The Institute of Human Virology Clinical Trials Unit (IHV-CTU) integrates five clinical research sites (CRS) four in the US (a Baltimore-Washington consortium) and one in Nigeria, West Africa that focus on four major research objectives: Drug Research and Development;Optimization of Clinical Management for adult, adolescent and pediatric populations;HIV Prevention;and Vaccine Research and Development. The IHVCTU leadership, PI, William A. Blattner, MD, Co-Pi Robert R. Redfield MD and Co-Pi John F. Farley MD direct specific research areas and articulate complementary strengths in a collaborative process guided by the IHV-CTU communication plan to implement trials of highest GCP standard. The IHV-Treatment CRS, [Site Leader (SL) Charles Davis MD], with a 4000 person clinic base, targets Drug development and Optimization of Clinical Management. The Chase Brexton CRS (SL Patrick McLeroth, MD) employs a community clinical base to undertake Optimization of Clinical Management research trials, as does the Whitman Walker CRS, whose SL is Philippe Chiliade, MD. The Project BRAVE CRS, (SL William A. Blattner MD) with deep roots in the Baltimore community, targets HIV vaccine research and development. The IHV Nigeria CRS, SL John F. Farley MD, exploits a substantial 10,000 plus PEPFAR (President's Emergency Program for AIDS Relief) treatment cohort, to undertake HIV prevention trials among HIV discordant couples at risk for HIV CRF_02 AG infection. The IHV-CTU harmonizes research practice through organizational structures and a communication plan that employs uniform standard operating procedures (SOP) across all CRS, and clinical management working groups that optimize research practice. An Executive Committee comprised of the PI and Co-Pi allocate and reallocate resources to adapt to emerging clinical trial priorities guided by the Investigators Committee that advance the most promising interventions by re-allocating CTU resources. CRS community engagement through community-active advisory boards (CAB) are linked through the IHV-CTU CAB to effect community education and recruitment that effectively engages underserved African American populations in trials research. Results of this clinical research impact the public health by advancing HIV treatment standards, developing a vaccine, and learning more effective approaches to HIV prevention. 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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Special Emphasis Panel (ZAI1-SR-A (M2))
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Welsch, Sue A
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University of Maryland Baltimore
Internal Medicine/Medicine
Schools of Medicine
United States
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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
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
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
Verma, Shefali S; Frase, Alex T; Verma, Anurag et al. (2016) PHENOME-WIDE INTERACTION STUDY (PheWIS) IN AIDS CLINICAL TRIALS GROUP DATA (ACTG). Pac Symp Biocomput 21:57-68
Cillo, Anthony R; Hilldorfer, Benedict B; Lalama, Christina M et al. (2015) Virologic and immunologic effects of adding maraviroc to suppressive antiretroviral therapy in individuals with suboptimal CD4+ T-cell recovery. AIDS 29:2121-9
Tenorio, Allan R; Chan, Ellen S; Bosch, Ronald J et al. (2015) Rifaximin has a marginal impact on microbial translocation, T-cell activation and inflammation in HIV-positive immune non-responders to antiretroviral therapy - ACTG A5286. J Infect Dis 211:780-90
Moore, Carrie B; Verma, Anurag; Pendergrass, Sarah et al. (2015) Phenome-wide Association Study Relating Pretreatment Laboratory Parameters With Human Genetic Variants in AIDS Clinical Trials Group Protocols. Open Forum Infect Dis 2:ofu113
Lehmann, David S; Ribaudo, Heather J; Daar, Eric S et al. (2015) Genome-wide association study of virologic response with efavirenz-containing or abacavir-containing regimens in AIDS clinical trials group protocols. Pharmacogenet Genomics 25:51-9
Wanga, Valentine; Venuto, Charles; Morse, Gene D et al. (2015) Genomewide association study of tenofovir pharmacokinetics and creatinine clearance in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 25:450-61

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