This renewal application for the Pediatric AIDS Clinical Trials Unit at the University of Miami School of Medicine proposes the conduct of clinical trials in pregnant women, children and adolescents with HIV infection. We propose to enroll 100 patients into various protocols placing special emphasis on the areas of perinatal transmission of HIV infection, antiretroviral therapy in pediatric populations, and the prophylaxis and treatment of opportunistic infection in children. This program, consisting of a pediatric unit, an obstetrical unit and a virology core laboratory has a distinguished record over the past five years. The program faculty have provided scientific input into the conduct of clinical trials both nationally and locally and have pioneered the treatment of children and pregnant women with HIV infection through both Phase I and Phase II/III trials. Over 90% of the women and children recruited into treatment protocols have been members of minority groups. The extensive infrastructure of social and medical services available at the medical center has facilitated the conduct of trials. In this proposal,the addition of a new subunit at the Children's Diagnostic Center in Fort Lauderdale is proposed. This subunit is located 25 miles to the north of Miami and would allow access to clinical trials for a large number of infected children. The virology laboratory component has participated in research protocols in pediatric patients since 1983 and is fully certified by the ACTG. In addition, there is an ACTG certified immunology laboratory on campus which is proposed as an immunology core. Three developmental grants in each of the stipulated areas and applications for core virology and immunology laboratories accompany the core application. Long term goals of this project include the interruption of perinatal transmission of HIV, the preservation of the immune system, delayed progression of disease and prolonged survival. The strengths of this program lie in its already existing collaborations among the program faculty, their scientific expertise, research experience and publication record, the prior experience in clinical trials, the extensive supportive infrastructure for patient care, the extensive experience in caring for women and children with HIV infection, the integration with existing community programs, and the large number of patients available for recruitment into trials.
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