The Administrative Core (Core A) will direct and coordinate several major areas contributing to the activities of the Combination HIV Antiretroviral Rectal Microbicide or CHARM Program. These activities include (1) administrative oversight of the entire program including all Projects and Cores, (2) providing financial oversight of the program, (3) act as primary liaison with the NIAID/DAIDS appointed Program Officer with responsibility for the Integrated Preclinical/Clinical Program for HIV Topical Microbicides U19 Program, (4) coordinate the monthly conference calls for the Steering Committee (SC) and disseminate agendas / meeting minutes in a timely fashion, (5) organize the annual IP/CP meeting, (5) in collaboration with NIAID/DAIDS, establish and provide logistical support for a Scientific Advisory Panel facilitation, and (6) undertake website maintenance, education, publication assistance, library maintenance, and general administrative support. The Core will link the various project leaders and programs as well as integrate the related milestones of each project and ensuring communication between project leaders. The SC, composed of the Principal Investigator and each Project Leader/Associate-Leader, Core Leader/Associate Leader, and select key personnel, will be the central mechanism in assuring communication between Projects, Project sites, and Cores. The Administrative Core will also produce twice-yearly internal progress reports for the SC. These will be available to interested key personnel and the NIH's Scientific Advisory Panel (SAP).

Public Health Relevance

The Administrative Core will be the primary mechanism to provide administrative, logistical, and financial support for the Projects and Cores as they work towards the achievement of their milestones in pursuit of a combination antiretroviral rectal microbicide

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Program--Cooperative Agreements (U19)
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Special Emphasis Panel (ZAI1-BP-A)
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Magee-Women's Research Institute and Foundation
United States
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Hiruy, Hiwot; Fuchs, Edward J; Marzinke, Mark A et al. (2015) A Phase 1 Randomized, Blinded Comparison of the Pharmacokinetics and Colonic Distribution of Three Candidate Rectal Microbicide Formulations of Tenofovir 1% Gel with Simulated Unprotected Sex (CHARM-02). AIDS Res Hum Retroviruses 31:1098-108
Mcgowan, Ian; Cranston, Ross D; Duffill, Kathryn et al. (2015) A Phase 1 Randomized, Open Label, Rectal Safety, Acceptability, Pharmacokinetic, and Pharmacodynamic Study of Three Formulations of Tenofovir 1% Gel (the CHARM-01 Study). PLoS One 10:e0125363
Hladik, Florian; Burgener, Adam; Ballweber, Lamar et al. (2015) Mucosal effects of tenofovir 1% gel. Elife 4:
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Dezzutti, Charlene S; Russo, Julie; Wang, Lin et al. (2014) Development of HIV-1 rectal-specific microbicides and colonic tissue evaluation. PLoS One 9:e102585
McGowan, Ian; Dezzutti, Charlene (2014) Rectal microbicide development. Curr Top Microbiol Immunol 383:117-36
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Chateau, Morgan L; Denton, Paul W; Swanson, Michael D et al. (2013) Rectal transmission of transmitted/founder HIV-1 is efficiently prevented by topical 1% tenofovir in BLT humanized mice. PLoS One 8:e60024
Chateau, Morgan; Swanson, Michael D; Garcia, J Victor (2013) Inefficient vaginal transmission of tenofovir-resistant HIV-1. J Virol 87:1274-7

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