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ASPIRE Phase III trial of vaginal ring to prevent HIV completes enrollment of 2,629 women
Date:6/26/2014

PITTSBURGH, June 26, 2014 ASPIRE, one of two Phase III trials of a promising method for preventing HIV in women a vaginal ring worn for a month at a time has completed enrollment of participants, with 2,629 women from 15 clinical research sites in Malawi, South Africa, Uganda and Zimbabwe now taking part in the study. ASPIRE, a flagship study of the Microbicide Trials Network (MTN), and its sister trial, The Ring Study, which is being led by the International Partnership for Microbicides (IPM), are the first to evaluate the effectiveness of a vaginal ring for HIV prevention. Both studies are testing a vaginal ring that contains an antiretroviral (ARV) drug called dapivirine.

In reaching this milestone, ASPIRE A Study to Prevent Infection with a Ring for Extended Use, also known as MTN-020, is on target to conclude about one year from now with results expected by late 2015 or early 2016. The study was launched in August 2012.

"This is a tremendous achievement and a testament to the incredible commitment of the teams at each and every trial site. 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," said Jared Baeten, M.D., Ph.D., of the University of Washington, who as protocol chair is leading the trial for the MTN, both of which are funded by U.S. National Institutes of Health (NIH).

The dapivirine ring was developed by IPM, which is also the regulatory sponsor and license holder of the product. IPM's The Ring Study, also known as IPM 027, began in April 2012 and will enroll approximately 1,950 women at seven sites in South Africa and Uganda. It is expected to conclude in and have results by 2016. Because at least two Phase III efficacy trials are usually needed for a product to be considered for regulatory approval, IPM and MTN partnered to run the two sister studies concurrently to accelerate
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Contact: Lisa Rossi
rossil@upmc.edu
412-641-8940
Microbicide Trials Network
Source:Eurekalert

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