This application proposes to establish the UNC-Chapel Hill Clinical Trials Unit (UNC-CH CTU) and its attendant clinical sites at UNC Chapel Hill, UNC Wake County Health and Human Services, Moses Cone Hospital, and Wake Forest University Health Sciences. This pluripotential unit and sites propose to efficiently recruit, enroll and retain subjects on protocols affiliated with three NIH-funded multi-center clinical research groups;Adult Aids Clinical Trials Group (ACTG), HIV Prevention Trials Network (HPTN), and HIV Vaccine Trials Network (HVTN) that will address four NIH/DAIDS clinical research priority areas: 1) Translational Research and Drug Development (ACTG), 2) Optimization of Clinical Management, including Co-morbidities (ACTG), 3) Prevention of HIV Infection (HPTN), and 4) HIV Vaccines (HVTN). The UNC-CH CTU and the four clinical research sites have extensive experience in HIV-related clinical trials including participation in the ACTS for 18 years as one of the premier units in that organization. The leadership of the Unit and Sites has the appropriate expertise to conduct these trials and to maximize the scientific opportunities by integrating this robust expertise in the 4 high priority research areas. The structure of the UNC-CH CTU and sites allows for flexible and responsive clinical research that will build and strengthen research capacity focusing on underserved populations in the Southeastern US, serving the population most affected by HIV in our country. Our Structure maximizes efficiency by sharing key resources amongst priority areas including investigators, sites and unit staff, training, protocol implementation, management, regulatory services, outreach, recruitment, and data management and data quality. The UNC CTU and its four Clinical Research Sites will improve the treatment of HIV and decrease HIV spread by contributing to HIV prevention strategies and HIV vaccine development. ADMINISTRATIVE COMPONENT:

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Study Section
Special Emphasis Panel (ZAI1-MH-A (M1))
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Pouliot, Eileen M
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University of North Carolina Chapel Hill
Internal Medicine/Medicine
Schools of Medicine
Chapel Hill
United States
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Flynn, Patricia M; Taha, Taha E; Cababasay, Mae et al. (2018) Prevention of HIV-1 Transmission Through Breastfeeding: Efficacy and Safety of Maternal Antiretroviral Therapy Versus Infant Nevirapine Prophylaxis for Duration of Breastfeeding in HIV-1-Infected Women With High CD4 Cell Count (IMPAACT PROMISE): A Randomi J Acquir Immune Defic Syndr 77:383-392
Robertson, Kevin R; Jiang, Hongyu; Kumwenda, Johnstone et al. (2018) HIV Associated Neurocognitive Impairment in Diverse Resource Limited Settings. Clin Infect Dis :
Chernoff, Miriam C; Laughton, Barbara; Ratswana, Mmule et al. (2018) Validity of Neuropsychological Testing in Young African Children Affected by HIV. J Pediatr Infect Dis 13:185-201
Boivin, Michael J; Barlow-Mosha, Linda; Chernoff, Miriam C et al. (2018) Neuropsychological performance in African children with HIV enrolled in a multisite antiretroviral clinical trial. AIDS 32:189-204
Kalayjian, Robert C; Albert, Jeffrey M; Cremers, Serge et al. (2018) Women have enhanced bone loss associated with phosphaturia and CD4+ cell restoration during initial antiretroviral therapy. AIDS 32:2517-2524
Palumbo, Philip J; Fogel, Jessica M; Hudelson, Sarah E et al. (2018) HIV Drug Resistance in Adults Receiving Early vs. Delayed Antiretroviral Therapy: HPTN 052. J Acquir Immune Defic Syndr 77:484-491
Rhodes, Scott D; Tanner, Amanda E; Mann-Jackson, Lilli et al. (2018) Community-Engaged Research as an Approach to Expedite Advances in HIV Prevention, Care, and Treatment: A Call to Action. AIDS Educ Prev 30:243-253
Martin, Maureen P; Naranbhai, Vivek; Shea, Patrick R et al. (2018) Killer cell immunoglobulin-like receptor 3DL1 variation modifies HLA-B*57 protection against HIV-1. J Clin Invest 128:1903-1912
Hosseinipour, Mina C; Kang, Minhee; Krown, Susan E et al. (2018) As-Needed Vs Immediate Etoposide Chemotherapy in Combination With Antiretroviral Therapy for Mild-to-Moderate AIDS-Associated Kaposi Sarcoma in Resource-Limited Settings: A5264/AMC-067 Randomized Clinical Trial. Clin Infect Dis 67:251-260
Haas, David W; Bradford, Yuki; Verma, Anurag et al. (2018) Brain neurotransmitter transporter/receptor genomics and efavirenz central nervous system adverse events. Pharmacogenet Genomics 28:179-187

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