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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1AI069439-08
Application #
8609633
Study Section
Special Emphasis Panel (ZAI1-RCU-A (S5))
Program Officer
Welsch, Sue A
Project Start
2007-02-01
Project End
2020-11-30
Budget Start
2013-12-10
Budget End
2014-11-30
Support Year
8
Fiscal Year
2014
Total Cost
$2,446,203
Indirect Cost
$611,116
Name
Vanderbilt University Medical Center
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37212
Goepfert, Paul A; Elizaga, Marnie L; Seaton, Kelly et al. (2014) Specificity and 6-month durability of immune responses induced by DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis 210:99-110
Lennox, Jeffrey L; Landovitz, Raphael J; Ribaudo, Heather J et al. (2014) Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trial. Ann Intern Med 161:461-71
Haas, David W; Kwara, Awewura; Richardson, Danielle M et al. (2014) Secondary metabolism pathway polymorphisms and plasma efavirenz concentrations in HIV-infected adults with CYP2B6 slow metabolizer genotypes. J Antimicrob Chemother 69:2175-82
Frey, Sharon E; Peiperl, Laurence; McElrath, M Juliana et al. (2014) Phase I/II randomized trial of safety and immunogenicity of LIPO-5 alone, ALVAC-HIV (vCP1452) alone, and ALVAC-HIV (vCP1452) prime/LIPO-5 boost in healthy, HIV-1-uninfected adult participants. Clin Vaccine Immunol 21:1589-99
Johnson, Daniel H; Venuto, Charles; Ritchie, Marylyn D et al. (2014) Genomewide association study of atazanavir pharmacokinetics and hyperbilirubinemia in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 24:195-203
Touzard Romo, F; Smeaton, L M; Campbell, T B et al. (2014) Renal and metabolic toxicities following initiation of HIV-1 treatment regimen in a diverse, multinational setting: a focused safety analysis of ACTG PEARLS (A5175). HIV Clin Trials 15:246-60
Kalayjian, Robert C; Wu, Kunling; Evans, Scott et al. (2014) Proteinuria is associated with neurocognitive impairment in antiretroviral therapy treated HIV-infected individuals. J Acquir Immune Defic Syndr 67:30-5
Jacobson, Jeffrey M; Wang, Hongying; Bordi, Rebeka et al. (2014) A randomized controlled trial of palifermin (recombinant human keratinocyte growth factor) for the treatment of inadequate CD4+ T-lymphocyte recovery in patients with HIV-1 infection on antiretroviral therapy. J Acquir Immune Defic Syndr 66:399-406
Safren, Steven A; Biello, Katie B; Smeaton, Laura et al. (2014) Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial. PLoS One 9:e104178
Bronke, Corine; Almeida, Coral-Ann M; McKinnon, Elizabeth et al. (2013) HIV escape mutations occur preferentially at HLA-binding sites of CD8 T-cell epitopes. AIDS 27:899-905

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