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. ? ? ADMINISTRATIVE COMPONENT: ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI069534-02
Application #
7341139
Study Section
Special Emphasis Panel (ZAI1-MH-A (M2))
Program Officer
Sachau, Bill R
Project Start
2007-02-01
Project End
2013-12-31
Budget Start
2008-01-01
Budget End
2008-12-31
Support Year
2
Fiscal Year
2008
Total Cost
$1,568,547
Indirect Cost
Name
University of Pennsylvania
Department
Psychiatry
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
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
Bar, Katharine J; Sneller, Michael C; Harrison, Linda J et al. (2016) Effect of HIV Antibody VRC01 on Viral Rebound after Treatment Interruption. N Engl J Med 375:2037-2050
Cillo, Anthony R; Hilldorfer, Benedict B; Lalama, Christina M et al. (2015) Virologic and immunologic effects of adding maraviroc to suppressive antiretroviral therapy in individuals with suboptimal CD4+ T-cell recovery. AIDS 29:2121-9
Tenorio, Allan R; Chan, Ellen S; Bosch, Ronald J et al. (2015) Rifaximin has a marginal impact on microbial translocation, T-cell activation and inflammation in HIV-positive immune non-responders to antiretroviral therapy - ACTG A5286. J Infect Dis 211:780-90
Ramirez, L A; Arango, T A; Thompson, E et al. (2014) High IP-10 levels decrease T cell function in HIV-1-infected individuals on ART. J Leukoc Biol 96:1055-63
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
Grant, Philip M; Kitch, Douglas; McComsey, Grace A et al. (2013) Low baseline CD4+ count is associated with greater bone mineral density loss after antiretroviral therapy initiation. Clin Infect Dis 57:1483-8
Barnabas, Ruanne V; Wasserheit, Judith N; Huang, Yunda et al. (2011) Impact of herpes simplex virus type 2 on HIV-1 acquisition and progression in an HIV vaccine trial (the Step study). J Acquir Immune Defic Syndr 57:238-44