NCT01242579

A Safety and Pharmacokinetic Study for Dapivirine and Maraviroc Gel in Belgium

A Double-Blind, Randomised, Placebo-Controlled Phase I Trial to Compare the Pharmacokinetics of Maraviroc and Dapivirine Following Application of Maraviroc Vaginal Vaginal Gel, 0.1% 2.5g, Dapivirine Vaginal Gel, 0.05%, 2.5g and Maraviroc 0.1% + Dapivirine 0.05% Vaginal Gel, 2.5g Formulations, and to Assess Their Safety as Compared to the Matching Placebo Vaginal Gel, 2.5g in Healthy, HIV-Negative Women

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (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 gel and determine whether it is safe for daily use by healthy women in the United Kingdom

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Maraviroc/Dapivirine Gel	Vaginal gel containing 2.5g - Maraviroc 0.1%, Dapivirine 0.05%
DRUG	Dapivirine Vaginal Gel	Dapivirine vaginal gel containing 2.5g
DRUG	Maraviroc Vaginal Gel	Maraviroc vaginal gel containing 2.5g
DRUG	Matching Placebo Gel	Matching placebo gel containing 2.5g

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-11-17
• Last updated: 2011-09-09