The HIV pandemic is one of the greatest ongoing threats to health and development, over 30 years past its recognition. The NIAID-funded Clinical Trials Networks have played critical roles in the coordinated response to key research questions in the HIV/AIDS field. The proposed Vanderbilt Clinical Trials Unit (CTU) is a partnership between Vanderbilt University and Washington University, comprising three top-performing incumbent Clinical Research Sites (CRSs) that span the therapeutics mission of the AIDS Clinical Trials Group (ACTG) and the vaccine mission of the HIV Vaccine Trials Network (HVTN). This builds upon the already established partnership between the Vanderbilt Therapeutics CRS and the Vanderbilt Vaccine CRS, and adds a new partnership with the Washington University Therapeutics CRS. The latter two sites have been members of the HVTN and ACTG since the inception of these Networks in 1987-1988. The leaders of this CTU have made high-impact, unique scientific and programmatic contributions to the Networks in areas that include human genomics and neurological aspects of HIV disease. Moving forward this CTU will continue its track record of programmatic impact by leveraging Vanderbilt's institutional strength in biomedical informatics to implement flexible, real-time, shareable informatics tools to optimize CTU performance. This CTU also benefits from close ties to other major NIH programs including Vanderbilt's roles as Coordinating Center for the nationwide network of approximately 60 Clinical and Translational Science Awards (CTSA), for the seven worldwide regions of the NIAID-sponsored International Epidemiologic Databases to Evaluate AIDS (leDEA), and for the seven countries of leDEA's Latin American region. During the proposed finding period the Vanderbilt CTU will make substantial contributions to the ACTG's scientific priorities focused on HIV/AIDS, tuberculosis, and viral hepatitis, and will make substantial contributions to the HVTN's major scientific priority of developing and testing a safe and effective vaccine for HIV.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-RCU-A (S5))
Program Officer
Welsch, Sue A
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
Li, Shuying S; Kochar, Nidhi K; Elizaga, Marnie et al. (2017) DNA Priming Increases Frequency of T-Cell Responses to a Vesicular Stomatitis Virus HIV Vaccine with Specific Enhancement of CD8+ T-Cell Responses by Interleukin-12 Plasmid DNA. Clin Vaccine Immunol 24:
Nixon, Daniel E; Bosch, Ronald J; Chan, Ellen S et al. (2017) Effects of atorvastatin on biomarkers of immune activation, inflammation, and lipids in virologically suppressed, human immunodeficiency virus-1-infected individuals with low-density lipoprotein cholesterol <130 mg/dL (AIDS Clinical Trials Group Study A52 J Clin Lipidol 11:61-69
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
Clifford, David B (2017) HIV-associated neurocognitive disorder. Curr Opin Infect Dis 30:117-122
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
Kiser, Jennifer J; Lu, Darlene; Rosenkranz, Susan L et al. (2017) Boceprevir and Antiretroviral Pharmacokinetic Interactions in HIV/HCV Co-infected Persons: AIDS Clinical Trials Group Study A5309s. Drugs R D 17:557-567
Nicholas, Katherine J; Greenplate, Allison R; Flaherty, David K et al. (2016) Multiparameter analysis of stimulated human peripheral blood mononuclear cells: A comparison of mass and fluorescence cytometry. Cytometry A 89:271-80
Robbins, Gregory K; Cohn, Susan E; Harrison, Linda J et al. (2016) Characteristics associated with virologic failure in high-risk HIV-positive participants with prior failure: a post hoc analysis of ACTG 5251. HIV Clin Trials 17:165-72
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
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

Showing the most recent 10 out of 105 publications