The Ohio State University AIDS Clinical Trials Unit (ACTU) proposes to collaborate with the Adult ACTG Central Group that has identified Robert T. Schooley, M.D. from the University of Colorado as Group Leader. We wish to participate in the discovery and development of therapies that will improve the quality and duration of life of Human Immunodeficiency Virus (HIV)-infected individuals. We have a cadre of experienced investigators from multiple disciplines including infectious diseases, virology, immunology, gene therapy, oncology, neurology, gynecology, and clinical pharmacology who have demonstrated expertise conducting single- and multi-center HIV/AIDS clinical trials and in establishing multi- disciplinary collaborations to participate in the NIAID/ACTG scientific agenda. We have the nursing, pharmacy, social work, data management and outreach personnel 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, meeting all data reporting requirements. We have the certified laboratory facilities to conduct or obtain virologic, immunologic and pharmacologic assays in support of ACTG clinical trials with adequate internal quality control. We have the clinical facilities 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.
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