ADULT AIDS CLINICAL TRIALS UNIT

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DESCRIPTION (adapted from the application's abstract): The Ohio State University AIDS Clinical Trials Unit (ACTU) proposes to collaborate with the Adult ACTG Coordinating and Research Operations Center (CORC) that has identified Robert T. Schooley, M.D., from the University of Colorado as Group Leader. The Ohio State University ACTU proposes to participate in the discovery and development of therapies to improve the quality and duration of life of Human Immunodeficiency Virus (HIV)-infected individuals. The proposed cadre of investigators are from multiple disciplines including infections diseases, virology, immunology, nursing, oncology, neurology, gynecology and clinical pharmacology. They have conducted single- and multi-center HIV/AIDS clinical trials and have established multi-disciplinary collaborations to participate in the AACTG scientific agenda. There are nursing, pharmacy, social work, data management and outreach personnel proposed to: recruit and screen potential patients including women and minorities; implement clinical research protocols; perform protocol required assessments; dispense investigational agents and appropriately document clinical events; and meet all data reporting requirements. There are certified laboratory facilities proposed to conduct or obtain virologic, immunologic and pharmacologic assays in support of AACTG clinical trials with appropriate internal quality controls. There are clinical facilities proposed, including a dedicated Infectious Diseases inpatient service, a full-time outpatient clinic with an ACTU pharmacy and a General Clinical Research Center to execute protocols and provide clinical care in an integrated fashion.