The OSUPITTGU Clinical Trials Unit (CTU), composed of 3 Clinical Research Sites (CRSs) at the University of Pittsburgh (PITT CRS) in Pittsburgh, PA, Ohio State University (OSU CRS) in Columbus, Ohio, and Georgetown University (GU CRS) in Washington, DC, proposes to continue its productive affiliations with the AIDS Clinical Trials Group (ACTG) and the Microbicide Trials Network (MTN), contributing scientific and administrative leadership, as well as enrollment and follow-up of participants in a broad range of studies conducted by both Networks. Additionally, the OSUPITTGU CTU is poised to continue its participation as protocol specific sites for studies in the HIV Prevention Trials Network (HPTN) and the HIV Vaccine Trials Network (HVTN), and has capacity to expand further in terms of scientific capabilities and access to both affected and at risk populations. As such, the OSUPITTGU CTU will contribute to the research agendas of several DAIDS HIV/AIDS Clinical Trials Networks and thereby achieve the desired efficiency for a CTU.
The Aims of this application are: 1) to advance the scientific agenda of the ACTG through development and implementation of high-priority research studies focused on HIV Reservoirs and Viral Eradication (HIV Cure), Hepatitis, and End-organ Disease and Inflammation;2) to advance the scientific agenda of the MTN through development and implementation of high-priority research studies on the safety and efficacy of antiretroviral-containing vaginal rings, rectal microbicides, and combination approaches;3) to rapidly expand existing CTU capacity into new areas of HIV and antimicrobial resistance research to meet the evolving needs of DAIDS- and DMID-sponsored Networks;4) to provide access to DAIDS-sponsored trials for hard-to-reach and impoverished populations most impacted by the HIV/AIDS epidemic in western PA, central OH, northern Appalachia, and Washington, DC, where no other access to therapeutic trials exists;5) to recruit, enroll, retain and monitor study participants in high-priority protocols of the ACTG, MTN, HPTN, and HVTN, and meet or exceed performance standards for these Networks;6) to partner with affected communities and community advisory boards at each CRS throughout these endeavors;and 7) to mentor promising young investigators at each CRS to become skilled researchers. The collective expertise, administrative efficiency, and performance record of the OSUPITTGU CTU over the last grant cycle ensure that these Aims are achievable and that the CTU will make important contributions to the research agendas of DAIDS and DMID Networks.

Public Health Relevance

The Pitt-Ohio State-Georgetown Clinical Trials Unit is a collaborative effort that will support the DAIDS HIV/AIDS research networks with a particular focus on critical areas of research in HIV therapy and prevention including: HIV cure, non-infectious comorbidities, hepatitis C, and tuberculosis;HIV prevention strategies including pre-exposure prophylaxis and microbicides;and DMID-sponsored clinical trials for antimicrobial resistant bacteria.

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-RB-A (S2))
Program Officer
Csedrik, Joanne E
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Pittsburgh
Internal Medicine/Medicine
Schools of Medicine
United States
Zip Code
Dooley, Kelly E; Luetkemeyer, Anne F; Park, Jeong-Gun et al. (2014) Phase I safety, pharmacokinetics, and pharmacogenetics study of the antituberculosis drug PA-824 with concomitant lopinavir-ritonavir, efavirenz, or rifampin. Antimicrob Agents Chemother 58:5245-52
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
Kang, Minhee; Hollabaugh, Kimberly; Pham, Vinh et al. (2014) Virologic and serologic outcomes of mono versus dual HBV therapy and characterization of HIV/HBV coinfection in a US cohort. J Acquir Immune Defic Syndr 66:172-80
Zheng, Yu; Hughes, Michael D; Lockman, Shahin et al. (2014) Antiretroviral therapy and efficacy after virologic failure on first-line boosted protease inhibitor regimens. Clin Infect Dis 59:888-96
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
Cranston, Ross D; Hoesley, Craig; Carballo-Dieguez, Alex et al. (2014) A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010). AIDS Res Hum Retroviruses 30:184-9
Cillo, Anthony R; Krishnan, Supriya; McMahon, Deborah K et al. (2014) Impact of chemotherapy for HIV-1 related lymphoma on residual viremia and cellular HIV-1 DNA in patients on suppressive antiretroviral therapy. PLoS One 9:e92118
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
McKinnon, John E; Mailliard, Robbie B; Swindells, Susan et al. (2014) Baseline natural killer and T cell populations correlation with virologic outcome after regimen simplification to atazanavir/ritonavir alone (ACTG 5201). PLoS One 9:e95524
Besson, Guillaume J; Lalama, Christina M; Bosch, Ronald J et al. (2014) HIV-1 DNA decay dynamics in blood during more than a decade of suppressive antiretroviral therapy. Clin Infect Dis 59:1312-21

Showing the most recent 10 out of 13 publications