Low adherence linked with frequent dosing and narrow therapeutic duration has emerged as the major reason for inconsistent effectiveness outcomes with topical PrEP in clinical trials. Osmotic pumps can achieve versatile drug release profiles with medium durations but have not been explored for vaginal delivery. We have investigated an intravaginal osmotic pump tablet (ivagOPT) that delivers drug consistently and can be configured to provide a bolus dose upon coitally associated pH increase (1). We have also investigated a non-pH sensitive ivagOPT for multiday delivery of a potent antiretroviral, IQP-0528 in a sheep model. We believe this system is an interesting intermediate duration delivery system that deserves further investigation. Furthermore, the major risk of this system is retention in the vagina for the duration of the device. The tablet may simply come out of the introitus under squeezing induced pressure and flows. We felt it was important to test this in a primate model that has similar anatomy and physical orientation as a human and therefore we propose a small Rh. macaque retention and PK study.
|Effective start/end date||11/1/15 → 12/31/17|
- CONRAD Program (MAPS2-15-056//AID-OAA-A-14-00010)
- Agency for International Development (MAPS2-15-056//AID-OAA-A-14-00010)