This application from the University of Pittsburgh proposes an HIV/AIDS Clinical Trials Unit (Pitt CTU)consisting of two Clinical Research Sites (CRS), one at the University of Pittsburgh affiliated with the AIDS Clinical Trials Group (ACTG) and the Microbicide Trials Network (MTN), and one at Georgetown University affiliated with the ACTG. Both Networks have selected the Pitt CTU for affiliation. The Pitt CTU began conducting HIV/AIDS clinical trials in 1986 and has since acquired broad experience in Phase I-IV studies. Under the leadership of J. Mellors (PI), the Pitt CTU became a DAIDS-funded ACTG Unit in 2000. The Georgetown University CRS joined the Pitt CTU in 2001 and remains the only access to DAIDS-sponsored treatment trials in Washington, DC. The Pitt CTU has been a top performing site in the ACTG over the past three years, ranking 5th out of 34 sites in cost efficiency (cost per weighted accrual) and9th of 34 sites in weighted accrual, with consistently outstanding scores for data management. This strong performance has continued during the current evaluation period (July 2004 - June 2005), with the Pitt CTU ranking 3rd of 34 sites in total accrual, 5th in cost efficiency, 8th in accrual of women, and 4th in data performance. Both the Georgetown and Pitt sites are responsible for this excellent performance. In addition, Pitt CTU investigators have made important contributions to the scientific accomplishments of the ACT G through protocol development, membership on scientific committees, and publication of research findings.
The specific aims of the Pitt CTU for this application are: 1) to provide access to DAIDS-sponsored clinical trials for difficult-to-reach populations heavily impacted by the HIV/AIDS epidemic in Washington, DC, and in rural and urban areas of western Pennsylvania and West Virginia, where no other access exists;2) to recruit, screen, and enroll a minimum of 420 participants during the project period in trials addressing the priority areas of translational research and drug development, optimization of clinical management, therapeutic vaccine research and development, and microbicides;3) to advance the scientific agenda of both Networks by developing research protocols, serving on scientific and leadership committees, and directing virology and immunology specialty laboratories;4) to involve and mentor new investigators in HIV/AIDS clinical research;and 5) to partner with the community throughout these endeavors. The investigators and staff of the Pitt CTU are committed to the goal of reducing the impact of the HIV/AIDS epidemic worldwide through translational research to define optimal strategies for treatment and prevention of HIV-1 infection and its complications. ADMINISTRATIVE COMPONENT:

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI069494-04
Application #
7743574
Study Section
Special Emphasis Panel (ZAI1-DDS-A (M1))
Program Officer
Csedrik, Joanne E
Project Start
2007-02-01
Project End
2013-11-30
Budget Start
2009-12-01
Budget End
2010-11-30
Support Year
4
Fiscal Year
2010
Total Cost
$2,768,591
Indirect Cost
Name
University of Pittsburgh
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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
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
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
Gupta, Samir K; Yeh, Eunice; Kitch, Douglas W et al. (2017) Bone mineral density reductions after tenofovir disoproxil fumarate initiation and changes in phosphaturia: a secondary analysis of ACTG A5224s. J Antimicrob Chemother 72:2042-2048
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
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
Tassiopoulos, Katherine; Abdo, Mona; Wu, Kunling et al. (2017) Frailty is strongly associated with increased risk of recurrent falls among older HIV-infected adults. AIDS 31:2287-2294
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

Showing the most recent 10 out of 105 publications