Investigators from the Microbicide Trials Network (MTN) today announced key results from the MTN-020 (ASPIRE) study at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, Massachusetts. A companion study from the International Partnership for Microbicides (IPM) called IPM 027 (“The Ring Study”) reported study results as well. Both studies were designed to evaluate the safety and efficacy of a monthly vaginal ring containing dapivirine for HIV-1 prevention.
“The ASPIRE and Ring Study results are an important milestone in the development of tools for HIV prevention”, said Wafaa El-Sadr MD, MPH, HPTN co-principal investigator and professor of epidemiology and medicine at Columbia University. “We applaud the MTN and IPM for their enormous efforts in undertaking these very important studies and all the participants who volunteered for these studies.”
“While the ASPIRE and Ring Study results clearly contribute to our understanding of HIV prevention, we must continue research endeavors to expand our HIV prevention toolkit,” said Myron Cohen, MD, HPTN co-principal investigator and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill.
MTN-020 (ASPIRE) is a Phase 3, multi-site, randomized, double-blind, placebo-controlled clinical study designed to evaluate the safety and efficacy of the 25 mg dapivirine vaginal ring (VR) for the prevention of HIV-1 infection in healthy, sexually active, HIV-negative women. The study enrolled 2,629 participants who were randomized (1:1) to receive either the 25 mg dapivirine VR or a placebo VR. Participants were asked to use the study product for a minimum of 12 months. Following VR use discontinuation, participants underwent an additional four weeks of follow-up to identify HIV-1 seroconversions that were not detected during the product-use period. MTN-020 (ASPIRE) closed to follow-up at the end of June 2015.
IPM 027 (The Ring Study) is a Phase 3, multi-site, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and long-term safety of the dapivirine VR in the prevention of HIV-1 infection in healthy, sexually active, HIV-negative women. The study enrolled approximately 1,950 women at four sites in South Africa and one in Uganda. Data was also collected on the rates of sexually-transmitted infections, HIV-2 infection, and pregnancy occurring during the study as well as the frequency of drug resistance in women who became HIV-1 positive during the trial.