1. What is the mission of the Pediatric AIDS Clinical Trials Group (PACTG)?
The Pediatric AIDS Clinical Trials Group (ACTG) evaluates innovative interventions to prevent HIV infection of infants, and to improve the quality and duration of life of HIV-infected infants, children and adolescents. Specifically, the goals of the Pediatric ACTG are:
* to evaluate therapeutic approaches for the prevention of pediatric HIV infection resulting from mother-infant transmission during pregnancy or delivery;
* to evaluate innovative strategies and interventions to control HIV infection and its complications in infants, children and adolescents; and
* to provide a flexible resource for state-of-the-art, multidisciplinary, multicenter clinical trials that address the goals and objectives of NIAID's therapeutics research agenda on pediatric HIV disease, including small pathogenesis-based studies.
2. What is the history and current structure of the PACTG?
The ACTG was established in 1987, building on NIAID's first major program for the evaluation of potential treatments for AIDS, which began in the summer of 1986. The original 36 AIDS Clinical Trials Units (ACTUs) included two sites that enrolled children with AIDS. Additional pediatric sites were added between 1988 and 1989, and again in 1992.
Following recommendations of an independent advisory panel, the adult and pediatric components of the ACTG now operate separately. The Adult ACTG includes 30 ACTUs, a Statistical and Data Management Center, and a Coordinating and Operations Center that manages the Adult ACTG, provides scientific direction and performs advanced laboratory studies. The new Pediatric ACTG will include 21 ACTUs, a Statistical and Data Management Center, and a Coordinating and Operations Center that will coordinate the pediatric effort through a similar structure.
In addition, the National Institute of Child Health and Human Development (NICHD) funds 33 pediatric ACTUs.
3. What is the chronology of the recent peer review of the Pediatric ACTG?
NIAID published a Request for Applications (RFA) for the competitive renewal of the Pediatric ACTG in February 1996. Twenty-five applications were received and peer reviewed. One incumbent (University of Colorado at Denver) did not reapply. Based on this review and the funds available, 21 site awards are being made to 20 incumbent sites and one new site at the University of Alabama.
4. How were applications in response to the Pediatric ACTG RFA reviewed?
Two peer review committees evaluated and scored the applications; one committee evaluated and scored the applications for the Statistical and Data Management Center application (September 1996); and one reviewed and scored applications for both the Coordinating and Operations Center and the Pediatric ACTUs (October 1996). To encourage coordination and consistency between the committees, selected reviewers participated in the review of applications for the Operations Center, Statistical Center and the ACTUs. To avoid any conflict of interest, the committee members did not review applications with which they were associated.
The applications approved for further consideration, together with a summary statement, which contained a synopsis of the peer review evaluation and the priority score for each application, were then reviewed by the National Advisory Allergy and Infectious Diseases Council (January 1997) for a second level of peer review.
5. Who was on the peer review committees?
The peer review committees were composed primarily of non-Federal experts who assessed the qualifications of each application based on the review criteria included in the RFA. Members included clinical and laboratory investigators, biostatisticians, primary care providers, clinical research staff, community representatives and individuals with experience in working with racial and ethnic minorities.
6. What role did geography and demographics play in site selection?
Each application had to demonstrate that the site's patient population was representative of the HIV/AIDS population in its catchment area. Applicants were also instructed to describe their plans for the inclusion of women and underrepresented minority populations in clinical trials. Reviewers evaluated the applications based on these criteria but did not specifically take geographic location into consideration. The predominant criteria for funding priorities were scientific and technical merit of the application in response to the RFA.
7. What is the total amount of the Pediatric ACTG awards?
The NIAID plans to fund one Coordinating and Operations Center, one Statistical and Data Management Center and 21 Pediatric ACTUs. A total of $32,000,000 is available for the first year of support. This level of support is consistent with the Report of the NIH AIDS Research Program Evaluation Working Group (Levine Report), which recommended significant reductions in allocations to the PACTG.
8. Will the number of clinical sites affect the ability of the Pediatric ACTG to accomplish its goals?
No. Under this RFA, 21 pediatric ACTUs are being funded. NIAID currently supports 22 pediatric ACTUs. The NICHD funds an additional 33 sites. Together, these 55 clinical sites provide the structure and resources for addressing the PACTG's scientific priorities.
9. What other Federal programs are specifically directed toward clinical therapeutics research in HIV-infected children and pregnant women?
The National Institute of Child Health and Human Development funds 33 clinical trials sites that participate in the PACTG research studies. The Health Resources and Services Administration's Ryan White Title IV program provides resources to facilitate the participation of HIV infected women and children in NIH sponsored clinical research. HRSA Ryan White Title IV investigators are located near 20 of the 21 NIAID sites.
10. What will the "phase-out" of the unsuccessful incumbent(s) involve?
Phase-out funding will be provided to the unsuccessful incumbent(s) for up to 12 months beginning March 1997.
Office of Communications National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda, MD 20892
U.S. Department of Health and Human Services