New awards, expanded focus for Pediatric AIDS Clinical Trials Group

The National Institute of Allergy and Infectious Diseases (NIAID) today announced $36 million in renewed funding for the Pediatric AIDS Clinical Trials Group (PACTG), and a greater focus on both adolescent research and international pediatric research. The new five-year awards will support 18 university-based clinical trials sites, a statistical and data management center, and a coordinating and operations center.

The PACTG has pioneered key trials evaluating treatments for children with HIV and has made great advances in reducing the rate of mother-to-infant HIV transmission in the developed world. The epidemic among adolescents in the United States, however, has become an increasing concern. The Centers for Disease Control and Prevention reports that 4,219 cumulative cases of AIDS among adolescents, or children ages 13 through 19, were reported through June 2001,(1) and the number of adolescents living with HIV is estimated to be much higher.

Because the average length of time between HIV infection and the development of AIDS is 10 years, it is believed that many adults became infected as adolescents. Most adolescents infected with HIV are at an early stage of disease and are ideal candidates for early intervention and treatment strategies.

HIV and AIDS also continue to take a devastating toll on women and children in developing countries, where more than 90 percent of all HIV/AIDS cases occur. In 2001, approximately 2.7 million children younger than age 15 were living with HIV/AIDS worldwide, and 580,000 children in this age group died from HIV-associated illnesses or AIDS, according to a UNAIDS report.(2) In addition to the suffering of children, 48 percent of adults living with HIV/AIDS in the world are women, many of whom are of childbearing age.(2) To this end, the PACTG will also directly support clinical research at four international sites, two in South Africa and two in Thailand.

"The Pediatric AIDS Clinical Trials Group has been instrumental in forging new prevention and treatment strategies for HIV-infected mothers and their children, and in working to extend and improve the quality of their lives," says Anthony S. Fauci, M.D., director of NIAID. "As the global scope of the epidemic evolves, the PACTG will continue to tackle the most critical needs in pediatric and adolescent HIV/AIDS research both in the United States and the developing world."

The new research agenda of the PACTG emphasizes five key areas:

• Perinatal Transmission: continue studying the safety of antiretroviral drugs in HIV-infected pregnant women; continue translational research for resource-poor international partners; and examine why current interventions are not fully successful.
• Pediatric Treatment: study the safety of new drugs, the best use of available drugs and treatment management; and evaluate the effect of interventions on the course of the disease.
• Adolescent Treatment: expand adolescent research to every PACTG site; study the effects of treatment on acute and early infection and on restoration of immune function; and promote collaborations to assist in prevention research, including behavioral research.
• Long-Term Evaluation of Antiretroviral Therapies: increase commitment to long-term pediatric studies; study drug safety in infants who escape infection and in children who become infected; and link durability of treatment responses to clinical outcomes.
• Domestic and International Collaborations: collaborate with other NIH-sponsored domestic and international HIV/AIDS therapeutic and prevention trials networks; encourage scientific exchange and resource-sharing with international partners; and conduct international studies of interventions that can be readily transferred to developing countries.

BACKGROUND

Before the PACTG was established, clinical studies of HIV-positive mothers, children and adolescents were carried out and funded through NIAID's AIDS Clinical Trials Group (ACTG). In 1995, an independent review panel recommended the PACTG become a separate entity from the ACTG. The PACTG was established as an independent network in 1997 and now comprises 18 Pediatric AIDS Clinical Trials Units funded by NIAID, and 35 domestic and international sites funded by the National Institute of Child Health and Human Development. To date, the PACTG has initiated 113 clinical trials and, as of December 2001, has enrolled approximately 27,432 women and children. Some noteworthy studies and findings include:

• The landmark study showing that AZT given to HIV-positive pregnant women and their newborns shortly after birth can greatly reduce the rate of HIV transmission (ACTG 076).
• Long-term follow-up studies of infected and uninfected but antiretroviral-exposed infants.
• Studies demonstrating that multi-agent combination treatment of HIV-infected pregnant women can lead to very low rates of HIV transmission to their infants.
• Numerous studies in HIV-infected women and children to determine appropriate doses of antiretrovirals and other drugs in these populations.
• Studies evaluating the use of highly active antiretroviral combinations in children, which contributed to establishing the standard of care for antiretroviral therapy in children.
• Research evaluating the restoration of immune responses after initiation of potent combination therapies.
• Studies elucidating the differences in the pathogenesis of acute HIV infection in infants compared with infection acquired by adolescents or adults.

For more information on pediatric or adult clinical trials, contact the AIDS Clinical Trials Information Service at 1-800-TRIALS-A (1-800-874-2572), 12 p.m. to 5 p.m. Eastern Time, Monday through Friday. Bilingual health specialists are available. You can also visit their Web site at http://www.actis.org.

Pediatric AIDS Clinical Trials Units and Principal Investigators

ALABAMA
University of Alabama at Birmingham
Robert Pass, M.D.

CALIFORNIA
University of California at Los Angeles
School of Medicine
Yvonne J. Bryson, M.D.

University of California at San Diego
Stephen A. Spector, M.D.

University of California at San Francisco
Moffit Hospital
Diane W. Wara, M.D.

FLORIDA
University of Miami School of Medicine
Gwendolyn B. Scott, M.D.

ILLINOIS
Children's Memorial Hospital/Chicago
Ram Yogev, M.D.

LOUISIANA
Tulane University Medical School/New Orleans
Russell Van Dyke, M.D.

MARYLAND
Johns Hopkins University School of
Public Health and Hygiene/Baltimore
Andrea Ruff, M.D.

MASSACHUSETTS
Children's Hospital/Boston
Kenneth McIntosh, M.D.

University of Massachusetts Medical School/Worchester
Katherine F. Luzuriaga, M.D.

NEW JERSEY
UMDNJ-New Jersey Medical School/Newark
Paul Palumbo, M.D.

NEW YORK
Bronx-Lebanon Hospital Center
Saroj Bakshi, M.D.

Columbia University College of
Physicians and Surgeons
Columbia Presbyterian Medical Center/New York City
Anne A. Gershon, M.D.

NORTH CAROLINA
Duke University Medical Center/Durham
Ross McKinney, Jr., M.D.

PENNSYLVANIA
Children's Hospital of Philadelphia
Stuart E. Starr, M.D.

PUERTO RICO
University of Puerto Rico
Pediatric Hospital/San Juan
Irma Febo, M.D.

TENNESSEE
St. Jude Children's Research Hospital/Memphis
Patricia Flynn, M.D.

TEXAS
Texas Children's Hospital/Houston
William T. Shearer, M.D., Ph.D.

STATISTICAL AND DATA MANAGEMENT CENTER
Harvard School of Public Health
Boston, MA
Michael D. Hughes, Ph.D.

COORDINATING AND RESEARCH OPERATIONS CENTER
Social & Scientific Systems, Inc.
Bethesda, MD
Steven A. Spector, M.D.

NIAID is a component of the National Institutes of Health (NIH). NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

________________________________
(1)Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report: Midyear Edition, 13(1), June 2001.
(2)UNAIDS. Report on the Global HIV/AIDS Epidemic: December 2001.