NNRTI Microbicide Gel

Status:Completed
Phase:I
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
ARMsExperimental
Description4.00 g dosed once daily for 14 days (main study only)
Mode of DeliveryGel
ARMsPlacebo Comparator
Results: A First-in-Human Trial of MIV-150 and Zinc Acetate Co-Formulated in a Carrageenan Gel: Safety, Pharmacokinetics, Acceptability, Adherence and Pharmacodynamics.
Official Code: NCT02033109
Trial Sponsors: Population Council, USAID
Start Date
End Date
March 31, 2014
March 31, 2015
Enrollment:35
Age range: 18 Years ↔ 49 Years
Population:Cisgender Women