Van Damme L, Ramjee G, Alary M, et al. Lancet. 2002;360:962–964
Purpose of the Study.
Nonoxynol-9, marketed as a spermicidal contraceptive, has in vitro anti-human immunodeficiency virus (HIV) activity. This study was designed to assess the effectiveness of COL-1492, a nonoxynol-9 vaginal gel, in the prevention of HIV infection in women with a high risk of HIV exposure.
This was a randomized, placebo-controlled, fully masked phase II/III trial with COL-1492. Eight hundred ninety-two female sex workers in 4 developing countries were assigned to receive the nonoxynol-9 gel (449 women) or a placebo gel (443 women). The primary endpoint was incident HIV infection; secondary endpoints included Neisseria gonorrhoeae and Chlamydia trachomatis infections.
Thirty-two percent of the women reported using >3 applicators per working day. In these women, the risk of HIV infection in nonoxynol-9 users was almost twice that in placebo users. In the 68% of women who used the applicators less frequently, there was no difference in HIV infection incidence. There were no significant effects on nonoxynol-9 on N gonorrhoeae or C trachomatis infections.
COL-1492, a nonoxynol-9 containing vaginal gel does not protect high-risk women from HIV infection. Further, multiple applications of nonoxynol-9 appear to enhance the risk of HIV infection likely by causing local toxic effects on the vaginal mucosa.
This report is consistent with other trials that demonstrated that nonoxynol-9 was not effective in preventing sexually transmitted diseases including HIV and that it might actually increase the risk for HIV transmission. Because of these findings, the World Health Organization has concluded that nonoxynol-9 should not be used or promoted for the prevention of HIV or sexually acquired infections. For sexually active adolescents, only abstinence and condoms should be recommended for the prevention of HIV or other sexually acquired infections.