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.
US National Institutes of Health
Phase 3, multi-site, two-arm, randomized (1:1), double-blind, placebo controlled trial