NCT01617096

Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,629 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.

Detailed description

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women." MTN-020 will enroll approximately 3676 sexually active HIVnegative women aged 18-45 years randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of dapivirine or a placebo vaginal ring. Rings will be inserted once every 28 days for 12 consecutive months. MTN expects to initiate this study in August 2012.

Conditions

• HIV Infections

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Dapivirine Vaginal Ring	Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months
COMBINATION_PRODUCT	Placebo Ring	Vaginal ring containing no drug substance

Timeline

• Start date: 2012-07-24
• Primary completion: 2015-07-03
• Completion: 2015-12-01
• First posted: 2012-06-12
• Last updated: 2022-12-21
• Results posted: 2022-12-16

Locations

7 sites across 4 countries: Malawi, South Africa, Uganda, Zimbabwe

Regulatory

• FDA-regulated drug study