CORE A The Overall Program objectives are ambitious and complex: to iteratively, rationally, and expeditiously select a safe and effective combination antiretroviral (ARV) non-vaccine biomedical prevention (nBP) candidate through in vitro, in vivo, and clinical testing, and to establish the capability to manufacture this candidate for future clinical studies. The IPCP-MBP investigators are deeply committed to the development of topical nBP candidates and delivery systems to prevent the sexual transmission of HIV. To meet these goals, the Program must be run by a strong Administrative &Regulatory Core (Core A). The Overall Program PI, Project Leads, and key personnel have significant administrative and regulatory experience, which they bring to successfully complete this project. Success of this IPCP-MBP will rely on Core A to provide scientific, regulatory, and administrative leadership in coordinating the five Scientific Projects, one Scientific Core, and the multiple investigators and sites that make up this IPCP-MBP. Core A will have the primary goals of efficiently facilitating interactions, providing a reliable infrastructure for fiscal management of the Program, providing on-going communications with NIH and the Project Officer as well as the Scientific Advisory Panel (SAP) approved by NIH. It will provide focus for efficient leadership of the overall project by facilitating communication between the Executive Committee (EC) and Steering Committee (SC) members, project investigators, and staff. Core A will also monitor data acquisition and sharing, and coordinate and monitor the exchange of materials and samples between the Projects and Cores, so that the research progresses in an integrated iterative fashion to meet individual project and programmatic milestones. The regulatory aspect of Core A will coordinate with and support the administrative and scientific staff involved in gaining IACUC, IRB, PSRC, and IND approvals required in Projects. It will ensure data from the Exploratory Clinical Trial is properly managed and analyzed and that all GMP and GLP requirements for manufacture and testing in Core B and Project 5 are satisfied and documented.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
1U19AI113048-01
Application #
8765701
Study Section
Special Emphasis Panel (ZAI1-BP-A (M2))
Project Start
Project End
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
1
Fiscal Year
2014
Total Cost
$188,570
Indirect Cost
$28,414
Name
Oak Crest Institute of Science
Department
Type
DUNS #
022470111
City
Pasadena
State
CA
Country
United States
Zip Code
91107
Guthrie, Kate M; Rosen, Rochelle K; Vargas, Sara E et al. (2018) User evaluations offer promise for pod-intravaginal ring as a drug delivery platform: A mixed methods study of acceptability and use experiences. PLoS One 13:e0197269
Vincent, Kathleen Listiak; Moss, John A; Marzinke, Mark A et al. (2018) Phase I trial of pod-intravaginal rings delivering antiretroviral agents for HIV-1 prevention: Rectal drug exposure from vaginal dosing with tenofovir disoproxil fumarate, emtricitabine, and maraviroc. PLoS One 13:e0201952
Medina-Colorado, Audrie A; Vincent, Kathleen L; Miller, Aaron L et al. (2017) Vaginal ecosystem modeling of growth patterns of anaerobic bacteria in microaerophilic conditions. Anaerobe 45:10-18
Gallay, Philippe A; Chatterji, Udayan; Kirchhoff, Aaron et al. (2017) Prevention of vaginal and rectal HIV transmission by antiretroviral combinations in humanized mice. PLoS One 12:e0184303
Churchman, Scott A; Moss, John A; Baum, Marc M (2016) Accurate measurement of female genital tract fluid dilution in cervicovaginal lavage samples. J Chromatogr B Analyt Technol Biomed Life Sci 1017-1018:75-81
Blaser, Martin J; Cardon, Zoe G; Cho, Mildred K et al. (2016) Toward a Predictive Understanding of Earth's Microbiomes to Address 21st Century Challenges. MBio 7:
Moss, John A; Butkyavichene, Irina; Churchman, Scott A et al. (2016) Combination Pod-Intravaginal Ring Delivers Antiretroviral Agents for HIV Prophylaxis: Pharmacokinetic Evaluation in an Ovine Model. Antimicrob Agents Chemother 60:3759-66
Baum, Marc M; Butkyavichene, Irina; Churchman, Scott A et al. (2015) An intravaginal ring for the sustained delivery of tenofovir disoproxil fumarate. Int J Pharm 495:579-587