This proposal will continue an existing AIDS clinical trials unit at Washington University as part of the AIDS Clinical Trials Group, currently led by Dr. R. Schooley (U. of Colorado). The proposal projects that 100-120 new patients can be enrolled in clinical trials each year, as well as maintaining an existing population of 100-150 patients actively participating in ongoing studies. The ACTU plans to enroll patients in trials of primary HIV therapy (both antiviral and immunotherapy) as well as studies for opportunistic infections, cancers and neurological complications of HIV infection. Studies specifically designed for women will also be initiated at this site. This ACTU expects to enroll 30-40 patients with early HIV disease (CD4 counts 200-500) in antiretroviral studies, 40-50 patients with advanced HIV disease (CD4 counts <200) in out-patient studies of antiretroviral agents or of primary prophylaxis of opportunistic infection, 10-15 patients in studies of acute opportunistic infection, 10 patients in studies of HIV- associated malignancies or premalignant conditions, 5-10 patients in studies of the neurologic complications of HIV disease, and 5-10 patients in phase I or pharmacokinetic studies of antiretroviral agents (or of new agents for the treatment of opportunistic infections or malignancy). In all, approximately 50-40% of patients will be enrolled in studies primarily directed at treatment of HIV infection, and 40-50% of patients will be enrolled in studies of the complications of HIV infection. In addition, this ACTU will contribute to the ACTG's ambitious scientific agenda by actively participating in substudies, including virologic, immunologic and pharmacologic laboratory substudies, detailed neurologic evaluation of patients enrolled in primary infection trials, and epidemiologic and laboratory substudies for patients with opportunistic infection or malignancy. The ACTU will continue to have two clinics: the main unit at the university medical center, and the second at St. Louis Regional Medical Center. The latter, located at the only municipally- supported public hospital in St. Louis was specifically developed to increase access for minorities, drug-users, and other under-represented individuals. The ACTU will maintain its successful efforts to match enrollment in trials to the demography of the epidemic in St. Louis. We therefore anticipate that at least 35% of enrollment will be from the African-American community and at least 10% will be women. The ACTU will also direct a substantial effort communicating the goals and successes of clinical trials to the community, especially health care workers, and will continue to maintain an active Community Advisory Board. The project will maintain the existing immunology and virology core laboratories. Separate proposals for virology and immunology advanced technology laboratories will be forthcoming. ACTU investigators will provide scientific and administrative leadership to the group, especially in the areas of complications of HIV infection (where W. Powderly, site PI, heads the ACTG's Research Agenda Committee), and neurology (where D. Clifford leads the Neurology AIDS Research Consortium).
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