infant transmission; either in utero, during labor and delivery, or
postpartum via breactfooding. In the developed world, antepartum and
intrapartum routes account for nearly all of the cases. The risk of maternal-
infant HIV transmission in preguant women has been associated with advanced
disease stage, low CD4+ lymphocyte count, and high viral burden.
Zidovudine (ZDV) has been demonstrated to be an effective treatment to
decrease viral burdeo and delay disease progression for HIV-infected adults
and children. An uncontrolled survey of some pregnant women treated with ZDV
for their own medical care revealed no significant untoward effect.
The risk of materhal-intant transmission of HIV theoretically could be reduced
by ZDV treatment of pregnant women. To test this hypothesis, in April, 1991,
a Phase III randomized, double-blind, placebo-controlled clinical trial (ACTG
076) was initiated to evaluate whether ZDV therapy could reduce the risk of
maternal-fetal transmission in HIV-infected pregnant women. An additional
study objective was to evaluate the safety of the ZDV regimen for mothers and
infants.
METHODS
Eligible patients were HIV-infected pregnant women (between 14 and 34 weeks
gestation) who had no antiretroviral treatment during the current 3 pregnancy,
had baseline CD4+ lymphocyte counts greater than 200 cells/mm, and had no
clinical indications for maternal antepartum ZDV therapy. The target sample
size was 748 women (636 fully assessable mother-infant pairs). This was
chosen 50 as to provide 80 percent power to dotoct a reduction in Line
probability of transmission to 20 percent for the ZDV group compared with 30
percent for the placebo group, using a two sided, alpha=0.05 test. Women were
stratified according to gestational age (14-26 weeks; >26 weeks) and
randomized to receive either ZDV or placcbo.
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ACTG 076
EXECUTIVE SUMMARY:ABSTRACT
The ZDV regimen consisted of antepartum ZDV (100 mg p.o. five times daily)
plus intrapartum ZDV (IV loading dose, 2 mg/kg, followed by continuous
intusion, 1 mg/kg/hr, until delivery) plus newborn ZDV (syrup, 2 mg/kg 8. 6 hr
for six weeks beginning 8-12 hours after birth). Pregnant women were seen
frequently during pregnancy, through delivery, and for six months postpartum,
and were carefully assessed for evidence of drug toxicity, HIV disease
progression, and fetal well-being. Infants were carefully monitored through
78 weeks of age for evidence of HIV infection and to assess safety. HIV
infection status was determined by viral culture from the infants at birth, 12
weeks, and 78 weeks of life, and samples were obtained for HIV serology at 72
and 78 weeks. A protocol modification added an additional culture at 24
weeks. Infants were defined as HIV infected for the primary analysic based on
one positive viral culture obtained from peripheral blood.
On February 17, 1994, the ACTG Data and Safety Monitoring Board (DSMB)
reviewed the interim analysis based on information in the database as of
December 20, 1993, and concluded that there was significant evidence of
treatment efficacy. On February 18, 1994, the rediatric AIDS Clinical Trials
Group Executive Committee approved the DSMB recommendations to: (1) discon-
tinue new patient enrollment, (2) offer open-label ZDV as per protocol regimen
to all individuals on the study; and (3) continue long term follow-up of all
infants participating in ACTC 07G to monitor for possible development of
unknown late effects of the study treatment.
RESULTS
Thirty-five NIAID sponsored sites, 15 NICHD sponsored sites, and nine centers
in France enrolled patients in ACTG 076. Four hundred seventy-seven women
were enrolled as of the December 20, 1993 data cut-off. The median age was 25
years (range, 15-43), the median CD4+ lymphocyte count was 550 cells/mm
(range, 200-1818), and 41 percent of women had CD4+ lymphocyte counts between
200 and 500 cells/mm. The median gestational age at entry was 26 weeks.
Maternal demographics revealed a predominantly minority population: only 19
percent were white/non-Hispanic.
Four hundred twenty-one babies have been born; 409 singletons and 6 sets of
twins. The median gestational age at delivery was 39 weeks (range, 27-43
weeks). Three sets of twins and 23 singletons were premature (<36 weeks
gestation). The median 1-minute Apgar score was 8 (range, 0-10), the median
5-minute Apgar was 9 (range, 5-10), and the median birth`weight was 3160 grams
(range, 1040-5267 grams). Seven infants (1.7 percent) weighed <1500 gramo at
birth, 14 (3.4 percent) weighed between 1500 and 2000 grams, and 44 (10.7
percent) weighed between 2000 and 2500 grams.
Three hundred sixty-four births WRTP included in this intorim officacy
analysis, 180 in the 2DV group and 184 in the placebo group. Two hundred
thirty-three infants had information about HIV infection status as of 24 weeks
016.037
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ACTG 076
EXECUTIVE SUMMARY -ARSTRACT
of life, and 75 of these had confirmation at 18 months. Thirteen babies in
the ZDV group and 40 in the placebo group were defined as HIV-infected. The
estimated percentages infected based on Kaplan-Meier analysis were 8.3 percent
(s .: 2.25 percent) in the ZDV group and 25.5 percent (s.e.: 3.60 percent)
in the placebo group. The estimated absolute difference in percentage
infected between the two groups was 17.2 percent, with 95 percent confidence
interval 8.9 to 25.5 percent. This corresponded to a 67.5 relative reduction
in transmission risk. This risk reduction is highly statistically significant
(z=4.03; two-sided p=0.000056).
