The Administrative 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 Administrative Core will 1) provide administrative oversight of the scientific projects and cores in this program, 2) provide fiscal oversight and coordination 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 of the 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 coordination of research activities 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 collaborations with other investigators 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)
Research Program--Cooperative Agreements (U19)
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Special Emphasis Panel (ZAI1)
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Magee-Women's Research Institute and Foundation
United States
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Akil, Ayman; Agashe, Hrushikesh; Dezzutti, Charlene S et al. (2015) Formulation and characterization of polymeric films containing combinations of antiretrovirals (ARVs) for HIV prevention. Pharm Res 32:458-68
Rinehart, Matthew; Grab, Sheila; Rohan, Lisa et al. (2014) Analysis of vaginal microbicide film hydration kinetics by quantitative imaging refractometry. PLoS One 9:e95005
Zhou, Tian; Hu, Minlu; Pearlman, Andrew et al. (2014) Expression and localization of p-glycoprotein, multidrug resistance protein 4, and breast cancer resistance protein in the female lower genital tract of human and pigtailed macaque. AIDS Res Hum Retroviruses 30:1106-16
Akil, Ayman; Devlin, Brid; Cost, Marilyn et al. (2014) Increased Dapivirine tissue accumulation through vaginal film codelivery of dapivirine and Tenofovir. Mol Pharm 11:1533-41
Chappell, Catherine A; Rohan, Lisa C; Moncla, Bernard J et al. (2014) The effects of reproductive hormones on the physical properties of cervicovaginal fluid. Am J Obstet Gynecol 211:226.e1-7
Parsons, Teresa L; Emory, Joshua F; Seserko, Lauren A et al. (2014) Dual quantification of dapivirine and maraviroc in cervicovaginal secretions from ophthalmic tear strips and polyester-based swabs via liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis. J Pharm Biomed Anal 98:407-16
Dezzutti, Charlene S; Uranker, Kevin; Bunge, Katherine E et al. (2013) HIV-1 infection of female genital tract tissue for use in prevention studies. J Acquir Immune Defic Syndr 63:548-54
Zhou, Tian; Hu, Minlu; Cost, Marilyn et al. (2013) Short communication: expression of transporters and metabolizing enzymes in the female lower genital tract: implications for microbicide research. AIDS Res Hum Retroviruses 29:1496-503
Isaacs, Charles E; Xu, Weimin (2013) Theaflavin-3,3'-digallate and lactic acid combinations reduce herpes simplex virus infectivity. Antimicrob Agents Chemother 57:3806-14
Rinehart, Matthew T; Drake, Tyler K; Robles, Francisco E et al. (2011) Time-resolved imaging refractometry of microbicidal films using quantitative phase microscopy. J Biomed Opt 16:120510