Phase 3 ASPIRE trial completes enrollment
The Microbicide Trials Network announced that it has completed enrollment of its phase 3 clinical trial of the dapivirine vaginal ring, which was designed to prevent HIV infection in women.
Launched in August 2012, the ASPIRE trial is on target to conclude in approximately 1 year, with results expected in late 2015 or early 2016. A total of 2,629 women from 15 sites in Malawi, South Africa, Uganda and Zimbabwe are now taking part in the study.
“This is a tremendous achievement and a testament to the incredible commitment of the teams at each and every trial site,” Jared Baeten, MD, PhD, of the University of Washington and head of the ASPIRE trial, said in a press release. “Importantly, having completed enrollment brings us that much closer to determining whether the dapivirine ring is safe and effective in women, who in many settings face tremendous HIV risk.”
The ASPIRE trial, or MTN-020, is one of two trials studying the efficacy and safety of the dapivirine ring in women. Its sister trial, The Ring Study, is being led by the International Partnership for Microbicides, which developed the product. It began in April 2012 and will enroll almost 2,000 women at seven sites in South Africa and Uganda. That trial is expected to conclude in 2016. The two trials were conducted concurrently to accelerate the product’s potential regulatory approval.
Dapivirine, also known as TMC-120, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). The ring’s silicone material allows the drug to be released over an extended period of time. Some of the women in the ASPIRE trial and all of the women in The Ring Study will wear the vaginal ring monthly for 2 years or longer to study its long-term efficacy.