NCT00332995

Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium

Double-blind, Randomized, Placebo Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 From a Vaginal Ring.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (planned)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	dapivirine (TMC120) vaginal ring

Timeline

• Start date: 2005-07-01
• Completion: 2005-08-01
• First posted: 2006-06-02
• Last updated: 2009-09-01

Locations

1 site across 1 country: Belgium