A center for therapeutic studies of pediatric HIV infection in LA County is proposed, located at UCLA and Children's Hospital of Los Angeles (CHLA). It will nave a close interaction with the existing AIDS Treatment Evaluation Unit at UCLA, particularly for immunologic studies, virologic studies, data management and statistical support. At CHLA a large group of HIV infected children are followed, and their pharmacology division will perform Phase I studies on antiviral agents, using the facilities of the UCLA Clinical Research Center. To enroll high risk women with an increased rate of HIV seropositivity, 7 other centers in LA County, including Cedars-Sinai Hospital, Olive View Medical Center, LAC/USC Medical Center, Martin Luther King Medical Center, UCLA/Harbor General Hospital, Long Beach Memorial Hospital, and the network of Kaiser Hospitals will join the center. Coordinators are identified at these centers. The LA County Department of Health will begin testing all high risk mothers for HIV positivity and their children will be enrolled at these centers. We have 118 patients (62 asymptomatic, 41 ARC, and 15 AIDS) for study and another 100 untested hemophiliacs. Our network with its 70,000 annual deliveries, should identify 50 older children and 100 newborns with HIV infection per year, and increasing numbers in subsequent years. The proposal includes a description of the network, personnel, facilities and organization, detailed sample protocols for Phase I and II antiviral studies, priorities for HIV therapy in children, and a 5 year plan. Exceptional strengths in clinical trial design, immunology, clinical pharmacology, and virology, data management and statistical analysis are documented. Close interaction with outstanding clinical investigators and laboratory scientists will shorten the time between basic science advances and clinical applicability.
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