Lancet, DOI: 10.1016/s0140-6736(02)11079-8.
The Lancet, Volume 360, Issue 9338, Pages 971 – 977, 28 September 2002
Copyright © 2002 Elsevier Ltd All rights reserved.
Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial.
Dr Lut Van Damme MD (firstname.lastname@example.org), Gita Ramjee PhD:b, Michel Alary MD:c&d, Bea Vuylsteke MD:a&e, Verapol Chandeying MD:f, Helen Rees MD:g, Pachara Sirivongrangson MD:h, Léonard Mukenge Tshibaka MD:c&i, Virginie Ettiègne-Traoré MD:e, Charn Uaheowitchai MD:j, Salim S Abdool Karim MD:b, Benoît Mâsse PhD:c&k, Jos Perriëns MD:l, Marie Laga MD:a, on behalf of the COL-1492 study group. Study group members listed at end of report.
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.
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’lvoire, 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 gonorrhoeas and Chlamydia trachomatis infections. Analysis was by intention to treat.
765 women were included in the primary analysis. HIV-1 frequency in nonoxynol-9 users was 59 (16%) of 376 compared with 104 (27%) of 389 in placebo users (402·5 vs 435·0 woman-years; hazard ratio adjusted for centre 1·5; 95% Cl 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% Cl 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 gonorrhoeas (1·2; 0·9—1·6) or C trachomatis (1·2; 0·8—1·6) infections was reported.
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.
LIST OF STUDY GROUP MEMBERS:
a: Institute of Tropical Medicine, Antwerp, Belgium
b: Medical Research Council, Durban, South Africa
c: Groupe de Recherche en Epidémiologie, Centre Hospitalier Affilié Universitaire de Québec et Université Laval, Québec, Québec, Canada
d: Projet SIDA 2, Cotonou, Bénin
e: Projet RETRO-CI, Abidjan, Côte d’lvoire
f: Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand
g: Reproductive Health Research Unit, Department of Obstetrics and Gynaecology, University of the Witwatersrand, Johannesburg, South Africa
h: Ministry of Health, Venereal Disease Division, Bangkok, Thailand
i: Dispensaire Maladies Sexuellement Transmissibles, Centre de Santé de la Circonscription Urbaine de Cotonou 1, Cotonou, Benin
j: Venereal Disease Center Region 12, Songkla, Thailand
k: Fred Hutchinson Cancer Research Center, Seattle, WA, USA
l: UNAIDS, Geneva, Switzerland
Correspondence to: Dr Lut Van Damme, CONRAD, 1611 North Kent Street, Suite 806, Arlington, VA 22209, USA
Article published online at http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(02)11079-8/abstract#cor1 and appeared there on June 22, 2014.
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