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New hope for HIV gel

3rd March 2008

A new microbicide gel containing an anti-HIV drug has been pronounced safe for daily use by women, a conference on microbicides has heard.

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The findings of the study were presented at a conference in the Indian capital dedicated to researching the use of microbicides, gels, pastes or films to prevent the transmission of HIV through heterosexual intercourse.

Delegates to Microbicides 2008 in Delhi heard that the gel, which contains the antiretroviral drug tenofovir, was cleared for further clinical trials in humans.

Tenofovir targets HIV by blocking the action of a key enzyme needed for the virus to replicate.

Phase II trials of the gel in India and the United States in 2007 compared the gel with a placebo in 200 sexually active, uninfected women.

The study, sponsored by the US National Institutes of Health and conducted by the Microbicides Trials Network (MTN) found no effects liver, blood or kidney function — both when it was used daily for a period of six months and before each act of sex.

MTN lead investigator Sharon Hillier told the conference the trials had found high levels of compliance, around 80%, among the women participating.

The search is on to find a microbicide which can limit the spread of HIV, because aversion to condom use and lack of economic empowerment among women in traditional cultures leaves women vulnerable to infection by male partners.

A gel, film or sponge which is controlled by the woman and effectively blocks HIV transmission has yet to be developed, however.

More than 90% of the women participating said they would use such a gel if it were found to be effective against HIV.

A series of trials in Africa and the United States over the next two years will study if the drug is absorbed into the foetus during pregnancy, dose absorption in women and whether the drug is more effective as an oral pill or vaginal gel.

Hillier, who also directs the Department of Obstetrics, Gynaecology and Reproductive Sciences at the University of Pittsburgh, said the oral route versus topical application of an anti-HIV drug was the key scientific question researchers wanted answered.

Between 70% and 90% of HIV infections in women occur through heterosexual intercourse. The cells in the lining of the female genital tract rupture more easily that those in men, making it easier for the virus to enter.

Microbicide research has suffered a series of setbacks in recent years, including the early closure of trials for cellulose sulphate microbicide, and the announcement this month that a microbicide gel based on a seaweed extract, Carraguard, fails to prevent HIV transmission.

 

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