Effectiveness of COL-1492, a nonoxynol-9 Vaginal Gel, on HIV-1 Transmission in Female Sex Workers: A Randomised Controlled Trial

Lancet. 2002 Sep 28;360(9338):971-7. doi: 10.1016/s0140-6736(02)11079-8.

Abstract

Background: Nonoxynol-9 (rINN, nonoxinol-9) is an over-the-counter spermicide that has in-vitro anti-HIV-1 activity. Results of studies of its effectiveness in prevention of HIV-1 infection in women have been inconclusive. We aimed to assess effectiveness of this vaginal gel.

Methods: We did a randomised, placebo-controlled, triple-blinded, phase 2/3 trial with COL-1492, a nonoxynol-9 vaginal gel, in 892 female sex workers in four countries: Benin, Côte d'Ivoire, South Africa, and Thailand. 449 women were randomly allocated nonoxynol-9 and 443 placebo. Primary endpoint was incident HIV-1 infection. Secondary endpoints included Neisseria gonorrhoeae and Chlamydia trachomatis infections. Analysis was by intention to treat.

Findings: 765 women were included in the primary analysis. HIV-1 frequency in nonoxynol-9 users was 59 (16%) of 376 compared with 45 (12%) [corrected] of 389 in placebo users (402.5 vs 435.0 woman-years; hazard ratio adjusted for centre 1.5; 95% CI 1.0-2.2; p=0.047). 239 (32%) women reported use of a mean of more than 3.5 applicators per working day, and in these women, risk of HIV-1 infection in nonoxynol-9 users was almost twice that in placebo users (hazard ratio 1.8; 95% CI 1.0-3.2). 516 (68%) women used the gel less frequently than 3.5 times a day, and in these, risk did not differ between the two treatments. No significant effect of nonoxynol-9 on N gonorrhoeae (1.2; 0.9-1.6) or C trachomatis (1.2; 0.8-1.6) infections was reported.

Interpretation: This study did not show a protective effect of COL-1492 on HIV-1 transmission in high-risk women. Multiple use of nonoxynol-9 could cause toxic effects enhancing HIV-1 infection. This drug can no longer be deemed a potential HIV-1-prevention method. Assessment of other microbicides should continue.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Chlamydia trachomatis / drug effects
  • Female
  • Gels
  • HIV Infections / transmission*
  • HIV-1
  • Humans
  • Male
  • Neisseria gonorrhoeae / drug effects
  • Nonoxynol / administration & dosage*
  • Sex Work*
  • Spermatocidal Agents / administration & dosage*

Substances

  • Gels
  • Spermatocidal Agents
  • Nonoxynol