drugset / Trial / NCT00303576

A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel

NCT00303576

Phase 1/2 Completed 112 enrolled International Partnership for Microbicides, Inc.
RandomizedParallel-groupDouble-blindPrevention

Summary

Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel. The volunteers will receive investigational product for a total of 42 days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.

Timeline

Start
2005-10
Primary completion
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject dapivirine Small molecule Other