This application will continue an existing AIDS clinical trials unit at Washington University as part of the Adult AIDS Clinical Trials Group, currently led by Dr. R. Schooley at the University of Colorado. The application projects the enrollment of 100 to 120 new patients in clinical trials each year, and the maintenance of an existing population of 100 to 150 patients in ongoing studies. The applicants plan to enroll patients in trials of primary HIV therapy including antiviral and immunotherapy and in studies on opportunistic infections, metabolic and neurological complications of HIV infection. Studies specifically designed for women also will be initiated. Approximately 70 to 80 percent of patients will be enrolled in studies primarily directed at the treatment of HIV infection, and 20 to 30 percent of patients will be enrolled in studies of the complications of HIV infection. In addition, this ACTU will contribute to the AACTG's ambitious scientific agenda by actively participating in substudies involving virologic, immunologic and pharmacologic laboratory substudies, detailed neurologic evaluation of patients enrolled in primary infection trials, and epidemiological and laboratory substudies for patients with opportunistic infection or metabolic problems. Scientifically, the ACTU investigators will focus on providing leadership in antiretroviral trials, specifically studies of salvage therapy for failing antiretroviral treatment or intensification of early failures. The applicants also will focus on complications of HIV infection, notably prophylaxis of opportunistic infection, and studies of the neurologic and metabolic complications of the disease and/or its treatment. The ACTU will continue to have two clinics with the main unit at the University medical center, and the second at St. Louis Connectcare. The latter, located at the only municipally supported health care facility in St. Louis, was specifically developed to increase access for minorities, drug-users, and other underrepresented individuals. The ACTU will maintain its successful efforts to match enrollment in trials to the demography of the epidemic in St. Louis. It is anticipated that at least 35 percent of enrollment will be from the African-American community and at least 10 percent will be women. The ACTU also will direct a substantial effort to communicating the goals and successes of clinical trials to the community, especially health care workers, and the Unit will continue to maintain an active Community Advisory Board.
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