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HIV cream 'safe but ineffective'

19th February 2008

Trials of a microbicide cream supposed to prevent HIV transmission have showed that the product is safe, but ineffective.

hiv

Tests on the cream, Carraguard, were carried out over three years in 6,000 South African women, finishing in March 2007.

But results showed no difference in HIV infections between the group using Carraguard and the control group, which used a placebo.

Principal investigator Khatija Ahmed said the trial was unable to demonstrate Carraguard's efficacy in preventing HIV transmission.

The product contains carrageenan, a thickening agent derived from seaweed, and was developed by the international non-profit Population Council.

Earlier tests had suggested the cream might prevent HIV and other sexually transmitted infections, but the effects produced in the laboratory did not translate to humans, according to Ahmed.

The trials were affected by the fact that only 10% of women using Carraguard did so every time they had sex. On the other hand, trial participants began using condoms more frequently during the trial. At the beginning of the study, only 33% of women used condoms. That proportion had risen to 64% by the end of the trial.

Researchers said however that the Carraguard trial was a milestone because it had produced a cream which did not have any safety implications, which could still be useful in future attempts to develop a microbicide.

In the absence of an AIDS vaccine, specialists say development of a microbicide is needed to protect women whose partners refuse to use condoms, particularly in poorer countries.

Trials of a number of microbicides, which can be applied by women in the form of gels, films, creams and sponges, have all failed so far to produce a safe, effective candidate to prevent transmission of HIV and other sexually transmitted diseases.

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. And the US-based reproductive health research organisation, CONRAD, pulled the plug on trials of a cellulose-sulphate microbicide gel after it appeared to be boosting HIV infections rather than cutting them.

Campaigners said the Carraguard result was not a setback, however, and would yield results in other ways. For example, the women who took part had been affected by their participation.

According to Fiona Scorgie, programmes coordinator at the Gender AIDS Forum, the safety of Carraguard means that it could have potential as a basis for the development of future microbicides.

She called for more community involvement in such trials in future.


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