NCT00309205

A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium

A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (planned)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Approximately 36 HIV-negative women, aged \>18 and \< 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.

Conditions

• HIV Infections
• HIV-1

Interventions

Type	Name	Description
DRUG	dapivirine (TMC120) vaginal gel

Timeline

• Start date: 2005-12-01
• First posted: 2006-03-31
• Last updated: 2009-09-01

Locations

1 site across 1 country: Belgium