In-depth: Trials and Tribulations of HIV Prevention Research

GLOBAL: Microbicide research suffers major setback

Photo: Serene Assir/IRIN
Search continues for safe women-friendly microbicides
Nairobi/Johannesburg, 1 February 2007 (PlusNews) - Progress in developing an effective anti-HIV microbicide was dealt a major blow this week when researchers halted trials of a microbicide gel after preliminary results showed it could increase the risk of HIV infection.

The cellulose sulfate trials were stopped after results showed a higher number of infections in the active group compared to the placebo group. The trial was being carried out in Benin (West Africa), India, South Africa and Uganda by the reproductive health research organisation, CONRAD.

Another cellulose sulfate trial, being carried out by US-based Family Health International in Nigeria, has also been halted after the CONRAD findings.

"An independent data monitoring committee, set up to protect the safety of women in trials, found that in the multi-centre trial there was more HIV infection in the active group than in the placebo group," Dr Tim Farley, coordinator of sexually transmitted infection prevention at the United Nations World Health Organisation (WHO), told PlusNews on Thursday. "What it means is unclear at this point, but it was essential to stop the trial."

Farley said the multi-centre study, which started in 2006 and was due to carry on into 2008, involved about 1,300 women. "Lab tests and animal studies showed that it [cellulose sulfate] blocked infection with HIV ... all the safety data showed no risk or harm from the product," he commented. "We will require more investigation into why it is associated with higher HIV infection."

The news has been greeted with shock and disappointment by microbicide advocates and researchers. This is the second failure by a microbicide candidate undergoing trials: in 2000, a large full-scale trial showed that nonoxynol-9, a potential microbicide, was unsafe after women in the study developed a higher risk of HIV infection.

In a joint statement on Wednesday, WHO and UNAIDS said the findings were an "unexpected setback in the search for a safe and effective microbicide that can be used by women to protect themselves against HIV infection".

Manju Chatani, coordinator of the African Microbicides Advocacy Group, stressed that despite the "extreme disappointment", it was important "not to throw out the baby with the bathwater", as microbicide research efforts had to continue.

"This is a terrible thing to have happened, but if we stop microbicide research now, we are defeating the point: [to] create more options for women who don't have enough options to prevent HIV infection," she added. It has been estimated that if 20 percent of women in 73 developing countries used a microbicide that was just 60 percent effective, it would prevent 2.5 million new infections over three years.

Chatani also pointed out that in all the confusion and outrage surrounding the trials, the rights of the women who had become HIV positive during the trials could not be overlooked. "What about the women? We have to make sure that those HIV positive women are getting the care they need."

WHO said other microbicide trials were continuing around the world, and the results of one - conducted in South Africa - were due at the end of 2007.

Microbicides include a range of products - such as gels, films and sponges - that could help prevent the transmission of HIV and other sexually transmitted infections, and are a very female-friendly intervention because women can use them without the knowledge or approval of male sexual partners.

For more information on microbicides:

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