Reported maternal and infant side effects were balanced between the two
randomized groups, with one exception that hemoglobin levels were lower for
infants in the ZDV group. The mean decrease in hemoglobin was less than 1
g/d1, did not require transfusion, and resolved after completion of ZDV
therapy.
CONCLUSIONS
A treatment regimen consisting of ZDV given to the mother both antepartum and
intrapartum, as well as to the newborn during the first six weeks of life,
significantly reduced the risk of maternal-infant transmi asion of HIV for
women with baseline CD4+ lymphocyte counts >200 cells/men. Further follow-up
of mothers and infants is being conducted to determine if there are any late
adverse effects of this treatment regimen. Any decision to institute therapy
regimens for the prevention of maternal-Fetal transmicsion must be made after
careful consideration of the potential unknown long term risks.
February 20, 1994
Distributed with Site Instructions
Prepared by:
Richard D. Gelber, Ph.D.
Pavel Kiselev, Ph.D.
Edward Connor, M.D.
Rhoda Sperling, M.D.
John Moye, M.D.
Mary Culnano, M.S., C.R.N.P.
Bethann Cunningham, M.S.
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PRINCIPLES FOR IMPLEMENTATION OF EXPANDED HIV COUNSELING AND
TESTING AND ACTG 076 FOR HRSA PROGRAMS
IIRSA Constituent Meeting, September 19-20, 1994
HRSA's Working Group on Prevention of Perinatal Transmission of HIV met in
Washington, D.C. on May 25, 1994 to initiate discussion of the impact of recently
announced findings of the ACTG 076 randomized clinical trial of Zidovudine (ZDV)
for the reduction of HIV transmission from infected mothers to their infants. As the
first of the two HRSA-sponsored meetings to address the clinical, psychosocial. ethical,
financial and legal implications of the study. the meeting hrought together women with
HIV, providers, advocates, ethicists, and policy makers to explore issues and concerns
in an open forum.
The following recommendations were made by this Working Group. These principles
form the basis for the discussions of implementation strategies for the September 19-
20, 1994 meeting.
Expanded HIV counseling and testing should be made available in all settings that
provide care to women. Existing programs serving women in high, medium and low
seroprevalence areas will need to plan and prioritize this service and other service
obligations depending on space, staff and financial resources. Testing should only be
performed after women give specific informed consent. Informed consent should
include a clear, simple presentation of the benefits of early intervention services to
woman (and infants, if applicable). Counselors should be aware of local resources
and services for women with HIV and arrange for ongoing care when positive
serostatus results are given.
Information on the risks and benefits of Zidovudine use during pregnancy (results of
076) should be made available to all pregnant women in clear, simple language to
enable women to make informed choices. PHS should develop a culturally sensitive
protocol for presenting the risks and benefits to women.
Providers of health care and services for women should make the 076 protocol
available to women who choose this option, either on sitc or by referral. It should be
clear to all women that their ongoing care will not be influenced by their decision.
The protocol is complicated; it requires coordination of care among primary care,
obstetric, hospital/delivery and pediatric health professional. This will not occur by
chance. It must be developed at the time the 076 protocol is initiated. Staffing,
equipment and supply requirements for all component need to be enunciated.
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All women and infants treated according to ACTG 076 protocol should receive long-
term follow up care. Infection status for all infants should be documented using
available technology. Results should be recorded in a standard database so outcomes
of the ACTC 076 protocol in community, as opposed to research, settings can be
documented.
Growth and development of infants with and without HIV infection should be
documented in longitudinal client databases. Long term clinical outcomes should be
documented for mothers including, where feasible, viral genotype and phenotype.
Implementation of recommendations regarding ACTG 076 will require substantial
community planning and education. Resources should he made available for
community planning to develop and coordinate appropriate services and follow-up
care for women and families. This will/could involve Medicaid, Medicare, DOD,
DVA, SAMSHA, CDC, state and locally funded providers and programs as well as
HRSA-funded ones.
Health care services for women need to be expanded including reproductive health,
substance abuse treatment and relapse prevention services.
Caregivers must be sensitive to the high level of distrust and tear that many
disenfranchised and minority populations have toward health care providers.
Culturally appropriate interventions and provider training must be developed to
increase trust, utilization of services and compliance with care.
Training should bc provided for health care workers on: 1) diagnosis and
management of HIV disease in women; and 2) counseling and testing for women
(issues such as cultural sensitivity; explanations/education for women in simple, clear
language: risks and benefits of AZT use during pregnancy; referrals to care and
support services and long term care need to be addressed). Without a significant
effort devoted to training hcalth professionals who provide care to women, expanded
availability of zidovudine for the reduction of perinatal transmission will not occur.
Policy discussion and planning should include representation of women with HIV.
Women with HIV should be considered an important source for community outreach
education, policy and planning.
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Focus Group on ACTG 076
Preliminary Report
Produced with support from the Maternal and Child Health Bureau through
Project # MCU PFC 031-01.
Institute for Family-Centered Care
5715 Bent Branch Road Bethesda, MD 20816 Phone: 301/320-2686 Fax 301/320-0048
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WE acknowledge the generosity of the momen who participated in the focus
group. By sharing their time, their experiences, and their perspectives they
have given us important insights about these complex issues. We thank
them.
