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:

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI069423-05
Application #
7990424
Study Section
Special Emphasis Panel (ZAI1-MH-A (M1))
Program Officer
Pouliot, Eileen M
Project Start
2007-02-01
Project End
2013-11-30
Budget Start
2010-12-01
Budget End
2011-11-30
Support Year
5
Fiscal Year
2011
Total Cost
$4,779,318
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Gulick, Roy M; Wilkin, Timothy J; Chen, Ying Q et al. (2017) Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Trial. Ann Intern Med 167:384-393
Bednasz, Cindy J; Venuto, Charles S; Ma, Qing et al. (2017) Efavirenz Therapeutic Range in HIV-1 Treatment-Naive Participants. Ther Drug Monit 39:596-603
Verma, Anurag; Bradford, Yuki; Verma, Shefali S et al. (2017) Multiphenotype association study of patients randomized to initiate antiretroviral regimens in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 27:101-111
Tassiopoulos, Katherine; Abdo, Mona; Wu, Kunling et al. (2017) Frailty is strongly associated with increased risk of recurrent falls among older HIV-infected adults. AIDS 31:2287-2294
Riddler, Sharon A; Aga, Evgenia; Bosch, Ronald J et al. (2016) Continued Slow Decay of the Residual Plasma Viremia Level in HIV-1-Infected Adults Receiving Long-term Antiretroviral Therapy. J Infect Dis 213:556-60
Ritchwood, Tiarney D; Hughes, James P; Jennings, Larissa et al. (2016) Characteristics of Age-Discordant Partnerships Associated With HIV Risk Among Young South African Women (HPTN 068). J Acquir Immune Defic Syndr 72:423-9
Weinberg, Adriana; Park, Jeong-Gun; Bosch, Ronald et al. (2016) Effect of Depot Medoxyprogesterone Acetate on Immune Functions and Inflammatory Markers of HIV-Infected Women. J Acquir Immune Defic Syndr 71:137-45
Roman Isler, M; Golin, C; Wang, J et al. (2016) Venues for Meeting Sex Partners and Partner HIV Risk Characteristics: HIV Prevention Trials Network (HPTN064) Women's HIV Seroincidence Study (ISIS). AIDS Behav 20:1208-18
La Rosa, Alberto M; Harrison, Linda J; Taiwo, Babafemi et al. (2016) Raltegravir in second-line antiretroviral therapy in resource-limited settings (SELECT): a randomised, phase 3, non-inferiority study. Lancet HIV 3:e247-58
Frew, Paula M; Parker, Kimberly; Vo, Linda et al. (2016) Socioecological factors influencing women's HIV risk in the United States: qualitative findings from the women's HIV SeroIncidence study (HPTN 064). BMC Public Health 16:803

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