Sign In / Register
Make This My Home Page | Feedback |RSS
You are here: IE »   Story

India trials of anti-HIV gel halted over risk to women

  • Print
  • Mail This Article
  • Comments
  • Add to favorites
  • Trials of a microbicidal gel to prevent HIV infection during sex have been halted in India and Africa after an independent scientific committee found that the active ingredient, cellulose sulphate, increased the risk of women contracting the virus.

    Some scientists consider this a setback because microbicidal gels, creams or suppositories are seen as a cheap way to prevent the spread of AIDS in poor countries, especially in women whose partners refuse to use condoms.

    Cellulose sulphate was developed as an anti-HIV microbicide by Polydex Pharmaceuticals of Toronto and its trials were being conducted across the world by Conrad, a health-research group based in Virginia.

    According to Conrad, the independent committee had found, in a small study of its own, that more women using cellulose sulphate developed HIV than those using a placebo, or inactive gel.

    Ads by Google

    In India, the Conrad trials were being implemented by YRG Care, Chennai, and St John’s Medical College, Bangalore.

    “We were told to stop the trial on January 27,” said Dr Reynold Washington, a professor at St John’s who is the principal investigator for the trial in Bagalkot district of Karnataka. “Yes, it’s a great setback as microbicides are being perceived as a new tool to prevent HIV.”

    Dr Washington said it took a long time to find and enrol participants and counsel them.

    “We had enrolled 20-25 women who were HIV negative and the trial had only begun as the government had given clearance only last year,” he said. “We have not had any sero-conversions, which means those who are HIV negative have not turned positive.”

    However, he said his team had learnt valuable lessons in setting up trials, managing data, building confidence among participants, and adhering to good clinical practices.

    For Dr Suniti Solomon, Director of YRG Care, Chennai, too the halt is a “huge disappointment.” YRG Care had enrolled 250 women, including sex workers who were not HIV positive.

    “They (Conrad) had found problems at a site in Africa last year itself and had immediately told us to stop the trial here, in October last year,” Solomon said.

    Like in the Bagalkot study, none of the participants in Chennai had contracted the HIV virus, said Solomon.

    Scientists are particularly surprised at the calling-off of the trial for cellulose sulphate, because it had already reached Phase-III, after clearing multiple safety trials. In 2000, another microbicide on trial, nonoxynol-9, had been declared unsafe.

    Trials continue, however, on two other microbicides, Pro 2000 of Indevus Pharma, and BufferGel of ReProtect and Carreguard, whose trademark is held by the Population Council.

    Comments
    Post comment

    Be the first to comment.

    Post a Comment
    Name:
    Email:
    Title:
    Maximum characters allowed     
    Comment:
    TERMS OF USE:
    The views, opinions and comments posted are your, and are not endorsed by this website. You shall be solely responsible for the comment posted here. The website reserves the right to delete, reject, or otherwise remove any views, opinions and comments posted or part thereof. You shall ensure that the comment is not inflammatory, abusive, derogatory, defamatory &/or obscene, or contain pornographic matter and/or does not constitute hate mail, or violate privacy of any person (s) or breach confidentiality or otherwise is illegal, immoral or contrary to public policy. Nor should it contain anything infringing copyright &/or intellectual property rights of any person(s).
    I agree to the terms of use.