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Preliminary Report
INTRODUCTION
The Institute for Family-Centered Care, with support from the Maternal and
Child Health Bureau, HRSA, U.S. Public Heal. Service, convened a group of 15
women from ten states to discuss issues related to ACTC 076. All of the
participants were HIV infected. The group included African-American,
Hispanic, and Caucasian women. Several of the women had histories of
substance abuse. The group included mothers of infected children. some of
whom had died; mothers of affected children; a woman who was pregnant; and
younger women who had not yet had children. In preparation for the meeting,
participants received written material about ACTG 076.
The day-long meeting was audio taped with permission from the participants.
In addition, three recorders kept notes during the meeting. M full report will be
developed within the next month for dissemination to policy makers, care
providers, and consumers. This report provides a brief summary of the main
themes and issues that were addressed at the meeting and presents
recommendations based on the discussion.
Overview of the day. The meeting began with a general description of the
clinical trial process and a presentation of the specific 076 research by Dr.
Marilyn Crain, the pediatric principal investigator for ACTG trials at the
University of Alabama at Birmingham and Director of the Family Clinic, a Ryan
White Title IV program, jointly sponsored by the University of Alabama,
Department of Pediatrics and the Children's Hospital of Alabama. Dr. Crain's
presentation was essential to the later discussion of issues related to 076.
Participants had ample time to ask questions and to express their concerns about
both the design of the specific trial and clinical trials in general. The opportunity
to receive thorough, unbia ed information from a physician who had
participated in the study enabled participants to develop a clear understanding
of the actual research and also fostered a sense of trust, respect, and candor
within the group.
It should be noted that several of the women initially stated they were opposed
to AZT treatment of any kind. This is extremely important because it reflects the
anti-AZT bias that exists in many communities. After talking with the other
participants and Dr. Crain over the course of the day, however, these women
seemed willing to evaluate the 076 treatment with a more open mind. This
highlights how critically important it is to ensure that women have
opportunities to receive accurate information in an unhurried, supportive
atmosphere. Not only does it enhance their ability to make informed choices for
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themselves and their children, it also fosters more collaborative, trusting
relationships with providers.
After Dr. Crain's presentation, a structured focus group was conducted.
Participants were asked the following questions:
Focus Group Questions
1. Given Dr. Crain's overview of the ACTG 076 research and results, what
issues or questions come to mind?
- What questions might you and other women have when deciding if you
would take the kind of treatment described by Dr. Crain?
2. Who do you think should receive information about the results of 076?
- What kind of information should be given?
- Who should present the information and how should they present it, so
that women will fully understand the implications for themselves and their
infants?
- Are there special considerations in informing teen-age girls and younger
women about the results of 076?
3. Please describe what you think would be the ideal setting and approach to
HIV counseling and testing for women.
- Are there special considerations in providing counseling and testing to
teen-age girls and younger women?
4. If a woman is tested and finds she is HIV positive, please describe what
counseling, treatments, services, and other supports should be available to
her.
5. This focus group has helped us learn about your perspectives on ACTG 076.
What other methods could be used to gather information on these issues
from a broad group of women ?
At the end of the day, participants voted their tesponses by secret ballot to the
following four questions:
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Should all pregnant women be offered testing, after appropriate pre-test
counseling with post-test support, regardless of perceived HIV risk?
Should there be mandatory testing of all pregnant women?
Should there be mandatory testing of all women ages 13-50?
Should HIV infected pregnant women be required to take the 076 treatment?
The full report of the focus group will include a summary of the participants'
responses to all of the questions. What is presented here is a discussion of the
main themes and issues that emerged during the day, their implications for the
implementation of ACTG 076, and a brief set of recommendations based on the
women's observations, perspectives, and experiences.
ISSUES AND IMPLICATIONS
Women's Attitudes About Health Care Providers and the Health Care
System. An overriding theme of the meeting was the participants' pervasive
mistrust of health care providers, both within the research community and
within the care system. The women expressed a profound degree of suspicion
about AZT and about the design of the 076 study, as well as a deep mistrust
about how the 076 findings might be implemented. As one woman said, "When
the report came out it scared me, because I know the doctors will now be ready
to make recommendations about how to treat all women." Another said, "Now
women who are infected will be pressured to take AZT, just as they have been
pressured to have abortions." Yet another expressed her concern this way,
"What is the 'snowball' effect of this one trial? Will women who won't
participate be found 'unfit'- will it be used to blackmail women?" This wariness
and skepticism about providers' attitudes toward HIV infected women was
prevalent throughout the discussion.
Among the specific questions that were raised about the 076 findings were.
What are the long term effects of AZT on the babies in the study?
What about the design of the study - "If you change any part of the puzzle,
does it change the results?"
Is there any follow-up care for the women? Are there any follow up studies
on the women?
If women participate in 076 treatment will they jeopardize a later
opportunity to take AZT when their own health might benefit from it?
Will the treatment work for more than one pregnancy?
Why is there such a great hurry to implement 076 treatment when there are
still so many unanswered questions?
Can a woman trust her health provider to have the woman's best interest in
mind when making recommendations?
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If it turns out that AZT really works will it be made available to all women?
Who will pay for it?
