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 the procurement of non-human primates for studies in Projects 1 and 2 as well as overseeing the shipment of clinical samples between the sites. The Administrative Core staff will arrange all study related conference 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, and Clinical Research Center submissions and identifying and resolving unanticipated problems.

Public Health Relevance

This Program goal is to advance an intravaginal ring formulation of a microbicide combination 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 #
5U19AI103461-02
Application #
8606167
Study Section
Special Emphasis Panel (ZAI1-EC-A)
Project Start
Project End
Budget Start
2014-01-01
Budget End
2014-12-31
Support Year
2
Fiscal Year
2014
Total Cost
$303,868
Indirect Cost
$80,115
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
Herold, Betsy C; Chen, Beatrice A; Salata, Robert A et al. (2016) Impact of Sex on the Pharmacokinetics and Pharmacodynamics of 1% Tenofovir Gel. Clin Infect Dis 62:375-382
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
Buckley, Niall; Huber, Ashley; Lo, Yungtai et al. (2016) Association of High-Risk Human Papillomavirus with Genital Tract Mucosal Immune Factors in HIV-Infected Women. Am J Reprod Immunol 75:146-54
Carias, Ann M; Allen, Shannon A; Fought, Angela J et al. (2016) Increases in Endogenous or Exogenous Progestins Promote Virus-Target Cell Interactions within the Non-human Primate Female Reproductive Tract. PLoS Pathog 12:e1005885
Nakra, Natasha A; Madan, Rebecca Pellett; Buckley, Niall et al. (2016) Loss of Innate Host Defense Following Unprotected Vaginal Sex. J Infect Dis 213:840-7
Petro, Christopher D; Weinrick, Brian; Khajoueinejad, Nazanin et al. (2016) HSV-2 ?gD elicits Fc?R-effector antibodies that protect against clinical isolates. JCI Insight 1:
Irvin, Susan C; Herold, Betsy C (2015) Molecular mechanisms linking high dose medroxyprogesterone with HIV-1 risk. PLoS One 10:e0121135
Fernández-Romero, José A; Deal, Carolyn; Herold, Betsy C et al. (2015) Multipurpose prevention technologies: the future of HIV and STI protection. Trends Microbiol 23:429-436
Petro, Christopher; González, Pablo A; Cheshenko, Natalia et al. (2015) Herpes simplex type 2 virus deleted in glycoprotein D protects against vaginal, skin and neural disease. Elife 4:

Showing the most recent 10 out of 17 publications