The Vanderbilt HIV Clinical Trials Unit (CTU) will consist of an Administrative Component (AC), supporting the HIV Vaccine Clinical Research Site (Vaccine CRS) and the HIV Therapeutics Clinical Research Site (Therapeutics CRS). The long term objectives are to develop an effective: vaccine to prevent HIV infection and to provide HIV-infected patients with new and better therapies to control HIV and it's coinfections as well as to optimize clinical management by minimizing toxicities and complications. The AC will serve several functions: management/overall coordination of the CTU and Leadership Network relationships as well as financial management;scientific coordination and strategic planning;provision of functions and resources shared between the CRSs;leading and supporting community relationships. The location in the epicenter of the epidemic in the Southeast, as well as the proven track records of the proposed investigators and already established research sites provide a strong rationale for this application. """"""""The Vaccine CRS w II continue the outstanding performance of the current Vanderbilt HIV Vaccine Trials Unit. Vanderbilt was included as a preferred site by the HIV Vaccine Trials Network Leadership in their May 2005 submission of a Leadership Network application. The Vaccine CRS will make important contributions to each of the specific aims in the clinical research plan of the proposed vaccine network by enrollment of uninfected volunteers from all risk groups into vaccine trials, expanded recruitment of minority populations, and provision of highly experienced personnel for trials performance and scientific leadership / protocol development for the Network. The Therapeutics CRS will continue the exemplary performance of the current Vanderbilt Adult AIDS Clinical Trials Unit. Vanderbilt was included as a preferred site by the AIDS Clinical Trials. Group Leadership in their May 2005 submission of a Leadership Network application. This CRS will make important contributions to most specific aims of the clinical research plan of the proposed treatment research network. The focus will be on translational research and drug development, as well as optimization of clinical management. This will be facilitated by the Therapeutics CRS's proven ability to enroll H V-infected subjects, a strong plan to further increase enrollment of underserved populations including minoriti3s and subjects from rural areas, established high-quality trials performance, and a record of scientific leadership and accomplishment. Public health will benefit from prevention and better long-term medical treatment of HIV infection. ADMINISTRATIVE COMPONENT:

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-KS-A (M3))
Program Officer
Castillo, Blanca E
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Vanderbilt University Medical Center
Internal Medicine/Medicine
Schools of Medicine
United States
Zip Code
Landovitz, Raphael J; Tran, Thuy Tien T; Cohn, Susan E et al. (2016) HIV Transmission Risk Behavior in a Cohort of HIV-Infected Treatment-Naïve Men and Women in the United States. AIDS Behav 20:2983-2995
Jacobson, Jeffrey M; Zheng, Lu; Wilson, Cara C et al. (2016) The Safety and Immunogenicity of an Interleukin-12-Enhanced Multiantigen DNA Vaccine Delivered by Electroporation for the Treatment of HIV-1 Infection. J Acquir Immune Defic Syndr 71:163-71
Chan, Ellen S; Landay, Alan L; Brown, Todd T et al. (2016) Differential CD4+ cell count increase and CD4+ :  CD8+ ratio normalization with maraviroc compared with tenofovir. AIDS 30:2091-7
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
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
Schackman, Bruce R; Haas, David W; Park, Sanghee S et al. (2015) Cost-effectiveness of CYP2B6 genotyping to optimize efavirenz dosing in HIV clinical practice. Pharmacogenomics 16:2007-18
Luetkemeyer, Anne F; Rosenkranz, Susan L; Lu, Darlene et al. (2015) Combined effect of CYP2B6 and NAT2 genotype on plasma efavirenz exposure during rifampin-based antituberculosis therapy in the STRIDE study. Clin Infect Dis 60:1860-3
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
Taiwo, Babafemi O; Chan, Ellen S; Fichtenbaum, Carl J et al. (2015) Less Bone Loss With Maraviroc- Versus Tenofovir-Containing Antiretroviral Therapy in the AIDS Clinical Trials Group A5303 Study. Clin Infect Dis 61:1179-88
Brown, Todd T; Moser, Carlee; Currier, Judith S et al. (2015) Changes in Bone Mineral Density After Initiation of Antiretroviral Treatment With Tenofovir Disoproxil Fumarate/Emtricitabine Plus Atazanavir/Ritonavir, Darunavir/Ritonavir, or Raltegravir. J Infect Dis 212:1241-9

Showing the most recent 10 out of 88 publications