A number of the participants stated that the 076 study pitted their rights as
women against the rights of their babies. One woman described the difficult
choice 076 presents to women this way, "It's very important to me that my child
not be born with this virus, but I also have to think about if I want to have a
child and then not be around to be there for the child. Do I want to have a baby
and then ? year after taking AZT my immune system shuts down and I die
within the year, and then not be able to be there for my child?"
Others expressed anger at being considered "vessels." One woman poignantly
said, "It seems that women - as real, thinking, responsible, contributing adults
- were overlooked." Another said, "It seems like in the whole study women
were ignored." However, participants also pointed out that if providers
continued to ignore the rights and concerns of women they and their babies
would be lost to treatment. "Unless you're going to strap us down, you need our
cooperation. If you don't care about me, I don't care about you. You need to be
partners with women in order to get this care tu the baby." Another Pas depant
added, "If you don't take care of the mother, she won't be there in the future for
the baby."
Many of the women, especially those with a history of substance abuse,
expressed concern that women will be coerced into agreeing to the 076
treatment. A number of the women said they were fearful that refusal to take
AZT could result in a referral to child protective services. There was real
concern that 076 might be used as a way to take their children away.
Finally, the participants expressed concern about how information about 076
will be conveyed to women. These concerns again stemmed from the women's
suspicions of providers - that providers would not give complete or accurate
information, that they would not provide information in ways that women
could understand, and that they would not support women in making
informed choices for themselves.
Implications: It is clear that many of the participants in the focus
group feel powerless and undervalued by the medical community.
They describe having limited input in decisions affecting their own
care and no input in policy and program decisions affecting
women's health care in general. The resulting mistrust of providers
has major implications for the acceptance of the ACTG 076 findings
by HIV infected women. It is incumbent upon health care providers
to establish trusting relationships with these women, to develop
forums where information can be shared, and to provide the
necessary practical and emotional supports for women to make
informed decisions about their treatment options.
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information and Informed Decision-Making. Although the participants
had concerns and questions about the 076 research, there was strong agreement
that information about the trial and its results should be made widely available.
In response to a question about who should receive information about C76, the
women said: "women, women, women"; all HIV positive women; all women
of childbearing age; all women: OB/GYNs: pediatricians; male partners;
women's families and other supports; the ACLU; community-based
organizations; the media; anyone connected with family planning: adolescents;
and Boards of Education.
Similarly, when asked what kind of information should be made available, the
women said, "Every little thing that is known." They urged that complete
information about the study - - the specific results as well as the unanswered
questions - be given to women in understandable terms. They emphasized that
both the pros and the cons of the treatment must be presented, and that the
main facts of the study should be presented with neutrality and clarity.
Participants pointed out that the way the information is presented is as
important as what is presented. They urged that information be offered in
understandable terms, in many languages, by people women can relate to, and
in places where women typically get and exchange information (markets,
churches, schools). Some suggested a national media campaign, others an 800
number that women could call to get information on 076 (perhaps as part of the
existing 1-800-TRIALS-A hotline).
There was agreement in the group that the information will have the greatest
impact if it is separated from HIV, and presented as part of women's health care
in general. Several women said that information about 076 would be
overwhelming if given as part of HIV counseling and testing - "You can't
concentrate on the diagnosis of HIV and this information at the same time.
(see section on counseling and testing for additional comments).
The participants were unanimous in the belief that every woman should have
the right to decide for herself about the 076 treatment. They voted 15 - O against
mandatory 076 treatment for HIV infected pregnant women. They urged health
care providers to give women complete, comprehensible information about 076
and then to support them in making their own decision regarding treatment.
They recommended that consent forms be carefully developed in collaboration
with women who are HIV infected and be written in understandable ways.
The participants cautioned that the power dynamics between providers and
women - especially younger women, women who do not speak English, and
women with a history of substance abuse - make it very difficult for women to
make their own decisions. In addition, they warned that women who put "blind
trust" in health care providers may have their rights to informed decision
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making "greatly compromised." Providers, they said, must take responsibility
for presenting the pros and the cons of the 076 study. One participant said,
"Many women aren't going to think it through. They're going to reach out for
hope. We already feel guilty, and we'll be made to feel even more guilty for not
taking AZT. The doctors must give 118 the information about both the risks and
the benefits."
The participants' ardent belief in a woman's right to make decisions about her
own treatment is reflected in the statements they wrote when asked, "If you
could tell policy makers one thing related to 076, what would it be?"
Among their responses were the following:
"Give the public education on 076. Let the women make the final
decision."
"As an HIV infected woman, I feel that 076 and its results are very
overwhelming, but at the same time I feel it is too inconclusive. Please
leave this choice to me. Educate me and help me to make an educated
decision."
"All HIV infected pregnant women should be fully informed on the
results of the 076 study and given the option of taking AZT during their
pregnancy."
"Give all women the understanding and the choice to decide."
"Please recognize me as a human being, who wants to make the right
decision based on my needs, wants, abilities, and freedom of choice. I am
not a vessel, I am not a disease, I am not an "undesirable." I have
strengths, abilities, desires, and rights. Let me love, help me to grow and be
as productive as possible, for as long as possible. Acknowledge and respect
me, we both lose when you ignore or dismiss me. Thank you for
listening."
Implications: It is essential that information about ACTG 076 be
widely disseminated and presented in an accessible, unbiased form.
Because of the mistrust that many women have of the health care
system, it will be especially important to build in ample time and
opportunities for women who are HIV infected to learn about 076,
to express their concerns, and to have their questions answered.
