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 #
3U01AI069423-03S1
Application #
7900104
Study Section
Special Emphasis Panel (ZAI1-MH-A (M1))
Program Officer
Pouliot, Eileen M
Project Start
2009-08-13
Project End
2011-11-30
Budget Start
2009-08-13
Budget End
2011-11-30
Support Year
3
Fiscal Year
2009
Total Cost
$3,036,786
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
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
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
Venuto, Charles S; Lim, Jihoon; Messing, Susan et al. (2018) Inflammation investigated as a source of pharmacokinetic variability of atazanavir in AIDS Clinical Trials Group protocol A5224s. Antivir Ther 23:345-351
Li, Binglan; Verma, Shefali S; Veturi, Yogasudha C et al. (2018) Evaluation of PrediXcan for prioritizing GWAS associations and predicting gene expression. Pac Symp Biocomput 23:448-459
Wood, Daniel; Lancaster, Kathryn E; Boily, Marie-Claude et al. (2018) Recruitment of Female Sex Workers in HIV Prevention Trials: Can Efficacy Endpoints Be Reached More Efficiently? J Acquir Immune Defic Syndr 77:350-357
Gupta, Samir K; Yeh, Eunice; Kitch, Douglas W et al. (2017) Bone mineral density reductions after tenofovir disoproxil fumarate initiation and changes in phosphaturia: a secondary analysis of ACTG A5224s. J Antimicrob Chemother 72:2042-2048
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
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
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
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

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