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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
Placebo
Randomized
Double-blind
Arms and Assigned Interventions
Description
Intravaginal 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 Delivery
Gel
Products
PC-1005 gel
ARMs
Experimental
Description
4.00 g dosed once daily for 14 days (main study only)
Mode of Delivery
Gel
Products
HEC gel
ARMs
Placebo 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
March 2014
March 2015
Enrollment
35
18
Years
49
Years
Population
Women
Sites

University of Alabama at Birmingham

Birmingham, Alabama
United States of America