Women must be supported in the decisions they make about the
076 treatment. Any suggestion of mandated 076 treatment will drive
women away from the care system.
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Counseling and Testing. The participants provided a wealth of information
about counseling and testing. Their stories provided powerful testimony about
the devastation of receiving a positive test result. After learning her diagnosis,
one woman said, "I found out and I don't remember driving home that day."
Another said, "I wanted to kill myself." And another, "I learned I was positive
and I ran away for four years." Still another spoke of relapsing upon learning
the diagnosis and using crack for another year and a half before returning to the
care system.
These stories point out how critical a supportive counseling and testing system
can be in linking women to comprehensive care. Unfortunately, however, the
storics the women told of receiving their test results were largely negative. "I
was tested in a private doctor's office. I heard the results over the phone at work.
It's been over a year and I'm still waiting to hear from him again." Another
woman described her experience this way, "When I came back for the results no
one spoke to me, they just walked me down a long hall deep in the basement. I
knew something wasn't right."
These stories demonstrate that in many instances current approaches to
counseling and testing are not working well and, in fact, often drive women
away from the system instead of bringing them in during this highly stressful
time. These stories also point out that the time of diagnosis, even if handled in
the most supportive manner, is a very difficult time to have to make complex
decisions (e.g. about 076 treatment) - "You're asking the brain to be clear at a
time when it can't."
Approaches to counseling and testing for women must be improved. The
participants in the focus group provided eloquent descriptions of how the
testing process could be more humane and supportive. Their comments again
reflected their desire to be treated respectfully by providers and to have their
psychosocial and emotional needs acknowledged and supported. Among the
specifics offered by the women in the focus group were:
Provide testing in sites where women get other health care services.
The testing site should be pretty, bright, and cheerful.
The people who are doing the testing should be women. They should come
from the same community and speak the same language as the people being
tested. They should be warm, caring, and non-judgmental.
HIV positive women should be available for support when the test results
are given.
Because teens learn and relate differently, peer counselors should be used.
Both the pre-test and post-test session should be at least two hours. There
should be an interim meeting during the time the woman is waiting for the
results to build rapport and continuity and ensure support.
Give important information about care and support during pre-test phase
since some women don't return for post-test follow up.
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Use the time between the pre and post test meetings to educate people. Offer
an interim educational scssion on HIV.
Give information about resources, care, and support at the time of diagnosis.
Make sure people doing testing have been properly trained.
Testing sites must be linked to services - "If you can't treat, you shouldn't
test."
Provide a psychosocial assessment and several counseling sessions prior to
testing to determine if woman will be able to handle positive results.
Link mental health services, substance abuse treatment, and peer support to
counseling and testing.
Provide a range of test sites, from regular health clinics to anonymous test
sites.
There should be a stronger link between HIV education and prevention
efforts and testing.
If the woman tests negative, take the opportunity to reinforce -ink reduction
education - "Some people think if they test negative once, they'll always be
negative -- like an immunization."
Shorten time between having blood drawn and getting results - "We have
one hour service for photographs, why not one hour service for an HIV
test?"
Women need to be there for other women during the testing process -
"We're all family."
Implicit in all the suggestions about an ideal counseling and testing system was
the need for psychological support and an immediate connection to a care
system. Participants stressed that special care must be taken with younger
women and adolescents who are especially vulnerable and who may have very
few social supports. HIV education and information about testing for teens
should be provided by young people in the community.
The women also stressed that more public education about HIV was needed to
reduce the stigma around HIV. With less stigma, more women would come for
testing. One participant's comment reflects the degree of stigma still associated
with HIV, "It's better to go out as a drug addict than as an HIV positive woman
There's more acceptance in society of drug abuse."
Finally, in response to three questions about universally offered/mandated
testing for women the participants answered:
Should all pregnant women be offered testing, after appropriate pre-test
counseling with post-test support, regardless of perceived HIV risk?
Yes - 13
No 2
Should there be mandatory testing of all pregnant women?
Yes - 4
No - 11
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Should there be mandatory testing of all women 13-50?
Yes 3
No - 12
Implications: Because of the overwhelming emotional impact of
receiving a positive test result, many of the participants felt it would
be extremely difficult to make an informed choice about the 076
treatment at that time. Therefore, opportunities for testing must be
made more available to women during routine health care
encounters and as part of pre-conception care. In addition, the
testing process needs to be humanized, and the psychosocial aspects
of receiving a positive diagnosis must be comprehensively
addressed.
CONCLUSIONS AND RECOMMENDATIONS
The focus group provided a tremendous am
formation
men's
opinions about ACTG 076 and related issues including information
dissemination, counseling and testing, and the components of a comprehensive
care system for women with HIV infection. The participants' perspectives and
comments provide important guidance on how information about 076 can be
effectively communicated and how women can and should be supported in
making care and treatment decisions for themselves and their children.
The following recommendations are based on the information, concerns, and
experiences shared by the women in the focus group discussion.
There is a high degree of suspicion among women about the medical
community and about the efficacy of anturetroviral treatments. As a result,
policy makers and clinicians must allow ample time for women to become
informed about the study and ensure that there are opportunities for them
to discuss their concerns. Without this kind of supportive, educational
framework, many women will not consider the 076 treatment.
