Hopeful that some of the same antiretroviral (ARV) drugs used to treat HIV infection can also prevent it, researchers from the Microbicide Trials Network have enrolled the first participants into a new, large-scale clinical trial testing two approaches of the strategy in women.
The VOICE Study - Vagina and Oral Interventions to Control the Epidemic - will help determine whether applying a vaginal microbicide gel containing an ARV every day or taking an oral ARV tablet once a day can reduce a woman's risk of acquiring HIV.
While the study's primary aim is to evaluate the safety and effectiveness of the two regimens, an important question VOICE will also address is which of the two - the tablet or the gel - women will actually be more inclined to use. It is the first HIV prevention trial testing these two different approaches in the same study and the first effectiveness trial of a microbicide in which women use the gel every day instead of only at the time of sex.
Up to 5,000 women will be enrolled in VOICE at clinical trial sites in Uganda, South Africa, Zambia and Zimbabwe. Pending government approval, the study may also be conducted in Malawi. The Spilhaus Clinical Research Site at the University of Zimbabwe-University of California-San Francisco (UZ-UCSF) Clinical Trials Unit in Harare, began enrolling trial participants this week.
VOICE is being conducted under the leadership of the U.S. National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), which is based at the University of Pittsburgh and Magee-Womens Research Institute.
"The HIV prevention field has not been without its share of disappointments. So, naturally we are excited that in VOICE we have not just one, but two promising approaches to evaluate. Hopefully, we'll find that ARVs, which helped turn the tide in the treatment of HIV, can be a prevention powerhouse, too," said Mike Chirenje, M.D., FRCOG, associate professor and consultant gynecologist in the department of obstetrics and gynecology at the University of Zimbabwe in Harare and co-chair of the VOICE Study.
Women represent nearly 60 percent of adults living with HIV in sub-Saharan Africa, and in several southern African countries young women are at least three times more likely to be HIV-positive than young men. In most cases, women acquire HIV through sexual intercourse with an infected male partner.
Although correct and consistent use of male condoms has been shown to prevent HIV infection, women often cannot control if or when condoms are used by their male partners. Moreover, women are twice as likely as their male partners to acquire HIV during unprotected sex, due in part to biological factors that make them more susceptible to infection.
"Women need safe and effective methods for preventing HIV that they can control themselves. Importantly, women need methods that they are willing and able to use, because no approach can be truly effective if she leaves it in her purse or hidden in a drawer," added Jeanne Marrazzo, M.D., M.P.H., associate professor of medicine in the division of allergy and infectious diseases at the University of Washington in Seattle, U.S.A., and VOICE Study co-chair with Dr. Chirenje.
Two ARV tablets are being tested in VOICE: tenofovir and Truvada-. Tenofovir, short for tenofovir disoproxil fumarate (TDF), is also known by the brand name Viread-, while Truvada is the brand name for a combination drug that contains tenofovir and another active ingredient called emtricitabine (FTC). Both are approved for treating HIV as part of antiretroviral therapy (ART). While at least three ARVs are typically used for ART, a single ARV tablet taken once a day is the regimen being tested for HIV prevention in current trials, including VOICE, an approach called pre-exposure prophylaxis (PrEP).