In this application we propose the establishment of the University of Pennsylvania Prevention Clinical Trials Unit. Building upon a 12 year history of successful involvement in NIAID funded Networks (Project Jumpstart, HIVNET, and HPTN) we are applying for collaborations with three of the proposed leadership groups: Vaccines, HPTN, and Microbicides. Reflecting this connection to existing networks we are submitting transition budgets for three ongoing NIAID sponsored clinical trials: HPTN 037 (HPTN);HPTN035 (MTCT);and HVTN (502) as a component of this application. The research team of the PENN Prevention CTU includes investigators with a long history of collaboration and scientific contribution at the local, national and international level. Investigators have served in leadership positions on the HIVNET Scientific Steering Committee (member), the HPTN Protocol Review Committee (member), and the HPTN Substance Use Working Group (Chair). Our site is listed as a preferred site in each of the three networks with which we seek Investigators are also listed key personnel in two of the proposed leadership group applications (Microbicides and HPTN). The PENN Prevention CTU will be fully integrated with the PENN Therapeutics CTU (ACTG) and the CHOP CTU (IMPACT). We will expand our current collaborations with investigators from these CTUs and have developed organizational structures that will result in efficiencies across Networks and CTUs including the use of shared laboratory, pharmacy, training, and QA/QC resources. A Scientific Advisory Board will connect our CTUs to the scientific expertise available on campus. The HIV epidemic in Philadelphia provides an important opportunity to conduct prevention science. Our site continues to develop strategies designed to access high risk populations necessary to contribute to the completion of the proposed scientific agendas of the three networks. We are proposing a Clinical Research Site in the Ukraine where the study team has an impressive record of recruiting high incidence cohorts. The Prevention Community Advisory Board (CAB) has been meeting on a monthly basis since 1993. Members of this CAB have a long history of participation in prevention research through the conduct of community and participant education initiatives and service on numerous protocol teams.

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-MH-A (M2))
Program Officer
Bupp, Jane E
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Pennsylvania
Schools of Medicine
United States
Zip Code
Abdel-Mohsen, Mohamed; Kuri-Cervantes, Leticia; Grau-Exposito, Judith et al. (2018) CD32 is expressed on cells with transcriptionally active HIV but does not enrich for HIV DNA in resting T cells. Sci Transl Med 10:
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
MacBrayne, Christine E; Marks, Kristen M; Fierer, Daniel S et al. (2018) Effects of sofosbuvir-based hepatitis C treatment on the pharmacokinetics of tenofovir in HIV/HCV-coinfected individuals receiving tenofovir disoproxil fumarate. J Antimicrob Chemother 73:2112-2119
Salantes, D Brenda; Zheng, Yu; Mampe, Felicity et al. (2018) HIV-1 latent reservoir size and diversity are stable following brief treatment interruption. J Clin Invest 128:3102-3115
Tebas, Pablo; Roberts, Christine C; Muthumani, Kar et al. (2017) Safety and Immunogenicity of an Anti-Zika Virus DNA Vaccine - Preliminary Report. N Engl J Med :
Koenig, H C; Mounzer, K; Daughtridge, G W et al. (2017) Urine assay for tenofovir to monitor adherence in real time to tenofovir disoproxil fumarate/emtricitabine as pre-exposure prophylaxis. HIV Med 18:412-418
George, Varghese; Harrison, Linda; Roach, Margaret et al. (2017) Associations of Plasma Cytokine and Microbial Translocation Biomarkers With Immune Reconstitution Inflammatory Syndrome. J Infect Dis 216:1159-1163
Beigel, John H; Bao, Yajing; Beeler, Joy et al. (2017) Oseltamivir, amantadine, and ribavirin combination antiviral therapy versus oseltamivir monotherapy for the treatment of influenza: a multicentre, double-blind, randomised phase 2 trial. Lancet Infect Dis 17:1255-1265
Buckingham, Lindsey; Becher, Julie; Voytek, Chelsea D et al. (2017) Going social: Success in online recruitment of men who have sex with men for prevention HIV vaccine research. Vaccine 35:3498-3505
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 61 publications