A CONTROLLED TRIAL OF NONOXYNOL-9 FILM TO REDUCE MALE-TO-FEMALE TRANSMISSION OF SEXUALLY-TRANSMITTED DISEASES

Background Nonoxynol 9 is a proved spermicide, but whether it is also a microbicide is uncertain. A truly effective vaginal microbicide woul d reduce the susceptibility of women to sexually transmitted diseases, including infection with the human immunodeficiency virus (HIV). Meth ods We enrolled 1292 HIV-negative female sex workers in Cameroon in a double-blind, placebo-controlled study in which the participants were randomly assigned to use either a film containing 70 mg of nonoxynol 9 or a placebo film, inserted into the vagina before intercourse. All o f the women were provided with latex condoms and were instructed to ha ve their male sexual partners use them. At monthly follow-up visits, w e examined the women with a colposcope for genital lesions, tested end ocervical specimens for gonorrhea and chlamydia infection with DNA pro bes, tested for HIV infection, and treated the women for curable sexua lly transmitted diseases. Results The rates of HIV infection (cases pe r 100 woman-years) were 6.7 in the nonoxynol 9 group and 6.6 in the pl acebo group (rate ratio, 1.0; 95 per cent confidence interval, 0.7 to 1.5). The rates of genital lesions were 42.2 cases per 100 woman-years in the nonoxynol 9 group and 33.5 in the placebo group (rate ratio, 1 .3; 95 percent confidence interval, 1.0 to 1.6). The rates of gonorrhe a were 33.3 and 31.1 cases per 100 woman-years in the nonoxynol 9 and placebo groups, respectively (rate ratio, 1.1; 95 percent confidence i nterval, 0.8 to 1.4). The corresponding rates of chlamydia infection i n the nonoxynol 9 group and the placebo group were 20.6 and 22.2 cases per 100 woman-years (rate ratio, 0.9; 95 percent confidence interval, 0.7 to 1.3). The women reported that condoms were used during 90 perc ent of sexual acts. Conclusions The use of a nonoxynol 9 vaginal film did not reduce the rate of new HIV, gonorrhea, or chlamydia infection in this group of sex workers who used condoms and received treatment f or sexually transmitted diseases. (N Engl J Med 1998;339: 504-10.) (C) 1998, Massachusetts Medical Society.