NCT00303576

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

A Phase I/II Double-Blind, Randomized Study of the Safety, Tolerability and Systemic Absorption of TMC120 Vaginal Microbicide Gel and Matching Placebo in Healthy HIV-Negative Women.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 112 (planned)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	dapivirine (TMC120) vaginal gel

Timeline

• Start date: 2005-10-01
• Completion: 2006-07-01
• First posted: 2006-03-17
• Last updated: 2006-07-31

Locations

4 sites across 3 countries: Rwanda, South Africa, Tanzania