All women have a fundamental right to complete, unbiased information
about 076 so they can make a fully informed decision about accepting or
declining treatment. No woman should ever be explicitly or implicitly
coerced into treatment.
The devastating impact of a positive HIV test result can potentially
compromise a pregnant woman's ability to make an informed decision about
076 treatment. Therefore, there must be increased efforts to offer supportive,
appropriate HIV testing to women as part of general health care and during
preconception care.
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Because of the enormous emotional burden of receiving an HIV diagnosis,
all HIV counseling and testing for women must be linked to mental health
services, peer support, substance abuse services, and comprehensive health
care. Without these kinds of supports women will be lost to care and
treatment.
Too often, women (and other consumers) have been excluded from
participation in the health care decisions that affect their lives. In the future,
these consumers must be at the table when all research and clinical decisions
are being made. This kind of collaboration will foster trusi between the
recipients of care and the providers of care and ensure that decisions are
made in the best interest of those living with HIV.
While the information in this report pertains primarily to the ACTG 076, the
observations and experiences of the women reflect problems in the overall
health care system. Their very powerful commentary about the lack of trust they
have in providers and in the health care system goes far beyond HIV and AIDS.
Similar!-- their clear, well-articulated vision of how the care system could be
restructured to be more respectful and more responsive to the needs of women,
children, and families applies to all settings where health care is delivered.
One participant in the focus group said, "When making policy choices, you
must include HIV positive women and adolescents in the entire decision
making process, from beginning to end." By incorporating her perspectives and
experiences, and the perspectives and experiences of other women in policy and
program development, the system of care will be improved. The principles of
collaborative planning and decision making are essential to designing an
effective, humane health care system, in HIV care and in care for all the nation's
citizens.
For copies of the full report, contact: Institute for Family-Centered Care, 5715 Bent Branch
Road, Bethesda, MD 20816, (301)320-2686.
The Institute for Family-Centered Care provides essential leadership on family-
centered issues. It serves as a central resource for policy makers, program planners,
direct service providers, design professionals and family members. The Institute
seeks to increase understanding and practice of family-centered care through
resource development, information dissemination, policy and research initiatives,
training, and technical assistance.
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CDC
August 5
MMWR
Recommendations
and
Reports
MORBIDITY AND MORTALITY WEEKLY REPORT
Recommendations of the
U.S. Public Health Service Task Force
on the Use of Zidovudine to Reduce
Perinatal Transmission of
Human Immunodeficiency Virus
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Centers for Disease Control
and Prevention (CDC)
Atlanta, Georgia 30333
032.037
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Vol. 43 / No. RR-11
the MMWA series of publications is published by the Epidomiology Program Office,
Centers for Disease Control and Prevention (CDC), Public Health Service. U.S. Depart-
ment of Health and Human Services. Atlanta. GA 30333.
Introduction
Background
SUGGESTED CITATION
General Principles I
Centers for Disease Control and Prevention. Recommendations for the use of zi-
Clinical Situations 2
rioviding to reduce perinatal transmission of num- immunodeficiency virus.
Perinatal Transm
MMWR 1994:43(No. RR-11): (inclusive page numbers).
Recommendations
and Infants
Centers for Disease Control and Prevention
David Satcher, M.D., Ph.D.
Potential 1 ong-Term
Director
and Recommend
James W. Currer M.D., M PH.
Conclusion
Associate Director for HIV/AIDS
The production of this report as an MMWR serial publication was coordinated in:
Epidemiology Program Office
Stephen B. Thacker, M.D., M.Sc.
Director
Richard A. Goodmen, M.D., M.P.H.
Editor, MMWR Series
Scientific Information and Communications Program
Recommendations ano Reports
Suzanne M: Hewitt. M.P.A.
Managing Editor
Ave W. Navin, M.A.
Project Editor
Rachel J. Wilson
Writer-Editor
Peter M. Jenkins
Visual Information Specialist
Single copies of this C
and Prevention, Nation
These recommendations do not represent approval by the Food and Drug Admini-
telephone: (800) 168 5
stration (FDA) or approved aboling for the particular product or indications in
question.
Copies can be purcha
USU of trade names is for identification only and does not imply endorseme. by
Printing Office. Washi
the Public Health Service or the U.S. Department of Health and Human Services.
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Vol. 43 / No. RR-11
MMWR
i
temiology Program Cffice
Contents
Hoalth Service, U.S. Depart
Introduction
1
Background
2
General Principles Regarding Treatment Record indations
6
dations for the use of zi-
Clinical Situations and Recommendations for Use of ZDV to Reduce
mmunadeficiency virus.
Perinatal Transmission
7
Recommendations for Monitoring the ZDV Regimen for Mothers
and Infonts
13
David Satcher, M.D., Ph.D.
Potential Long-Term Effects of ZDV Therapy for Mothers and Infants
Director
and Recommendations for tollow-Up
14
nes W. Curran, M.D., M.P.H.
Conclusion
15
ciote Director for HIV/AIDS
on was coordinated in.
en B. Thacker, M.D., M.Sc.
Director
4. Goodman, M.D., M.P.H.
Editor, MMWR Series
Suzanne M. Hewitt, M.P.A.
Managing Editor
Ava W. Navin, M.A.
