State to run trials of anti-HIV gel

15 June 2011 - 00:10 By HARRIET MCLEA

Deputy Minister of Science and Technology Derek Hanekom said at a briefing on the launch of the Facts001 clinical trials yesterday that discussions were already under way for "the possibility of making it as freely available as condoms are available".

Before the microbicide gel called Tenofovir can be distributed to women , its efficacy must be tested in another trial. It is hoped it would be on the market by 2014.

Hanekom said once researchers were "quite sure that it is effective", the gel would be "put onto the market as soon as possible".

"We are looking at local manufacture - for South Africa and sub-Saharan Africa," he said, suggesting a public-private partnership.

"A challenge would be to put it on the market as affordable as possible," Hanekom said.

The previous trial of the Tenofovir gel, then known as Caprisa, proved that it was 39% effective at preventing HIV infection in women when applied to their vagina 12 hours before and after having sex.

But chief researcher of the Facts001 trial and executive director of the Wits University Reproductive Health and HIV Institute, Professor Helen Rees, said the next trial results could be even more promising.

"Because [Caprisa] was a small study, the confidence intervals were very wide. It could be much higher or lower," she said.

About 2200 HIV-negative women between the ages of 18 and 30, who are not considering becoming pregnant in the next two years, will be recruited for this new two-year trial run at sites in Cape Town, Durban, Johannesburg, Ga-Rankuwa, Soweto, Soshanguve and Rustenburg.

The R300-million trial has been funded by the Departments of Science and Technology and Health, and USAid.

Previous trials of other gels, Rees said, revealed that participants - particularly menopausal women - enjoyed using the gel as a lubricant.

"The big message that we got is that women like it," she said.

Rees said it was possible that if the gel is approved by the Medicines Control Council, it could be also be marketed as a lubricant that is "partially effective at preventing HIV".

Though two years were allocated for the trial, it could "stop earlier if assumptions are correct about its effectiveness", she said.