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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Moncla, Bernard J; Chappell, Catherine A; Debo, Brian M et al. (2016) The Effects of Hormones and Vaginal Microflora on the Glycome of the Female Genital Tract: Cervical-Vaginal Fluid. PLoS One 11:e0158687
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
Zhou, Tian; Hu, Minlu; Pearlman, Andrew et al. (2016) Expression, regulation, and function of drug transporters in cervicovaginal tissues of a mouse model used for microbicide testing. Biochem Pharmacol 116:162-75
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 :
Coleman, Jenell S; Fuchs, Edward; Aung, Wutyi S et al. (2016) Feasibility of radiolabeled small molecule permeability as a quantitative measure of microbicide candidate toxicity. Contraception 93:331-6
Moncla, Bernard J; Chappell, Catherine A; Mahal, Lara K et al. (2015) Impact of bacterial vaginosis, as assessed by nugent criteria and hormonal status on glycosidases and lectin binding in cervicovaginal lavage samples. PLoS One 10:e0127091
Kramzer, Lindsay F; Cohen, Jessica; Schubert, Jesse et al. (2015) Assessing the potential of the Woman's Condom for vaginal drug delivery. Contraception 92:254-60
Hu, Minlu; Patel, Sravan Kumar; Zhou, Tian et al. (2015) Drug transporters in tissues and cells relevant to sexual transmission of HIV: Implications for drug delivery. J Control Release 219:681-96
Wang, Linlin; Koppolu, Sujeethraj; Chappell, Catherine et al. (2015) Studying the effects of reproductive hormones and bacterial vaginosis on the glycome of lavage samples from the cervicovaginal cavity. PLoS One 10:e0127021
Chappell, Catherine A; Isaacs, Charles E; Xu, Weimin et al. (2015) The effect of menopause on the innate antiviral activity of cervicovaginal lavage. Am J Obstet Gynecol 213:204.e1-6

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