BALTIMORE PEDIATRIC AIDS CLINICAL TRIALS GROUP

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The Baltimore Pediatric ACTG, a collaborative effort between Johns Hopkins and the University of Maryland, was funded in 1988 with the intent of providing access to clinical trials for HIV-infected children throughout the city of Baltimore and the state of Maryland. Since its inception, the PBACTG has enrolled 244 children in 25 protocols with minimal loss to follow-up and has contributed substantially to the ACTG agenda, providing the chairs for major scientific committees, protocol chairs, and protocol team members. Both institutions remain highly committed to continuing and expanding these collaborative efforts. We propose to continue these activities with an emphasis on each of the four scientific areas prioritized by the PACTG CORC: perinatal transmission, primary therapy, opportunistic infections and immunology, Thus, the BPACTG will continue to participate in perinatal trials, phase I, II and III trials, and in trials evaluating immune-based therapy. Given our institutional resources, we believe these areas represent strengths within the BPACTG and are areas in which we will contribute substantially to the ACTG scientific leadership. Recent problems with enrollment and data management have been identified and are being addressed by the BPACTG leadership. We therefore anticipate enrolling well over the minimum number of protocol naive HIV-infected children and HIV-infected pregnant women required by the RFA. We expect to continue our high enrollment ang retention of minority groups, reflecting the demographics of HIV infection in the region, and through increased outreach efforts and collaboration with the JHU and UMAB Adolescent Clinics we expect to increase our enrollment of HIV-infected adolescents. During the past 8 years we have established an effective network of researchers and providers in the BPACTG who serve the HIV-infected youth and expectant women of the region. The addition of new investigators to the BPACTG has further strengthened each or our individual units and through our collaborative efforts we currently have the capability, organization, and linkages with the community to successfully provide HIV-infected infants, children, adolescents and pregnant women of the region with access to ACTG clinical trials.