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 """"""""smart"""""""" suppository device will be developed that will respond to environmental changes to beideal for either vaginal or rectal delivery. The DuoGel development will comprise the formulation of a singleIQP-0528 product and the combination IQP-0528/TFV product through rheological, anti-viral, in-vitro, and exvivo toxicity and safety evaluations based on selection criteria defined by Core B (gel PK and gel spreading). Core C (microbicide efficacy and dosing), and Project 2 (API concentration from MTSA). The smart suppository will be developed to respond to the changing pH differences in the vagina and rectum through pH sensitive nanoparticles that will release pH maintaining salts to prompt ideal environment for drug delivery. Iterative evaluations between Project 1, Core B and Core C will identify a gel and suppository formulation to be moved forward in animal trials (Project 3).

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.

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-ESB-A)
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Imquest Biosciences
United States
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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