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

the timeline to the ring's potential approval.

Vaginal rings are flexible products that fit comfortably high up inside the vagina and provide sustained delivery of active agents over a period of time. Vaginal rings are already used in many countries to deliver hormonal contraception. The dapivirine ring adapts that medical technology as a way to offer women potentially long-acting protection against HIV. It is the first long-acting ARV-based product to enter efficacy testing and the first involving an ARV other than tenofovir or a tenofovir combination. Moreover, unlike tenofovir, dapivirine is not a drug used in the treatment of HIV.

"Perhaps the most attractive aspect about a vaginal ring as an HIV prevention method is that women can use it discreetly and use it up to a month at a time due to the slow release of the medication it contains. If the women in our trial find it easy and practical to use consistently, this will be extremely important, because only if it is used as directed are we able to assess its true effectiveness," said Thesla Palanee, Ph.D., ASPIRE protocol co-chair who also directs the study at her own institution, the Wits Reproductive Health and HIV Institute (Wits RHI) in Johannesburg, South Africa..

ASPIRE is completing enrollment with fewer participants than originally planned. The research team had assumed needing to enroll up to 3,476 women to answer the study's primary questions about safety and effectiveness, a calculation based in part on a background HIV incidence rate of 3.9 percent in trial site communities at the time the protocol was being developed. In March 2013, however, when ASPIRE was already seven months into the study, results were reported of another HIV prevention trial called VOICE indicating the HIV incidence in a very similar population was much higher, at 5.7 percent. Adjusting for both the higher HIV incidence as well as the fact that the study has more women than expected using the ring wel
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Contact: Lisa Rossi
rossil@upmc.edu
412-641-8940
Microbicide Trials Network
Source:Eurekalert

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