NCT00917891

An Expanded Safety Study of Dapivirine Gel 4759 in Africa

A Double-blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4759, 0.05%, 2.5g, a Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy, HIV-Negative Women.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 280 (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 determine whether dapivirine gel 4759 is safe for daily use by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.

Detailed description

To reduce the influence of adherence as a factor in the interpretation of efficacy results, IPM is considering using a DOT (Directly Observed Therapy) based method for vaginal microbicide gel delivery in a future Phase III study. IPM has denoted this DOT based method as Daily Monitored Adherence (DMA). IPM014A is a Phase I/II study designed: (1) to assess and compare the safety of a once daily application of Dapivirine Gel 4759, 0.05% 2.5g and a matching vehicle placebo gel; (2) to assess the acceptability of a once daily application of Dapivirine gel 4759, 0.05% 2.5g and a matching vehicle placebo gel; and (3) to assess the feasibility of utilizing the DMA method for a large-scale phase III efficacy study.

Conditions

• HIV Infections
• Acquired Immunodeficiency Syndrome

Interventions

Type	Name	Description
DRUG	dapivirine	dosage form: vaginal gel dosage: 1.25mg dapivirine/day frequency: once daily duration: 6 weeks
DRUG	placebo	dosage form: vaginal gel frequency: once daily duration: 6 weeks

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-01-01
• Completion: 2011-09-01
• First posted: 2009-06-10
• Last updated: 2011-09-12

Locations

10 sites across 5 countries: Kenya, Malawi, Rwanda, South Africa, Tanzania