ADULT AIDS CLINICAL TRIALS UNIT

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The Mount Sinai/Beth Israel Adult AIDS Clinical Trials Unit (ACTU) is applying for competitive renewal of its multi-hospital consortium, a member of the AIDS Clinical Trials Group (ACTG) program since 1987. Our unit has demonstrated leadership in its ability to generate protocols and contribute to a multidisciplinary scientific agenda, to recruit a diverse patient population with HIV infection, coordinate data and specimen collection, perform virologic and immunologic evaluations as well as pharmacokinetic studies, collect and report high quality clinical and laboratory data, and collaborate with NIAID and other institutions involved in adult and pediatric trials. This unit has enrolled more than 1,000 patients on over 60 different protocols, and has consistently been among the leaders in enrollment of women, minorities, and intravenous drug users. Based on data in the ACTG nationwide database as of 12/16/94, our unit was first in enrollment of patients with a history of IV drug use, second in the number of Hispanics, third in total number of women enrolled, and fourth in the number of Blacks enrolled of all ACTUs across the country. We were first in each of these categories in New York State, except women. By integrating and coordinating access to clinical trials with access to clinical care, despite a decrease in our total budget request, we propose: (1) to accrue and retain a minimum of 75 new patients per year in diverse multicenter trials of new treatments for human immunodeficiency virus type 1 (HIV-1) infection and the associated opportunistic infections and malignancies. The studies will be conducted at hospitals which serve some of the highest AIDS prevalence areas in the country and can offer access to trials to large numbers of HIV-infected persons from groups which have been traditionally underrepresented in AIDS trials. By capitalizing on the investigative strengths of our multidisciplinary research team, recruited from within and outside our institutions, we also propose: (2) to contribute to the design and conduct of trials that will explore the pathogenesis of HIV-1 infection and further the research agendas of the ACTG Scientific Committees.