The VOICE Study: Vaginal and Oral Interventions to Control the Epidemic
· VOICE – Vaginal and Oral Interventions to Control the Epidemic – is a major HIV prevention trial testing whether antiretroviral (ARV) medicines commonly used to treat people with HIV are safe and effective for preventing sexual transmission of HIV in women. Two different ARV-based approaches are being tested in VOICE: daily use of an ARV tablet – an approached called oral pre-exposure prophylaxis, or PrEP – and daily use of a vaginal microbicide containing an ARV in gel form.
· VOICE is the first effectiveness study of a vaginal microbicide that is used every day instead of around the time of sex and it is the only trial testing both an oral tablet and a vaginal gel in the same study. This is important for understanding which approach women are more likely to use.
· Researchers designed VOICE so that three different ARV-based products could be evaluated: oral tenofovir tablets, oral Truvada® tablets, and tenofovir gel, which has the same active ingredient as the oral tablet. Oral tenofovir, known by the brand name Viread®, and Truvada, a combination tablet that contains tenofovir and emtricitabine, are both approved for the treatment of HIV when used in combination with other ARVs.
· VOICE is funded by the U.S. National Institutes of Health and being conducted by the Microbicide Trials Network at 15 sites in Uganda, South Africa and Zimbabwe. As co-sponsors of the trial, CONRAD and Gilead Sciences, Inc., are providing the study products for free.
· The study began in September 2009, completed enrollment of 5,029 women (exceeding its target of 5,000) in June 2011 and is on track to start exiting participants in January 2012 and complete the process before the end of May 2012. After the last women are followed for an additional eight weeks, researchers will begin analysis of study data, with results anticipated early 2013.
· When women enrolled, they were randomly assigned to one of five study groups, either to one of the three tablet groups: tenofovir, Truvada, or oral placebo (a tablet that looks the same but has no active medicine); or to one of the two gel groups: tenofovir gel or placebo gel. Women were asked to use their assigned study product every day for the entire study. All participants receive ongoing HIV risk-reduction counseling, condoms, and diagnosis and treatment of sexually transmitted infections (STIs) – standard measures for reducing the risk of HIV.
· VOICE includes numerous measures to monitor and protect the safety and wellbeing of participants, including interim reviews of data by an independent group called a Data Safety and Monitoring Board (DSMB). A DSMB can recommend that a trial, or part of a trial, be stopped if there are concerns about safety, compelling evidence for a product’s effectiveness or if it is clear that a product is not effective in the study’s participants.
· Based on an interim review conducted in September 2011, VOICE is no longer testing 
tenofovir tablets. That review, the study’s fifth, found oral tenofovir tablets were no better than a placebo for preventing HIV in the women assigned to that study group. The DSMB had no concerns about the safety of any of the study products, including the oral tenofovir tablet.
tenofovir tablets. That review, the study’s fifth, found oral tenofovir tablets were no better than a placebo for preventing HIV in the women assigned to that study group. The DSMB had no concerns about the safety of any of the study products, including the oral tenofovir tablet.· VOICE continues to evaluate the safety and effectiveness of oral Truvada and tenofovir gel. Another routine interim review of VOICE is scheduled to take place on 17 November 2011.
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28-October-2011
See Also
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