November 25, 2011

Dear Advocates,

Today, the VOICE trial team announced that the 1% tenofovir gel arm of this five-arm study will close. This update contains links to resources, including AVAC’s statement and information on a global teleconference to help advocates understand this new 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 on Tuesday, 29 November, at time 10am US Eastern (see www.timeanddate.com for the time in your area). The call, which AVAC is hosting along with the Global Campaign for Microbicides and the International Rectal Microbicide Advocates, will be recorded and posted to the AVAC website. If you have a specific question that you’d like to submit in advance, please send it avac@avac.org.

Click here to register for the call and receive dial-in information.

After an interim review of trial data last week, the independent Data Safety and Monitoring Board (DSMB) for VOICE—a five-arm proof-of-concept trial that has enrolled more than 5,000 women in South Africa, Uganda and Zimbabwe—recommended that the 1% tenofovir gel 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 tenofovir gel would show effectiveness in preventing HIV in the context of the VOICE trial. Importantly, the DSMB found no safety issues in any arm of the trial. No other data from the trial have been released at this time. (An earlier DSMB review in September stopped the oral tenofovir arm of the trial after it was determined that oral tenofovir could not be shown effective in the context of this trial. The oral TDF/FTC arm is continuing.)

Additional information from the range of recently completed and ongoing clinical trials, as well as planned demonstration projects, will help guide decisions about the best use of ARV-based prevention methods among different populations. This information will also help answer important questions about the potential for real-world use of these interventions. AVAC will be monitoring these developments closely and will work with researchers and advocates to help understand the implications of recent results.

Additional information about VOICE, including a Questions and Answers document about VOICE can be found at www.mtnstopshiv.org/news/studies/mtn003. For more information on ongoing HIV prevention research and recent results, visit www.avac.org/trials.  

As always, please contact us with any questions!

Best,
AVAC