ARLINGTON, VIRGINIA (12:15 EST MARCH 4, 2013) Researchers with the Microbicide Trials Network (MTN) today announced results of the Vaginal and Oral Interventions to Control the Epidemic (VOICE) study at the Conference for Retroviruses and Opportunistic Infections (CROI) in Atlanta, Georgia. The VOICE study tested oral and vaginal antiretroviral-based approaches as HIV prevention methods in 5,029 women in South Africa, Uganda, and Zimbabwe. Funded by the U.S. National Institutes of Health and managed by the MTN, the VOICE study was a major undertaking, which has provided important data regarding drug safety, effectiveness, acceptability and adherence.
"The principal investigators of the study, Drs. Jeanne Marazzo and Zvavahera Mike Chirenje, and the entire VOICE team have done an outstanding job," said CONRAD Executive Director Gustavo Doncel, M.D., Ph.D.
VOICE launched in September 2009 as a Phase IIB safety and effectiveness study to compare 3 different once-daily HIV prevention strategies: 1) a pill of combination emtricitabine and tenofovir (Truvada), 2) a pill containing only tenofovir (Viread), and 3) tenofovir 1% vaginal gel. Study participants received ongoing HIV risk-reduction counseling, condoms, and diagnosis and treatment of sexually transmitted infections throughout the trial. They were tested monthly for HIV and quarterly for drug levels.
In an evaluation of plasma samples in a subset of the women, drug was detected on average in 28% of participants taking oral tenofovir, 29% of participants taking oral Truvada, and 23% of participants in the vaginal gel study arm. Unfortunately, due to the low adherence, none of the products were deemed effective in reducing HIV acquisition in this particular trial. The estimates of effectiveness for both oral tenofovir and Truvada were less than zero. The study showed a 14.7% reduction of HIV infection in the tenofovir gel arm, when compared to placebo gel. This level of protect
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