Microbicide Trials Network

MTN-020

Details

Protocol Title: 
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
DAIDS Protocol ID: 
11840
Status: 
Closed to Follow Up

Protocol Chair(s)

Jared Baeten (Protocol Chair)
Thesla Palanee (Protocol Co-Chair)

Description

Use of a VR to provide sustained delivery of microbicides is a novel investigational method for prevention of heterosexual transmission of HIV in women. This drug delivery method may circumvent potential difficulties related to adherence to daily or coitally-dependent uses of microbicide regimens.

 

MTN-020 (ASPIRE) is a Phase 3, multi-site, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of the dapivirine VR (25 mg) for the prevention of HIV-1 infection in healthy, sexually active, HIV-negative women. The study enrolled 2,629 participants who were randomized to receive either the 25 mg dapivirine VR or a placebo VR.  Participants will continue to use the investigational VRs until 120 events (HIV-1 seroconversions) are observed in the trial. It is anticipated that participants will use the study product for a minimum of 12 months.  Following VR use discontinuation, participants will have an additional 4 weeks of follow-up to identify HIV-1 seroconversions that are not detected during the product-use period.  MTN-020 (ASPIRE) is anticipated to be closed to follow-up at the end of June 2015.

Other Study Info

Sponsors:
Division of AIDS, US National Institute of Allergy and Infectious Diseases

US National Institutes of Health

Co-Sponsors:
IPM

Study Design:
Phase 3, multi-site, two-arm, randomized (1:1), double-blind, placebo controlled trial