NNRTI Microbicide Gel

Principal Investigator(s):Craig J Hoesley, MD
Objective:To assess the safety and pharmacokinetics of an NNRTI microbicide gel in HIV-negative women.
Prevention Option(s):Microbicides
Study Design:Controlled, Double-blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionIntravaginal use: 4.00 g dosed once daily for 3 days (safety run-in) 4.00 g dosed once daily for 14 days (main study)
Mode of DeliveryGel
Description4.00 g dosed once daily for 14 days (main study only)
Mode of DeliveryGel
ARMsPlacebo Comparator
Official Code: NCT02033109
Trial Sponsors: Population Council, USAID
Start Date
End Date
March 31, 2014
March 31, 2015
Age range: 18 Years ↔ 49 Years
Population:Cisgender Women