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RESEARCHERS exploring possibilities of a prevention method that will help protect women from HIV infection are hopeful that the first clinical trials assessing the effectiveness of an Antiretroviral (ARV)-based microbicide gel running in a number of countries including Zimbabwe will yield positive results.
For years, researchers have been trying to develop a microbicide gel that women can use before engaging in sex which would help protect them from HIV infection, against a background of high infection rates among women in southern Africa.
Women account for at least 60% of the total HIV infections in the region and researchers are keen to remove the burden of the disease from them by developing a prevention method they themselves can control.
The development of a female-controlled prevention method comes at a time of increasing concerns that women lack the power to influence their partners to use protection such as condoms leading to higher infection rates.
But this time researchers say they are optimistic about the outcome of the clinical trials now taking place in Zimbabwe and South Africa because it is the first time that an ARV-based microbicide is being tested.
ARVs have already been shown to prolong the lives of those taking them by reducing the viral load.
Zimbabwe is currently conducting a number of studies but researchers are looking forward to the outcome of the Vaginal and Oral Interventions to Control the Epidemic (Voice), a major HIV prevention trial.
The Voice study seeks to establish whether using ARVs either as a vaginal microbicide gel or an oral tablet is safe and effective for HIV prevention.
Two drugs, truvada and tenofovir are being tested in more than 5 000 women between the ages of 18 and 45 from communities with high prevalence rates.
The study is being done by the University of Zimbabwe in collaboration with the University of California-San Francisco (UZ-UCSF)
In South Africa, the Centre for the AIDS Programme of Research in South Africa (Caprisa) at the University of KwaZulu-Natal (UKZN) is currently conducting clinical trials to assess the effectiveness of the tenofovir gel.
The Caprisa study was to test an antiretroviral-based microbicide and it enrolled a total of 900 HIV negative, sexually active women between the ages of 18 to 40 at two clinical research sites.
The study is a collaborative effort between Family Health International, UKZN and the United States-based CONRAD.
It is being funded by the United States Agency for International Development and the South African Department of Science and Technology.
Both the Voice and Caprisa are using the concept of Pre-Exposure Prophylaxis (Prep) where women are given the drugs under study before they actually become infected.
This concept of Prep is used in other diseases such as malaria and has been shown to significantly reduce infections. Researchers are hoping this would also work in HIV prevention.
Results of the Caprisa trial are expected next month at the International Aids Conference in Vienna and the anticipation among researchers was quite evident at the recent International Microbicides Conference in Pittsburgh.
“It’s no longer an issue of whether or not microbicides can prevent infection in women but it’s now a matter of finding the right microbicide that actually works, there has been a high efficacy rate,” said Zeda Rosenberg, CEO of the International Partnership for Microbicides during one of the panel discussions.
“We will have to be patient but I am optimistic that a microbicide that works is just around the corner.
“It may take us a lot of time but I know eventually we will get there.
“The lives of women all over the world and particularly those in southern Africa all depend on this.”
Zimbabwean researcher and co-chair of the UZ-UCSF Voice study, Mike Chirenje said the first results of the ARV-based microbicides by South Africa were very significant to Zimbabwe and the research field.
“We are all eagerly awaiting the results of the Caprisa trial because it has a lot of significance to the Voice study we are doing in Zimbabwe,” Chirenje said.
“However even more important is the fact that these are the first results that we will have on ARV-based microbicides so we are very excited about the outcome of these clinical trials.”
Responding to a question on whether Zimbabwe’s Voice study would be stopped if the Caprisa trials fail, Chirenje said continuing the research would give researchers a learning opportunity.
Salim Abdool Karim, the UKZN pro-vice and director of Caprisa concurred with Chirenje.
“It’s a very anxious time for all of us with the results expected soon,” Karim said.
“ARV-based prevention is a very promising approach but we will just have to wait.
“Women are twice as likely as their male partners to acquire HIV during sex due to a number of reasons that make them more susceptible and they desperately need a method for preventing HIV that they can control themselves.”
Zimbabwe is one of the few sub-Saharan countries that have recorded an annual drop in HIV/Aids infection rates.
In December, the National Aids Council said the infection rate had dropped from 18% in 2006 to 13,75% last year.
BY BERTHA SHOKO, recently in Pittsburgh, USA
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