The National Institute of Allergy and Infectious Diseases (NIAID) has awarded 23 four-year grants to continue the work of the Pediatric AIDS Clinical Trials Group (ACTG). A nationwide clinical trials network, the group evaluates improved strategies to prevent infants of infected mothers from acquiring HIV in utero or during birth, and for treating children and adolescents already infected with the virus. First-year funding for the new awards totals $32 million.
The money will support 21 AIDS Clinical Trials Units (ACTUs, listed below), a Statistical and Data Management Center, and a new Pediatric ACTG Coordinating and Operations Center. The latter will provide scientific and managerial leadership and perform centralized, advanced laboratory studies.
Through June 1996, 9,870 cases of AIDS in children and adolescents as old as 19 years had been reported to the U.S. Centers for Disease Control and Prevention (CDC). Of the 7,296 cases in children under age 13, nine out of 10 patients acquired HIV perinatally from their infected mothers. These data reinforce the need to develop better strategies to prevent and treat mother-to-infant HIV transmission.
The Pediatric ACTG brings together a superbly qualified group of investigators focused on the special problems of preventing and treating AIDS and associated opportunistic infections in infants, children and adolescents," comments NIAID Director Anthony S. Fauci, M.D. "We are confident that the Pediatric ACTG will continue to make significant contributions to improving the lives of all young people infected with HIV."
Stephen A. Spector, M.D., principal investigator of the University of California at San Diego ACTU, will be Group Leader of the Pediatric ACTG. As such, he will direct its Coordinating and Operations Center, which will be managed by Social and Scientific Systems in Bethesda, Md.
The restructured Pediatric ACTG will greatly enhance our ability to conduct trials that address questions of high public health and scientific priority," says Dr. Spector. One group priority is to incorporate pathogenesis-based research into clinical trials. These studies will enable the ACTU investigators to better define the course of disease in children and to analyze how HIV infection and its treatments affect the developing immune system. The Pediatric ACTG is uniquely suited to carry out such studies because they require integrating clinical and laboratory research. The Statistical and Data Management Center will be headed by Richard Gelber, Ph.D., of the Harvard School of Public Health.
The 21 clinical trials sites include 20 of the 22 current NIAID-sponsored Pediatric ACTUs and one new site in Alabama. The funding level for the Pediatric ACTG is consistent with the recommendations of the Report of the NIH AIDS Research Program Evaluation Working Group, chaired by Princeton virologist Arnold Levine, Ph.D. This report -- an external review of the NIH AIDS program issued by the NIH Office of AIDS Research in 1996 -- recommended a decreased level of funding for the Pediatric ACTG given the changing epidemiology of HIV infection in children in the United States.
In addition to the NIAID-sponsored components of the Pediatric ACTG, the National Institute of Child Health and Human Development (NICHD) currently funds 33 smaller clinical trials sites. The NICHD investigators participate in group committees and protocol development teams, enroll patients and share the same scientific group leadership as NIAID. Together, these 54 clinical sites provide the structure and resources for addressing the Pediatric ACTG's goals.
Moreover, through the Ryan White Service Program, the U.S. Public Health Service enhances pediatric AIDS clinical research by providing resources such as day care and travel money to facilitate the participation of HIV-infected women and children in NIH-sponsored clinical research. Health care providers receiving funds from this program are located near 20 of the 21 NIAID clinical sites and can easily make patient referrals to the group's trials.
As of February 1997, the Pediatric ACTG had initiated 60 trials, and 27 studies are now recruiting patients. Cumulative enrollment since 1987 totals 10,867 children, adolescents and pregnant women. Among its most significant contributions, the group has: 1) demonstrated that antiretroviral therapy given to HIV-infected pregnant women and their newborns can reduce the risk of perinatal transmission by two thirds; 2) showed that IVIG can effectively prevent serious bacterial infections in children with HIV; 3) demonstrated that ddI or ddI plus AZT are superior to AZT monotherapy for children with symptomatic HIV infection or AIDS; and 4) developed guidelines for preventing Pneumocystis carinii pneumonia in HIV-infected children.
The original NIAID ACTG established in 1987 included two sites that enrolled children with AIDS. Additional pediatric sites were added in 1988 and 1989, and again in 1992. Following recommendations of an independent advisory panel, the Adult and Pediatric ACTGs will now operate separately. Currently there are 30 adult clinical sites.
For information on Pediatric ACTG trials currently open to enrollment, call the AIDS Clinical Trials Information Service at 1-800-TRIALS-A (1-800-874-2572), Monday through Friday, 9:00 a.m. to 7:00 p.m. Eastern time. Bilingual health specialists are available to talk to Spanish-speaking callers.
NIAID and NICHD are components of the National Institutes of Health (NIH). NIAID conducts and supports research aimed at preventing, diagnosing and treating illnesses such as AIDS and other sexually transmitted diseases, tuberculosis, asthma and allergies. NIH is an agency of the U.S. Department of Health and Human Services.
NIAID Pediatric AIDS Clinical Trials Units and Principal InvestigatorsALABAMA: