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

l beyond one year, the team determined a target enrollment of 2,600 participants would be sufficient to meet its objectives. Because the ASPIRE protocol was designed to accommodate new information as it becomes available, both the Study Monitoring Committee and the independent Data Safety and Monitoring Board (DSMB) that conducts routine reviews of the study were in agreement with the team. Indeed, at its most recent review on May 31, the DSMB recommended that the study, with 2,555 women enrolled to date, could stop screening new women and close enrollment soon thereafter.

When ASPIRE concludes in June or July 2015, all women will have used their assigned study product (placebo ring or dapivirine ring) for at least one year, a regulatory requirement, and some women will have used the ring two years or longer. (Because one of the main objectives of The Ring Study is to evaluate long-term safety of the ring, all women enrolled in that trial will use the monthly ring for two years.)

IPM will seek regulatory approval and licensure for the ring based on the results of The Ring Study and ASPIRE as well as several smaller safety studies taking place in the United States and Europe. A nonprofit product developer based in Silver Spring, Md., IPM is developing dapivirine for use as a vaginal microbicide in developing countries through a royalty-free licensing agreement with Janssen R&D Ireland.

Dapivirine, also known as TMC-120, belongs to a class of ARVs called non-nucleoside reverse transcriptase inhibitors (NNRTIs) that bind to and disable HIV's reverse transcriptase enzyme, a key protein needed for HIV replication. The dapivirine ring, made of a flexible silicone material, allows the drug to be slowly released from the ring over time. IPM's studies have shown that the ring can deliver dapivirine to vaginal tissue for a month or longer, with minimal concentration elsewhere in the body. Its studies to date have also shown that use of the dapivi
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Contact: Lisa Rossi
rossil@upmc.edu
412-641-8940
Microbicide Trials Network
Source:Eurekalert

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