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Phase III trial of dapivirine ring begins in Africa: New HIV prevention approach for women
Date:7/24/2012

randomly assigned to use either the dapivirine ring or a placebo ring that looks the same but contains no active drug. Participants will be instructed how to insert and remove the ring, which they will replace every four weeks over the course of the one to two years they are in the study. All participants will receive ongoing HIV risk reduction counseling, condoms and diagnosis and treatment of sexually transmitted infections (STIs).

The results of ASPIRE, which are expected late 2014 or early 2015, together with results of The Ring Study, as well as smaller, supporting studies, will form the basis of an application that IPM plans to submit to regulatory authorities seeking approval of the dapivirine ring for widespread use.

"Through IPM's partnership with MTN and NIH, we are able to conduct two pivotal studies in parallel and get the answers we need quickly," said Zeda Rosenberg, Sc.D., chief executive officer of IPM, a nonprofit product development partnership based in Silver Spring, Md. "Regulators usually require results of two large-scale Phase III trials, along with data from other supporting studies, to approve a product for use. This unique collaboration aims to help us make dapivirine ring available as quickly as possible to women in developing countries if it is proven effective and safe for long-term use."

Of the more than 34 million people living with HIV, half are women; and women account for 59 percent of adults with HIV in sub-Saharan Africa, where unprotected heterosexual intercourse is the primary driver of the epidemic. Young women are especially vulnerable; women ages 15 to 24 are up to five times more likely to become infected with HIV than young men. Efforts to promote abstinence, monogamy and the use of male condoms have not been enough to stop the HIV epidemic nor are these practical methods in many settings.

IPM is developing dapivirine for use as a microbicide through a royalty-free licensing agreement w
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Contact: Lisa Rossi
rossil@upmc.edu
412-916-3315
Microbicide Trials Network
Source:Eurekalert

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