As the practice of receptive anal intercourse is not limited to men who have sex with men (MSM), and there is clear evidence of both receptive vaginal and anal intercourse in the same sexual act, there is a strong rationale for the development of a microbicide formulation that is suitable for both rectal and vaginal application. A dual compartment microbicide formulation will reduce the complexity of maintaining separate dosage forms for women who engage in both anal and vaginal sex. With the promising development of the IQP-0528/TFV combination vaginal gel, a novel dual vaginal and rectal gel (DuoGel) will be developed in Project 1 from the preexisting gel formulation. In addition, to directly address potential issues of user acceptability and physiological differences between the vagina and rectum in a dual chamber microbicide product, a

Public Health Relevance

The produced DuoGel microbicides will provide an HIV-1 preventative strategy to directly address the growing concerns of both vaginal and receptive anal intercourse as a means of HIV transmission. Additionally, the smart suppositories will provide an alternative dosage form to address regional preferences and potential issues between vaginal and rectal drug delivery.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
1U19AI101961-01
Application #
8404124
Study Section
Special Emphasis Panel (ZAI1-ESB-A (M2))
Project Start
2012-06-22
Project End
2017-05-31
Budget Start
2012-06-22
Budget End
2013-05-31
Support Year
1
Fiscal Year
2012
Total Cost
$295,990
Indirect Cost
$48,244
Name
Imquest Biosciences
Department
Type
DUNS #
146051664
City
Frederick
State
MD
Country
United States
Zip Code
21704
Pereira, Lara E; Mesquita, Pedro M M; Ham, Anthony et al. (2016) Pharmacokinetic and Pharmacodynamic Evaluation following Vaginal Application of IQB3002, a Dual-Chamber Microbicide Gel Containing the Nonnucleoside Reverse Transcriptase Inhibitor IQP-0528 in Rhesus Macaques. Antimicrob Agents Chemother 60:1393-400
Gao, Y; Yuan, A; Chuchuen, O et al. (2015) Vaginal deployment and tenofovir delivery by microbicide gels. Drug Deliv Transl Res 5:279-94
Ham, Anthony S; Nugent, Sean T; Peters, Jennifer J et al. (2015) The rational design and development of a dual chamber vaginal/rectal microbicide gel formulation for HIV prevention. Antiviral Res 120:153-64
Katz, David F; Yuan, Andrew; Gao, Yajing (2015) Vaginal drug distribution modeling. Adv Drug Deliv Rev 92:2-13