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  1. 1

    WHO / CONRAD Technical Consultation on Nonoxynol-9, World Health Organization, Geneva, 9–10 October 2001. Summary report.

    World Health Organization [WHO]; Eastern Virginia Medical School. Contraceptive Research and Development Program [CONRAD]

    Geneva, Switzerland, WHO, 2003. [27] p. (PN-ACQ-110)

    An effective, easy to use vaginal microbicide would provide women with a method under their own control with which to protect themselves against infection with the human immunodeficiency virus (HIV). While many novel compounds are currently being developed and tested, it will be many years before a new product can be fully evaluated and distributed to users. The spermicide Nonoxynol-9 (N-9) has been widely available as a contraceptive for many years and has been shown to be effective against HIV in laboratory studies. If it also provided effective protection against HIV in clinical studies, N-9 could be made rapidly available to women who require protection. The World Health Organization Global Programme on AIDS (GPA) and the Joint United Nations Program on HIV/AIDS (UNAIDS) sponsored a clinical trial of a gel containing N-9 to assess its effectiveness in protecting against HIV. Preliminary results from the study were presented in July 2000 at the 13th International AIDS Conference in Durban, South Africa, and showed, contrary to expectation, that the HIV incidence was higher in women using N-9 than in women using a comparison product. While a disappointment with regard to the rapid deployment of an effective microbicide, these results also raised questions about the safety of N-9 when used for its main indication, protection against unwanted pregnancy. After presentation of the preliminary results from the study in July 2000, the World Health Organization (WHO) was approached to provide an assessment of the scientific information regarding the safety and effectiveness of N-9 when used for family planning purposes. This summary should permit Member States to assess the risks and benefits of N-9 use among women in their country who may be at risk of HIV infection from inadequately protected sexual activity. Accordingly, the WHO Department of Reproductive Health and Research (RHR) convened a Technical Consultation in October 2001, in partnership with the CONRAD Program, Arlington, VA, USA, to review the available evidence and provide advice to member states on the use of N-9. The Consultation included experts from developed and developing countries with experience in product development, safety assessment, and public health and representatives from collaborating agencies (Annex). Reviews of key issues were commissioned prior to the meeting and are summarised in this report. The meeting also considered the submitted manuscripts from recently completed studies directly relevant to the safety and effectiveness of N-9. This report summarises the evidence presented to the meeting on the safety of N-9 and its effectiveness for protection against pregnancy, sexually transmitted infections (STIs) and HIV. The meeting concluded with recommendations on the use of N-9 and identified key areas of uncertainty where more research was urgently required. (excerpt)
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  2. 2

    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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