Expanded safety and acceptability of the candidate vaginal microbicide Carraguard® in South Africa

被引：20

作者：

Altini, Lydia ^{[2
]}

Blanchard, Kelly ^{[1
]}

Coetzee, Nicol ^{[2
]}

de Kock, Alana ^{[2
]}

Elias, Christopher ^{[1
]}

Ellertson, Charlotte ^{[1
]}

Friedland, Barbara ^{[1
]}

Hoosen, Anwar ^{[3
]}

Jones, Heidi E. ^{[1
]}

Kilmarx, Peter H. ^{[4
]}

Marumo, Mabitso ^{[3
]}

McGrory, Elizabeth ^{[1
]}

Monedi, Constance ^{[3
]}

Ndlovu, Gugulethu ^{[1
]}

Nkompala, Bels ^{[2
]}

Pistorius, Annalie ^{[3
]}

Ramjee, Gita ^{[5
]}

Sebola, Mohlatlego ^{[3
]}

Sorhaindo, Annik ^{[1
]}

Turner, Abigail Norris ^{[1
]}

Tweedy, Kathryn ^{[6
]}

van de Wijgert, Janneke ^{[1
]}

Williams, Manuela M. ^{[3
]}

Winikoff, Beverly ^{[1
]}

机构：

[1] Populat Council, New York, NY 10017 USA

[2] Univ Cape Town, Dept Publ Hlth, ZA-7925 Cape Town, South Africa

[3] Univ Limpopo, Dept Med Microbiol, ZA-0204 Medunsa, South Africa

[4] Ctr Dis Control & Prevent, CDC, Atlanta, GA 30333 USA

[5] Med Res Council MRC Overport, ZA-4067 Durban, South Africa

[6] Family Hlth Int, Res Triangle Pk, NC 27709 USA

来源：

CONTRACEPTION | 2010年 / 82卷 / 06期

基金：

美国国家卫生研究院;

关键词：

HIV prevention; Microbicide; Carraguard; Safety; Acceptability; South Africa; PLACEBO-CONTROLLED TRIAL; BACTERIAL VAGINOSIS; DOUBLE-BLIND; WOMEN; GEL; NONOXYNOL-9; INFECTION; PREVENTION; RISK; MICE;

D O I：

10.1016/j.contraception.2010.04.019

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

Background Carraguard s safety and acceptability was assessed among women in Gugulethu and Ga-Rankuwa South Africa Study Design A randomized, placebo controlled, triple-blind trial was conducted in HIV negative, nonpregnant women who inserted Carraguard or placebo at least three times a week, including before vaginal sex, for 6 to 12 months Monthly visits included pelvic examination, sexually transmitted infection (STI) testing/treatment and HIV counseling/testing Acceptability was assessed quarterly Results Of 400 women (205 Carraguard, 195 placebo) enrolled, 328 (77%) completed at least 6 months Incidence of genital epithelial disruption was similar between the Carraguard (13 6 per 100 woman-years) and placebo (21 3 per 100 woman years) groups (relative risk, 064, 95% confidence interval 037-1 10), there were no significant differences in rates of HIV/STI, though the study was not powered to determine effectiveness Only 2% of adverse events were judged possibly related to (either) gel More than 94% of women reported at least once liking the gel very much Conclusions Carraguard was not associated with more vaginal cervical or external genital irritation than placebo, and it was acceptable when used approximately 3 5 times per week, including during sex (C) 2010 Elsevier Inc All rights reserved

引用

页码：563 / 571

页数：9

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