Mount Sinai's Adult AIDS Clinical Trials Unit (ACTU) is applying for competitive renewal of its multi-hospital consortium to conduct clinical trials of new treatments for HIV infection and the associated opportunistic infections and malignancies. Our unit has been a member of the ACTG program since 1987 and has developed the capability to develop protocols, to recruit patients with HIV infection, coordinate data and specimen collection, perform virologic and immunologic evaluations, as well as pharmacokinetic studies, maintain quality control of laboratory results and data entry, develop protocols, and collaborate with NIAID and the other institutions involved in adult and pediatric trials. This unit has enrolled over 500 patients on 34 different protocols, and has consistently been among the leaders in enrollment of women, minorities, and intravenous drug users. The studies will be conducted at four hospitals (Mount Sinai Hospital, Beth Israel Medical Center, The Bronx VA Medical Center and The City Hospital Center at Elmhurst) which serve some of the highest AIDS incidence areas in the country and can offer access to trials to large numbers of HIV infected patients from groups which have been underrepresented in AIDS trials. To further enhance minority enrollment, we will establish a new satellite unit at North General Hospital, the only remaining voluntary hospital in Harlem. The unit also provides organizational and laboratory support to Mount Sinai's Pediatric ACTU. By integrating and coordinating access to clinical trials with access to clinical care, and by expanding our ACTU staff, we propose to accrue and retain 150 new patients per year.
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