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Aids gel ineffective
18/02/2008 21:43 - (SA)
Johannesburg - An anti-Aids gel that had reached the final phase of testing was unable to prevent the transmission of the HIV infection, research NGO and NPO Population Council said on Monday.
The non-governmental and non-profit organisation said the third phase of the clinical trials into the product found it ineffective in preventing male-to-female HIV transmission during vaginal intercourse.
"We are disappointed that this trial did not show Carraguard to be effective, nonetheless the completion of this trial is a milestone in HIV prevention research," said Population Council president Peter Donaldson.
He said the trial had contributed to knowledge around product development, trial design and women and their partner's willingness to use the gel consistently.
Carraguard was an odourless and tasteless clear gel made from carrageenan, a derivative of seaweed.
The trial was part of the council's research into creating vaginal microbicides to develop female-initiated methods for reducing male-to-female transmission of HIV and possibly other sexually transmitted infections.
"Women need more options to protect themselves from infection because current prevention strategies are not always feasible," said the council.
"The... study found that there were no safety-related differences between women using Carraguard and women using the placebo, and that gel-related side effects were minor and infrequent."
The Carraguard trial started in March 2004 and ended in March 2007.
A total of 6 202 women in South Africa took part at three different sites.
These were the Setshaba Research Centre, through the University of Limpopo's Medunsa campus, the Empilisweni Centre for Wellness Studies, through the University of Cape Town and the Isipingo Clinic, through the Medical Research Council of South Africa.
Researchers found that there was an incidence of 3.3 new infections per 100 woman using Carraguard.
A test group given a placebo gel had an incidence of 3.7 infection per 100 women.
The differences between the two groups were not statistically significant. Both groups were given condoms.
Previous laboratory research had shown Carraguard to be effective in blocking cells from becoming infected by HIV.
It had protected mice from some other sexually transmitted infections.
Earlier clinical trials using the product and other similar carrageenan formulations had taken place in Australia, Chile, the Dominican Republic, Finland, South Africa, Thailand, and the United States.
Participants in the study received HIV education and counselling, gynaecological exams and testing and treatment for curable sexually transmitted infections.
Women who were HIV-positive at screening or who became HIV positive during the trial were given medical and psychological assistance.
The trial was funded by US Agency for International Development and the Bill & Melinda Gates Foundation.
"The Population Council will use these trial results to accelerate the development of effective means for women to protect themselves against HIV," said Director of the council's HIV and Aids programme Naomi Rutenberg.
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