The primary objective of this Program is to advance an intravaginal ring formulation of a microbicide combination to safely reduce the sexual transmission of HIV. The overall Program includes 3 Projects and a Scientific Core and is comprised of several critical subcontracts that will enable the scientific team to achieve its goals. The interactions between the investigators, laboratories and clinical research sites are essential to the success of this Program. Consequently, a well-organized, well-defined administrative structure is necessary to optimize the success of this endeavor. The Administrative Core will oversee the day-to-day management of the Program and ensure communication and coordination of all study sites. The members of the Administrative Core will work closely with the investigators, pharmaceutical collaborators, NIH representatives and members of the designated Scientific Advisory Panel.
The aims of the Core are to coordinate the fiscal and organizational aspects of the Program. The Core will be responsible for maintaining and reviewing budgets and will facilitate research related travel. In addition, administrative staff will be responsible for ensuring procurement and distribution of candidate microbicides as well as overseeing the shipment of clinical samples between the sites. The Administrative Core staff will arrange all study related confernce calls and annual meetings. The Core will also provide guidance to the Program Director, Project and Core Leaders for smooth, inter-institutional complex interactions, including assistance with subcontracts, IRB, Clinical Research Center and Ethics Committee submissions in New York and Rwanda, and identifying and resolving unanticipated problems.

Public Health Relevance

The goal of this Program is to advance an intravaginal ring formulation of a combination microbicide to safely reduce the sexual transmission of HIV. The Core will coordinate all fiscal and organizational aspects of the Program.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI076980-03
Application #
8307886
Study Section
Special Emphasis Panel (ZAI1)
Project Start
Project End
Budget Start
2011-09-01
Budget End
2012-08-31
Support Year
3
Fiscal Year
2011
Total Cost
$161,303
Indirect Cost
Name
Albert Einstein College of Medicine
Department
Type
DUNS #
110521739
City
Bronx
State
NY
Country
United States
Zip Code
10461
Keller, Marla J; Mesquita, Pedro M; Marzinke, Mark A et al. (2016) A phase 1 randomized placebo-controlled safety and pharmacokinetic trial of a tenofovir disoproxil fumarate vaginal ring. AIDS 30:743-51
Rastogi, Rachna; Su, Jonathan; Mahalingam, Alamelu et al. (2016) Engineering and characterization of simplified vaginal and seminal fluid simulants. Contraception 93:337-346
Teller, Ryan S; Malaspina, David C; Rastogi, Rachna et al. (2016) Controlling the hydration rate of a hydrophilic matrix in the core of an intravaginal ring determines antiretroviral release. J Control Release 224:176-183
Smith, James M; Srinivasan, Priya; Teller, Ryan S et al. (2015) Tenofovir disoproxil fumarate intravaginal ring protects high-dose depot medroxyprogesterone acetate-treated macaques from multiple SHIV exposures. J Acquir Immune Defic Syndr 68:1-5
Srinivasan, Priya; Dinh, Chuong; Zhang, Jining et al. (2014) Pharmacokinetic evaluation of tenofovir disoproxil fumarate released from an intravaginal ring in pigtailed macaques after 6 months of continuous use. J Med Primatol 43:364-9
Teller, Ryan S; Rastogi, Rachna; Johnson, Todd J et al. (2014) Intravaginal flux controlled pump for sustained release of macromolecules. Pharm Res 31:2344-53
Nixon, Briana; Jandl, Thomas; Teller, Ryan S et al. (2014) Vaginally delivered tenofovir disoproxil fumarate provides greater protection than tenofovir against genital herpes in a murine model of efficacy and safety. Antimicrob Agents Chemother 58:1153-60
Herold, Betsy C; Dezzutti, Charlene S; Richardson, Barbra A et al. (2014) Antiviral activity of genital tract secretions after oral or topical tenofovir pre-exposure prophylaxis for HIV-1. J Acquir Immune Defic Syndr 66:65-73
Nixon, Briana; Stefanidou, Martha; Mesquita, Pedro M M et al. (2013) Griffithsin protects mice from genital herpes by preventing cell-to-cell spread. J Virol 87:6257-69
Mesquita, Pedro M M; Srinivasan, Priya; Johnson, Todd J et al. (2013) Novel preclinical models of topical PrEP pharmacodynamics provide rationale for combination of drugs with complementary properties. Retrovirology 10:113

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