Safety of multiple daily applications of COL-1492, a nonoxynol-9 vaginal gel, among female sex workers

被引:70
作者
Van Damme, L
Chandeying, V
Ramjee, G
Rees, H
Sirivongrangson, P
Laga, M
Perriëns, J
机构
[1] Inst Trop Med, STD HIV Res & Intervent Unit, B-2000 Antwerp, Belgium
[2] Prince Songkla Univ, Hat Yai, Thailand
[3] Ctr Epidemiol Res, Durban, South Africa
[4] Reprod Hlth Res Unit, Johannesburg, South Africa
[5] Minist Publ Hlth, VD Div, Bangkok, Thailand
[6] UNAIDS, Geneva, Switzerland
关键词
microbicides; effectiveness; colposcopy; clinical trial; female sex workers; safety; HIV prevention; female controlled methods;
D O I
10.1097/00002030-200001070-00010
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Rationale: COL-1492 is a nonoxynol-9 (N-9)-containing vaginal gel and may be a potential microbicide. As part of an effectiveness:trial, an initial toxicity study was conducted. Objectives: The main objective of the reported study was the assessment of the toxicity of a 52.5 mg N-9 gel, COL-1492, when used a number of times each day by female sex workers. Methods: This was a randomized, placebo-controlled triple-blinded trial among female sex workers. The participants were asked to use the product for each vaginal sexual act. At each monthly visit a gynaecological examination with sexually transmitted disease sampling and colposcopy was performed. Venous blood was drawn for syphilis and HIV serology. All women received intensive counselling on condom use. Male condoms and sexually transmitted disease treatment were given free of charge. Results: Only blinded results on the colposcopic examinations are reported. The incidence of lesions with or without an epithelial disruption was low: 0.06 and 0.29, respectively, per 100 woman-days in group A; 0.09:and 0.26 respectively per 100 woman-days in group B. There was no significant difference between the two arms. Conclusion: The multiple daily use of COL-1492 by female sex workers did not show an increase of local toxicity over that of a placebo. Colposcopy was discontinued in the autumn of 1997 in accordance with a Data Safety Monitoring Board decision. In the currently ongoing effectiveness trial the,assessment of the product's toxicity continues to be monitored by simple visual examination. (C) 2000 Lippincott Williams & Wilkins.
引用
收藏
页码:85 / 88
页数:4
相关论文
共 21 条
  • [1] INHIBITION OF GROWTH OF CHLAMYDIA-TRACHOMATIS BY NONOXYNOL-9 INVITRO
    BENES, S
    MCCORMACK, WM
    [J]. ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 1985, 27 (05) : 724 - 726
  • [2] The efficacy of nonoxynol-9 from an in vitro point of view
    Bourinbaiar, AS
    Fruhstorfer, EC
    [J]. AIDS, 1996, 10 (05) : 558 - 559
  • [3] Do spermicides containing nonoxynol-9 prevent sexually transmitted infections?: A meta-analysis
    Cook, RL
    Rosenberg, MJ
    [J]. SEXUALLY TRANSMITTED DISEASES, 1998, 25 (03) : 144 - 150
  • [4] FREQUENT USE OF MENFEGOL SPERMICIDAL VAGINAL FOAMING TABLETS ASSOCIATED WITH A HIGH-INCIDENCE OF GENITAL LESIONS
    GOEMAN, J
    NDOYE, I
    SAKHO, LM
    MBOUP, S
    PIOT, P
    KARAM, M
    BELSEY, E
    LANGE, JMA
    LAGA, M
    PERRIENS, JH
    [J]. JOURNAL OF INFECTIOUS DISEASES, 1995, 171 (06) : 1611 - 1614
  • [5] The effect of nonoxynol-9 and chlorhexidine on HIV and sperm in vitro
    Harrison, C
    Chantler, E
    [J]. INTERNATIONAL JOURNAL OF STD & AIDS, 1998, 9 (02) : 92 - 97
  • [6] HICKS DR, 1985, LANCET, V2, P1422
  • [7] Condom and nonoxynol-9 use and the incidence of HIV infection in serodiscordant couples in Zambia
    Hira, SK
    Feldblum, PJ
    Kamanga, J
    Mukelabai, G
    Weir, SS
    Thomas, JC
    [J]. INTERNATIONAL JOURNAL OF STD & AIDS, 1997, 8 (04) : 243 - 250
  • [8] EFFICACY OF NONOXYNOL-9 CONTRACEPTIVE SPONGE USE IN PREVENTING HETEROSEXUAL ACQUISITION OF HIV IN NAIROBI PROSTITUTES
    KREISS, J
    NGUGI, E
    HOLMES, K
    NDINYAACHOLA, J
    WAIYAKI, P
    ROBERTS, PL
    RUMINJO, I
    SAJABI, R
    KIMATA, J
    FLEMING, TR
    ANZALA, A
    HOLTON, D
    PLUMMER, F
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1992, 268 (04): : 477 - 482
  • [9] LAGA M, 1991, AIDS, V5, pS55
  • [10] A CLINICAL-TRIAL OF NONOXYNOL-9 FOR PREVENTING GONOCOCCAL AND CHLAMYDIAL INFECTIONS
    LOUV, WC
    AUSTIN, H
    ALEXANDER, WJ
    STAGNO, S
    CHEEKS, J
    [J]. JOURNAL OF INFECTIOUS DISEASES, 1988, 158 (03) : 518 - 523