AIDSWEEKLY Plus; Monday, July 10, 2000
Prepared by AIDS Weekly editors from staff and other reports

NewsRx -- An international multi-site trial of the spermicide nonoxynol-9 in gel form has shown that the product is not effective in protecting women from HIV infection.

The spermicide studied is on the market in the U.S. and China under the trade name Advantage S.

"We are clearly disappointed at the results of the trial," said Dr. Peter Piot, executive director of the Joint United Nations Programme on HIV/AIDS (UNAIDS), "but the search for an effective microbicide doesn't end here. With over five million people a year becoming infected with HIV, we have to push ahead with multiple trials in order to find a product that protects against infection with the virus."

Microbicides are chemical substances - in the form of gel, cream, suppository, or film - which kill viruses and bacteria when applied vaginally or rectally before sexual intercourse.

The large-scale Phase III efficacy trial was sponsored jointly by UNAIDS and U.S.-based Columbia Laboratories, beginning in 1996. The participants were female sex workers in Benin, Cote d'Ivoire, South Africa, and Thailand.

"Prior to the start of the Phase III trial we conducted several safety studies. We found that this formulation of nonoxynol-9 did not have any of the side effects associated with other formulations of the product, such as genital sores and irritation," said Dr. Joseph Perriens, who heads the UNAIDS microbicide effort. "This paved the way for the Phase III trial. Now, we will have to continue our search for an effective product using other compounds."

At least 36 other compounds are now at the pre-clinical testing stage, while 20 are ready for early safety trials in human volunteers and three additional compounds are being considered for large-scale trials. Meanwhile, the preliminary results raise questions about the continuation of the two other nonoxynol-9 trials that are currently taking place.

Finding an effective microbicide would be a major breakthrough in preventing the spread of HIV, especially for women. "A microbicide can allow women to protect themselves and their partners from infection without necessarily having to secure male cooperation," said Dr. Awa Coll-Seck, director of UNAIDS Policy, Strategy, and Research.

One positive outcome of the trial is that fewer of the sex workers who participated became infected with HIV, compared with sex workers who did not participate at all in the study. Apart from receiving the trial microbicide or a placebo, sex workers in the study received classical HIV prevention support - free condoms, free treatment for sexually transmitted infections, counselling, and peer support.

Details of the final outcome of the trial were scheduled to be discussed during the XIII International AIDS Conference in Durban, South Africa, on July 12, 2000.

This article was prepared by AIDS Weekly editors from staff and other reports.

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