From BENEDICT TEMBO in PITTSBURGH, USA
ZAMBIA has been enlisted for the Vaginal and Oral Interventions to Control the Epidemic (VOICE) study, a major HIV prevention trial testing two different approaches for preventing sexual transmission of HIV in women.
VOICE is a tablet and a vaginal microbicide therapy looking at whether some of the same antiretroviral (ARV) medications used successfully for the treatment of HIV are safe and effective for HIV prevention.
Patrick Ndase, regional physician Microbicide Trials Network and Partners Pre-exposure prophylaxis (PREP) Study, University of Washington said Zambia is among four African countries to be an HIV/AIDS Clinical Trial Unit for the Microbicide Trials Network (MTN).
Speaking at the just-ended 2010 Microbicides (M2010) Conference in Pittsburgh, Ndase said Uganda, South Africa and Zimbabwe are the other countries where the study is being conducted.
While VOICE is already underway in South Africa, Uganda and Zimbabwe, Zambia’s investigations have not started because the Centre for Infectious Disease Research in Zambia (CIDRZ) is still waiting for clearance from the Ministry of Health.
The backlash in the aftermath of the mis-representation of the very critical data of the Microbicides Development Programme (MDP) trials in Mazabuka last December has contributed to the hold-up of the CIDRZ study at Kamwala Health Centre in Lusaka.
“The VOICE Study also wants to learn which of these routines women are more likely to follow: taking a tablet by mouth once a day or applying a vaginal microbicide gel every day. This is important because no approach can be truly effective if women are not willing and able to use it,” Ndase said
He said the ARV tablets being tested are called tenofovir and truvada.
“Both are drugs routinely used as part of combination therapy for treating HIV. They are also used to prevent mother-to-child transmission of HIV. The microbicide being tested is called tenofovir gel. It has the same active ingredient as the oral tablet,” he said.
In Zambia, about 300 women are expected to be part of the 5,000 women aged between 18 and 35 who are HIV negative and not pregnant to participate in the trial as volunteers.
“Researchers at the Centre for Infectious Disease Research in Zambia (CIDRZ) hope also to be conducting this study so that Zambian women will have the opportunity to participate,” he said during his presentation on how clinical research works at St. Lawrence Convention Centre on Saturday.
The Research and Ethics Committee of the University of Zambia has endorsed the study, so has the University of Alabama at Birmingham’s school of medicine review board.
VOICE is funded by the US-based National Institutes of Health (NIH).
Women account for over 60 percent of HIV infections in Sub-Saharan Africa and represent one of the largest and fastest growing at-risk populations for HIV, especially in Zambia.
“As such, Zambian women are among those who will benefit most if VOICE or any other trial finds a safe and effective method for preventing HIV,” Ndase said.
VOICE was designed according to the most rigorous international medical practice and ethical standards and includes measures to protect the safety and wellbeing of all participants. Before volunteers can enroll, staff ensure they understand the procedures, risks and benefits of the study, and that they have the right not to participate or to leave the study at any time.
Women who enroll are randomly assigned – like the toss of a coin – 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. VOICE will involve 5,000 women, 1,000 in each group.
Women use the same product every day for the entire study (about two years) but no one knows which tablet or gel.
Because it is not known whether the study approaches will be effective, researchers do everything possible to help prevent women from acquiring HIV. All participants receive ongoing HIV risk-reduction counseling, condoms, and diagnosis and treatment of STIs – proven measures for reducing the risk of HIV.
The M2010 started on May 22 ran up to May 25 at Pittsburgh’s David Lawrence Convention Centre.
Nearly 1,000 participants from 47 different countries attended to hear about the latest developments in HIV prevention research.
M2010 is the sixth biennial meeting of the International Microbicides Conference and marks the first meeting in the United States since the 2000 inaugural gathering in Washington, D.C. Other previous meetings have been in Antwerp, Belgium; London, England; Cape Town, South Africa; and New Delhi, India.