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  1. 1

    Study of side-effects of vaginal microbicide.


    In January 1994, a clinical trial was launched in Amsterdam, Antwerp, and Bangkok to study the side effects of 2 weeks of daily use of Nonoxynol-9. A total of 300 women will be examined for scars and other damage caused by the Nonoxynol to the vaginal linings. Nonoxynol is known to kill sperm, and it was found to kill HIV in vitro in 1985. The World Health Organization (WHO) intends to develop Nonoxynol as a vaginal microbicide for women's protection against infection with HIV during vaginal penetration. The WHO has charged three university hospitals with the study of the effects to the vagina of a daily dose of 50mc to ascertain if Nonoxynol is worth developing as a microbicide. In the Netherlands, nonpregnant women aged 18-45 were solicited to participate. They were told to continue using their regular contraceptive. However, nobody mentioned the possibility that these women could be at risk of contracting HIV, as only one of them claimed to use condoms consistently. Questions remain unanswered as to the use and development of vaginal microbicides. The method is meant to increase women's autonomy in the prevention of HIV infection and empower them regarding their sexuality. It is doubtful whether the method's availability, cost, and resistance to heat and humidity have been considered. The WHO insists the vaginal microbicides are not meant to replace condoms, but it is certain at this moment that women are again targeted in the battle against the spread of AIDS.
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  2. 2
    Peer Reviewed

    Boost for vaginal microbicides against HIV.

    Lange JM; Karam M; Piot P

    Lancet. 1993 Nov 27; 342(8883):1356.

    In November 1993, WHO and the UK Department of Health cosponsored a meeting at which the participants addressed the need for women-controlled methods of preventing HIV infection. They called for animal studies to develop vaginal microbicides active against HIV which, in an ideal situation, the women could use without their sexual partners' knowledge. Ideally, any new product would also prevent transmission of other sexually transmitted diseases (STDs). They did caution, however, that the use of such microbicides should not replace, but complement other methods to prevent sexual transmission of HIV. They recommended also that appropriate clinical trials testing the safety and efficacy of the product should also take place. Participants called for WHO to develop the prototype protocols for phase I-III trials of vaginal microbicides. Some spermicides (nonionic detergents or surfactants) provide protection against some STDs (gonorrhea and chlamydial infections) and, in vitro, destroy HIV. Yet, they tend to irritate vaginal mucosa, facilitating HIV transmission. The likelihood of vaginal irritation increases with frequency of use and with doses. Women may not have symptoms indicating that they have spermicide-induced mucosal lesions. A study in Nairobi suggests that use of a sponge impregnated with high dose nonoxynol-9 increased the probability of HIV seroconversion. Lower doses of nonoxynol-9 had a protective effect against HIV seroconversion in studies in Cameroon and Zambia. In all these studies, however, there were sizable methodological limitations. The risk/benefit ratio for individuals using low to moderate doses of spermicides is not clear. Another consideration in that prevention of STDs, significant risk factors for HIV transmission, would reduce the spread of HIV.
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