NCT00700284

Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)

Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	placebo vaginal ring	vaginal ring containing no TMC120 (dapivirine)
DRUG	TMC120 (dapivirine) vaginal ring	vaginal ring containing 120 mg TMC120 (dapivirine)

Timeline

• Start date: 2004-10-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2008-06-18
• Last updated: 2009-09-01

Locations

1 site across 1 country: Belgium