Project Editor
Rachel J. Wilson
Writer-Editor
Peter M. Jenkins
ual Information Specialist
Single copies of this document are available from the Centers for Disease Control
and Prevention, National AIDS Clearinghouse, P.O. Box 6003, Rockville, MD 20660:
Food and Drug Admini-
telephone: (800) 458-5321.
reduct or indications in
Copies can be purchased from Superintendent of Documents, U.S. Government
1 imply endorsement by
Printing Office, Washington, DC 20402-9325; telephone: (202) 783-3238.
and Human Services.
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ii
MMWR
August 5, 1994
Vol. 43 / No. RR-11
Executive Committee and
U.S. Public Health Service Task Force
Mary A. Young, M n
Georgetown University
On June 6, 1994, the U.S. Public Health Service convened a workshop in Bethesda,
Washington, DC
Maryland, to dovelop recommendations for the use of zidovudine to reduce the risk
for perinatal transmission of human mn.unodeficiency virus (HIV). The recent results
of AIDS Clinical Trials Group Protocol 076, a con' ,lled clinical trial sponsored by the
National Institutes of Health in collaboration with the National Institute of Health and
U.S. Public 1
To Reduce Peri
Medical Research and the National Agency of Research on AIDS in France, indicate
that zidovudine administered to a selected group of HIV-inlected women and their
Lynne M. Mofenson, M
infants can reduce the risk for perinatal transmission of HIV by approximately two-
National Institutes of H
thirds. The implications of these results for use of zidovudine in HIV-Infected pregnant
Bethesda, MD
women and neonates were discussed AT the washshop. The following persons partici-
pated in the workshop and either served as the Executive Committee writing group
James Balsley, M.D., Pf
that developed the recommendations or were members of the U.S. Public Health
National Institutes of Hi.
Service lask Force on the Use of Zidovudine to Reduce Perinatal HIV Transmission.
Bethesda, MD
Executive Committee
Patricia S. Fieming
Office of the Secretary
Howard L. Minkoff, M.D. (co-chair)
Wade Parko, M.D. (co-chair)
U.S Department of Hoc.
State University of New York
New York University School of
Human Services
Brooklyn, NY
Medicine
Washington. DC
New York, NY
Arlene D. Bardeguez, M.D.
Helene D. Gayle, M.D., 1
New Jersey Medical School
Paul Meler, Ph.D.
Centers for Disease Cor
Newark, NJ
Columbia University
and Prevention
New York, NY
Wachington, DC
Yvonne J. Bryson, M.D.
University of California at Los Angeles
Angus Nicoll, M.D.
Steven Gitterman, M.D.,
Los Angeles, CA
Comm unicable Dise- veillance
Food and Drug Adm. his
Centre
Rockville, MD
Isaac Delke. M.D.
University of Florida College of
London, England
Medicine
Mary J O'Sullivan, M.D.
Jacksonville, FL
University of Mlami
Miami, FL
Clementc Diaz, M.D.
University of Puerto Rico
Sallie M. Perryman
School of Medicine
New York State Department of Health
San Juan, PR
New York, NY
Joep M.A. Lange, M.D.
Gwendolyn B. Scott, M.D.
World Health Organization
University of Miami School of Medicine
Geneva, Switzerland
Miami, FL
Michael K. Lindsay, M.D., M.P.H.
Diane 11. Wara, M D.
Emory University
University of California at
Allenta GA
San Francisco
San Francisco, CA
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August 5, 1994
Vol. 43 / No. RR-11
MMWR
ill
e and
Executive Committee (Continued)
Task Force
Mary A. Young, M.D.
Curmen D, Zorrilla, MD.
Georgetown University Medical Center
University of Puerto Rico
ened a workshop in Bethesda,
Washington, DC
School of Medicine
zidovudine to reduce the risk
San Juan, FR
viru- "IV). The recent results
clinical trial sponsored hv the
U.S. Public Health Service Task Force on the Use of Zidovudine
lational Institute of Health and
n on AIDS in France. mulcate
To Reduce Perinatal Transmission of Human Immunodeficiency Virus
IIV-infected women and their
Lynne M. Motenson, M.D. (chair)
David Lanier, M.D.
of HIV by approximately two-
National Institutes of Health
Agancy for Health Care Pulicy
udine in HIV-infacted pregnant
Bothesda, MD
and Research
The funuwing persons partici-
*ive Committee writing group
James Balsley, M.D., Ph.D.
Rockville. MD
are of the U.S. Public Health
National Institutes of Health
Frances E. Page, B.S.N., M.P.H.
Perinatal HIV Transmission.
Bethesda, MD
Office of National AIUS Policy
Patricia S. Flaming
Washington, DC
Office of the Secretary
Marths F. Roger M.D.
S, M.D. (co-chair)
U.S. Department of He and
Centers for Disease Control
School of
Human Services
and Prevention
&
Washington, DC
Atlanta, GA
NY
Helenc D. Gayle, M.D., M.P.H.
Patricia Salomon, M.D.
Ph.D.
Centers for Disease Control
Health Resources and Services
and Prevention
University
Administration
NY
Washington, DC
Rockville, MD
all, M.D.
Steven Gitterman, M.D., Ph.D.
able Disease Surveillance
Food and Drug Administration
Rockville, MD
igland
Sullivan, M.D.
of Miami
arryman
State Department of Health
NY
B. Scott, M.D.
of Miami School of Medicine
ara, M.D.
of California at
:isco
CO, CA
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August 5. 1954
Vol. 43 / No. RR-11
MMWR
19
significance of zidovudine resist
is. J Pedietr 1993:123:1-8.
