University of North Carolina Global HIV Prevention and Treatment Clinical Trials

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DESCRIPTION (provided by applicant): The University of North Carolina (UNC) Global HIV Clinical Trials Unit (CTU) has a well established track record of high-quality, innovative clinical research, strong scientific leadership (both in and outside the NIH HIV/AIDS Networks), and access to critically important infected and at-risk populations in the Southeastern US and in Southern Africa. Drawn from a diverse team of clinical innvestigators spanning two continents, our CTU will be led by three experienced principal investigators (Joseph Eron MD, Jeffrey Stringer MD and Mina Hosseinipour MD) and will support all 5 NIH HIV Clinical Trials Networks: Adult Therapeutic Strategies, Strategies to Address HIV and HIV-associated Infections in Pediatric and Maternal Populations, Integrated HIV Prevention Strategies, Microbicide Strategies, and Vaccine Strategies to Prevent HIV Infection. The 5 Clinical Research Sites (CRS) will include Chapel Hill CRS led by David Wohl MD (Adult Therapeutic Strategies, Integrated Prevention, Microbicide and Vaccine), Raleigh CRS led by Kristine Patterson MD (Adult Therapeutic Strategies, Integrated Prevention, Vaccine), Greensboro CRS led by Cornelius Van Dam MD PhD (Adult Therapeutic Strategy and Integrated Prevention), Malawi CRS led by Francis Martinson MD PhD (all 5 Networks) and Zambia CRS led by Benjamin Chi MD (all 5 Networks). Supporting this leadership will be Network Science Teams, comprising global experts and site collaborators who will work to execute the network scientific agendas. The CTU has also assembled a diverse group of senior scientists and public health officials to serve on our Scientific and Strategic Advisory Group. The CTU administration incorporates a highly organized structure that will be responsive to our experienced research teams across the 5 sites and will provide ongoing evaluation to ensure optimal performance and efficiency. The CTU will be supported by state-of-the-art communications and has assembled outstanding laboratory, pharmacy, quality assurance, data management and regulatory support. With its robust administrative framework, the UNC Global HIV CTU will be uniquely positioned to provide scientific leadership and clinical trials infrastructure to advance the field of agenda of he NlAID networks.