The University of Rochester Clinical Trials Unit (UR CTU) proposes to conduct HIV/AIDS clinical research with two NIAID HIV/AIDS Clinical Research Networks, 1) the 'Adult HIV Therapeutic Strategies Network' (AHTSN) and 2) the 'Vaccines to Prevent HIV Infection Network' (VPHIN). The CTU will consist of 3 Clinical Research Sites (CRS), two of which will be operated by the 'Infectious Diseases Division' in the Department of Medicine at the University of Rochester; one conducting therapeutic research for the 'AHTSN' and the other conducting vaccine prevention research for the 'VPHIN'. The third CRS will be located at the Baylor College of Medicine (BCM) 'Vaccine Research Center' in the Department of Molecular Virology and Microbiology in Houston, TX and will conduct research for the 'VPHIN'. The CRS conducting therapeutic research for the 'AHTSN' at UR will include collaborating investigators from the University of Buffalo, and AIDS Care, Inc. The CRS conducting vaccine prevention research at BCM will include collaborating investigators from the University of Texas Health Science Center at Houston.
The specific aims of the CTU will be to: 1) Establish and integrate outstanding Clinical Research Sites that conduct clinical trials under the two NIAID Clinical Research Networks (the 'AHTSN' and 'VPHIN') to effectively advance NIAID HIV/AIDS clinical research activities; 2) Provide outstanding scientific, administrative and fiscal leadership that is responsive to the NIAID and 'AHTSN' and 'VPHIN' leadership groups to advance and enhance NIAID HIV/AIDS clinical research activities, and to conduct a continuous evaluation process that optimizes performance of such activities, 3) Provide outstanding infrastructure (including laboratory, pharmacy, regulatory compliance, data management, quality management and staff training) that effectively supports NIAID HIV/AIDS clinical research activities at the UR and BCM, and 4) Stimulate communication and engagement with the full range of communities that the CTU serves, and to promote robust community participation in NIAID HIV/AIDS clinical research activities, which includes the support of well-integrated Community Advisory Boards and community education programs in Rochester and Houston.

Public Health Relevance

The UR CTU will conduct rigorous, high-quality, cost-effective ethical clinical research designed to improve public health by contributing to the establishment of standards-of-care for medical conditions affecting people living with HIV (under the leadership of the NIAID 'Adult HIV Therapeutic Strategies Network') and the development of a safe and effective preventive HIV vaccine (under the leadership of the NIAID 'Vaccines to Prevent HIV Infection Network').

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 #
5UM1AI069511-09
Application #
8784173
Study Section
Special Emphasis Panel (ZAI1-RCU-A (S5))
Program Officer
Tauscher, Gail H
Project Start
2007-02-01
Project End
2020-11-30
Budget Start
2014-12-01
Budget End
2015-11-30
Support Year
9
Fiscal Year
2015
Total Cost
$1,135,210
Indirect Cost
$380,223
Name
University of Rochester
Department
Internal Medicine/Medicine
Type
Schools of Dentistry
DUNS #
041294109
City
Rochester
State
NY
Country
United States
Zip Code
14627
Kalayjian, Robert C; Albert, Jeffrey M; Cremers, Serge et al. (2018) Women have enhanced bone loss associated with phosphaturia and CD4+ cell restoration during initial antiretroviral therapy. AIDS 32:2517-2524
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
Ocque, Andrew J; Hagler, Colleen E; Morse, Gene D et al. (2018) Development and validation of an LC-MS/MS assay for tenofovir and tenofovir alafenamide in human plasma and cerebrospinal fluid. J Pharm Biomed Anal 156:163-169
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
Benson, Constance A; Andersen, Janet W; Macatangay, Bernard J C et al. (2018) Safety and Immunogenicity of Zoster Vaccine Live in Human Immunodeficiency Virus-Infected Adults With CD4+ Cell Counts >200 Cells/mL Virologically Suppressed on Antiretroviral Therapy. Clin Infect Dis 67:1712-1719
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
Riddler, Sharon A; Zheng, Lu; Durand, Christine M et al. (2018) Randomized Clinical Trial to Assess the Impact of the Broadly Neutralizing HIV-1 Monoclonal Antibody VRC01 on HIV-1 Persistence in Individuals on Effective ART. Open Forum Infect Dis 5:ofy242
Elizaga, Marnie L; Li, Shuying S; Kochar, Nidhi K et al. (2018) Safety and tolerability of HIV-1 multiantigen pDNA vaccine given with IL-12 plasmid DNA via electroporation, boosted with a recombinant vesicular stomatitis virus HIV Gag vaccine in healthy volunteers in a randomized, controlled clinical trial. PLoS One 13:e0202753
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:

Showing the most recent 10 out of 110 publications