BOX 3. Summary: Clinical situations and ecummendations for use of zidovudine*
resistance, syncytium-inducing pho-
to reduce perinatal HIV ansmission
tudy. J Acquir Immune Defic Syndr
iiscontinuation of zidovudine treat-
1. Pregnant HIV-infected women with CD4+ T-lymphocyte counts >200/pL
ency virus type 1 isolates. Antimierob
who are at 14 34 weeks of gestation and who have no clinical indications
lime in late pregnancy and labour. J
for ZDV and no history of extensive [>6 months) prior antiretroviral therapy.
Recommendation:
onal exposures to bloodborne patho-
munodaficiency virus. Clin Infect Dis
The health-care provider should recommend the full ACTG Protocol 076
regimen to all HIV-intected pregnant women in this category. This recorn-
phylaxis with zidovudine suppresses
mendation should be presented to the pregnant woman in the context of a
is mice in a time-dependent manner
risk-benefit discussion: a reduced risk of transmission can be expected, but
the long-term adverse consequences of the regimen are not known. The de-
idovudine therapy prevents disease
Immune Defic Syndr 1991;4:506-12.
cision about this regimen should be made by the after discussion
Prophylactic ZDV therapy prevents
with her health care provider.
nfection in feline immunodeficiency
13;6:127-34.
IL Pregnam HIV-infected women who are at >34 weeks of gestation. who
H. Suppression of HIV-infection in
have no history of extensive (>6 months) prior antiretroviral therapy. and
who do not require ZDV for their own health.
infection and zidovudine use among
IIV-infected blood. Ann Intern Med
Recommendation:
The health-care provider should recommend the full ACTG Protocol 076
management of early HIV infection.
94-0572. Rockville. MD: Agency for
regimen in the context of a risk-henefit discussion with the pregnant
IS Department of Health and Human
woman. The woman should be informed that ZDV therapy may be less ef-
fective than that observed in ACTG Protocol 076. because the regimen is
trie UIV Resource Center. Antiratiovi-
being initiated late in the third trimester.
munodeficiency virus-infected child.
III. Pregnant HIV-infeeted women with CD4+ T-lymphocyte counts <200/uL
rinii pneumonia for children infected
who are at 14-34 weeks of gestation, who have no other olinical Indications
Vo. RR-2).
(elines. MMWR 1993;42 (No. RR-14).
for ZDV. and who have no history of extensive (:-0 months) prior and-
strategy for intervention to reduce
retroviral therapy.
:101:192-6.
Recommendation:
The health-care provider should recommend initiation of antenatal ZDV
therapy to the woman for her own health benefit. the intrapartum and neo-
notal components of the ACTG Protocol 076 regimen should be
recommended until further information becomes available This recom-
mendation should be presented in the context of a risk-benefit discussion
with the pregnant woman.
IV. Pregnant HIV-infected women who have a history of extensive (>6 months)
ZDV therapy and or other antiretroviral therapy before pregnancy.
Recommendation:
Because data are insufficient to extrapolate the potential efficacy of the
ACTG Protocol 076 regimen for this population of woman, the health-care
provider should consider recommending the ACTG Protocol 076 regimen
These rccommendations du not represent approval by the rood and Drug Administration
(FDA) or approved labeling for the particular product or indications in question.
09/20/94
18:53
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HHS NAPO
037/037
20
MMWR
August 5, 1994
BOX 3. Summary: Clinical situations and recommendations for use of zidovudine
to reduce perinatal HIV transmission (Continued)
on 8 case-by-case basis after a discussion of the risks and benefits with the
pregnant woman. Issues to be discussed include her clinical and immu-
nologic stability on ZDV therapy, the likelihood she is infected with a
ZDV-resistant HIV strain, and, if relevant, tt reasons for her current HRA of
an siternative antiretroviral agent (e.g., lack of response to or intolerance of
ZDV therapy). Consultation with experts in HIV infection r BY be warranted.
The health-care provider should make the ACTG Protocol 076 regimen avail-
able to the woman, although its effectiveness may vary depending on her
clinical status.
V. Pregnant HIV-infected women who have not received antepartum anti
retroviral therapy and who are in labor.
Recommendation:
For women with HIV infection who are in labor and who have not received
the antepartum component of the ACTG Protocol 076 regimen (either be-
cause of lack of prenatal care or because they did not wish to receive
antepartum therapy). the health-care provider should discuss the benefits
and potential risks of the intrapartum and neonatal components of the
ACTG Protocol 076 regimen and offer ZDV therapy when the clinical citu
ation permits.
VI. Infants who are born to HIV-infected women who have received no intra-
partum ZDV therapy.
Recommendation:
If the clinical situation permits and if ZDV therapy can be inniated within 24
hours of birth, he health-care provider should offer the ACTG Protocol 076
postpartum component of 6 weeks of neonatal ZDV therapy for the infant in
the context of a risk-benefit discussion with the mother. Data from animal
prophylaxic otudica indicate that, if ZDV is administered, therapy should be
initiated as soon as possible within hours) after delivery. If therapy cannot
begin until the infant is x21 hours of ago and the mother did not receive
therapy during labor, no data support offering therapy to the infant.