NCT00799058

A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE I/II TRIAL TO EVALUATE THE SAFETY OF DAPIVIRINE GEL 4759, 0.05% 2.5g AND DAPIVIRINE GEL 4789, 0.05% 2.5g FORMULATIONS AS COMPARED TO THE VAGINAL HEC-BASED UNIVERSAL PLACEBO GEL, 2.5g IN HEALTHY HIV-NEGATIVE WOMEN

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women

Detailed description

This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months at five research centers in the USA among 180 healthy, sexually active women, to assess the safety and acceptability of dapivirine Gel 4759, 0.05% 2.5 g, and dapivirine Gel 4789, 0.05% 2.5 g, both vaginal microbicides containing dapivirine, compared to the vaginal HEC-based Universal placebo gel, 2.5 g, containing no active ingredient, used once daily for a period of 12 weeks.

Conditions

• HIV-1 Infections

Interventions

Type	Name	Description
DRUG	dapivirine 4789	dapivirine gel 4789, 0.05%, 2.5g applied once daily
DRUG	dapivirine gel 4759	dapivirine gel 4759, 0.05%, 2.5g applied once daily
DRUG	Drug placebo	HEC-based universal placebo gel, 2.5g applied once daily

Timeline

• Start date: 2009-07-06
• Primary completion: 2011-01-08
• Completion: 2011-01-08
• First posted: 2008-11-27
• Last updated: 2022-10-25
• Results posted: 2022-10-25

Locations

5 sites across 1 country: United States