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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) was 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 used the investigational VRs until 120 events (HIV-1 seroconversions) were observed in the trial. It was anticipated that participants would use the study product for a minimum of 12 months. Following VR use discontinuation, participants had an additional 4 weeks of follow-up to identify HIV-1 seroconversions not detected during the product-use period.

MTN-020 (ASPIRE) completed follow-up on June 25, 2015. Primary results were presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) held on February 22-25, 2016 in Boston, MA. The primary manuscript was published in the New England Journal of Medicine on February 22, 2016.

Protocol Chair(s)
Baeten, Jared (Protocol Chair)
Palanee-Phillips, Thesla (Protocol Co-Chair)
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
Participants off Study and Primary Analysis Completed
Formulation
Vaginal Ring
Drug
Dapivirine
Placebo
Study Focus/Product Administration
Vaginal
Study Type
Behavioral
Efficacy
Safety
Study Phase
Phase III
Countries
Malawi
South Africa
Uganda
Zimbabwe
Population
Women (cisgender women, non‐transgender women)
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institutes of Health
Sponsor(s)
IPM
Other Study Info

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