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Population Council #558

Status
Completed
Phase
I
Objective

This Phase 1 clinical trial will evaluate MIV-150, a third generation non-nucleoside reverse transcriptase inhibitor, co-formulated with a potentially potent agent, zinc acetate for the prevention of HIV infection in women. 

Prevention Option(s)
Microbicides
Multipurpose Prevention Technologies
Study Design
Placebo-controlled
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
May 2014
June 2015
Enrollment
35
19
Years
49
Years
Population
Women
Sites

University of Alabama at Birmingham

Birmingham, Alabama
United States of America