NCT01363037

Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring

Phase 1 Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by healthy women in the United States.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Dapivirine Vaginal Ring	dosage form: dapivirine vaginal ring dosage:25 mg frequency:continuous use duration:28 days
DRUG	Maraviroc Vaginal Ring	dosage form: maraviroc vaginal ring dosage:100 mg frequency:continuous use duration:28 days
OTHER	Placebo Vaginal Ring	dosage form: placebo vaginal ring dosage:N/A frequency:continuous use duration:28 days
DRUG	Dapivirine-Maraviroc Vaginal Ring	dosage form: combination vaginal ring dosage:25 mg dapivirine + 100 mg maraviroc frequency:continuous use duration:28 days

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-06-01
• Last updated: 2015-09-10

Locations

3 sites across 1 country: United States