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Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial

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Show simple item record Van Damme, L. en_US Ramjee, G. en_US Alary, M. en_US Vuylsteke, B. en_US Chandeying, V. en_US Rees, H. en_US Sirivongrangson, P. en_US Mukenge-Tshibaka, L. en_US Ettiègne-Traoré, V. en_US Uaheowitchai, C. en_US Abdool Karim, S. S. en_US Mâsse, B. en_US Perriëns, J. en_US Laga, M. en_US 2007-12-06T14:48:27Z 2007-12-06T14:48:27Z 2002 en_US
dc.identifier.issn 0140-6736 en_US
dc.identifier.other ITG-M1A en_US
dc.identifier.other ITG-M4A en_US
dc.identifier.other ITG-MLA en_US
dc.identifier.other MICRO en_US
dc.identifier.other U-HIVSTD en_US
dc.identifier.other JIF en_US
dc.identifier.other DOI en_US
dc.identifier.other ABSTRACT en_US
dc.description.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. en_US
dc.language English en_US
dc.publisher Elsevier
dc.subject Viral diseases en_US
dc.subject HIV-1 en_US
dc.subject AIDS en_US
dc.subject Transmission en_US
dc.subject Prostitutes en_US
dc.subject Microbicides en_US
dc.subject Vaginal gel en_US
dc.subject Nonoxynol en_US
dc.subject Effectiveness en_US
dc.subject Clinical trials en_US
dc.title Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial en_US
dc.type Article en_US
dc.citation.issue 9338 en_US
dc.citation.jtitle Lancet en_US
dc.citation.volume 360 en_US
dc.citation.pages 971-977 en_US Amsterdam
dc.contributor.corpauthor COL-1492 study group en_US
dc.citation.jabbreviation Lancet en_US

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