The Administrafive and Protocol Management Core (Core A) of this grant will provide administrative support for the four scientific projects and two scientific cores for the program entitled, """"""""Alternative Formulations of Tenofovir and UC781"""""""". Specifically, the Administrafive Core will 1) provide administrafive oversight of the scientific projects and cores in this program, 2) provide fiscal oversight and coordinafion for the program across all projects and cores, 3) be the primary point of contact between this research program and the NIAID Program Officer in charge ofthe Integrated Preclinical/Clinical Program for HIV Topical Microbicides, 4) plan and coordinate monthly conference calls for the Scientific Steering Committee, 5) establish a Scientific Advisory Panel of outside scientists to attend an annual meeting of the Scientific Steering Committee and NIAID program scientists, and 6) assist Core C with coordinafion of research activifies with corporate partners and CONRAD. In addition, this Core will provide protocol management support for the clinical studies in Projects 3 and 4, and ensure smooth interactions between CONRAD, which holds the proprietary rights to UC781 and tenofovir, the University of Pittsburgh IRB, and the Division of AIDS. This Core, which will be led by Drs. Sharon Hillier and Lisa Rohan, will support all four scientific projects and both scientific cores through the promotion of scientific interactions and collaborafions with other invesfigators engaged in microbicide research.

Public Health Relevance

The Administrative and Protocol Management Core will provide administrative, regulatory and fiscal support for the scientific projects which will support the development of film formulation of UC781 and tenofovir as topical microbicides.

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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Robinson, Jennifer A; Marzinke, Mark A; Bakshi, Rahul P et al. (2017) Comparison of Dapivirine Vaginal Gel and Film Formulation Pharmacokinetics and Pharmacodynamics (FAME 02B). AIDS Res Hum Retroviruses 33:339-346
Beamer, May A; Austin, Michele N; Avolia, Hilary A et al. (2017) Bacterial species colonizing the vagina of healthy women are not associated with race. Anaerobe 45:40-43
Guthrie, K M; Rohan, L; Rosen, R K et al. (2017) Vaginal film for prevention of HIV: using visual and tactile evaluations among potential users to inform product design. Pharm Dev Technol :1-4
Richardson-Harman, Nicola; Parody, Robert; Anton, Peter et al. (2017) Analytical Advances in the Ex Vivo Challenge Efficacy Assay. AIDS Res Hum Retroviruses 33:395-403
Patel, Sravan Kumar; Rohan, Lisa Cencia (2017) On-demand microbicide products: design matters. Drug Deliv Transl Res 7:775-795
Petrina, Melinda A B; Cosentino, Lisa A; Rabe, Lorna K et al. (2017) Susceptibility of bacterial vaginosis (BV)-associated bacteria to secnidazole compared to metronidazole, tinidazole and clindamycin. Anaerobe 47:115-119
Fan, Maria D; Kramzer, Lindsay F; Hillier, Sharon L et al. (2016) Preferred Physical Characteristics of Vaginal Film Microbicides for HIV Prevention in Pittsburgh Women. Arch Sex Behav :
Hu, Minlu; Zhou, Tian; Pearlman, Andrew P et al. (2016) Comparative Expression Analysis of Cytochrome P450 1A1, Cytochrome P450 1B1 and Nuclear Receptors in the Female Genital and Colorectal Tissues of Human and Pigtailed Macaque. BAOJ Pharm Sci 2:
Hu, Minlu; Zhou, Tian; Dezzutti, Charlene S et al. (2016) The Effect of Commonly Used Excipients on the Epithelial Integrity of Human Cervicovaginal Tissue. AIDS Res Hum Retroviruses 32:992-1004
Bunge, Katherine E; Dezzutti, Charlene S; Rohan, Lisa C et al. (2016) A Phase 1 Trial to Assess the Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics of a Novel Dapivirine Vaginal Film. J Acquir Immune Defic Syndr 71:498-505

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