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September 28, 2011

Dear Advocate,

Today, the VOICE trial team announced that the oral tenofovir pill arm of this five-arm study will close. This update contains links and resources, including AVAC’s statement and information on a global teleconference to help advocates understand this development.

Download AVAC’s statement here.

To discuss these results with trial investigators and other key resource people, advocates are invited to join a global teleconference:

Friday, September 30th, at 9am US Eastern (see www.timeanddate.com for the time in your area). Please use this link to register for the call—upon registration you will receive dial-in information. The call will be recorded and posted to the AVAC website, along with a short written summary. If you have a specific question that you’d like to submit in advance, please send it avac@avac.org — and there will of course be extensive time for discussion on Friday’s call.

After an interim review of trial data, the independent Data Safety and Monitoring Board (DSMB) for VOICE—a proof-of-concept trial testing oral TDF/FTC, oral tenofovir and tenofovir gel, which has enrolled more than 5,000 women in South Africa, Uganda and Zimbabwe—has recommended that the oral tenofovir arm of the study be stopped and that the women in that arm exit the trial in a structured process. The DSMB concluded that there was no possibility that daily use of the oral tenofovir pill (TDF, brand name Viread) would show effectiveness in preventing HIV in the context of the VOICE trial.

This result is one of several ARV-based prevention data announcements that have come in the last 18 months. The data on PrEP in women are mixed and require further investigation. AVAC will be monitoring these developments closely and will work with researchers and advocates to help understand the implications of these and other recent results.

For additional resources and information on ongoing and completed PrEP trials please visit avac.org/prep.

Best, AVAC


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