Expanded Safety And Acceptability Of The Candidate Vaginal Microbicide Carraguard (R) In South Africa

Background Carraguard s safety and acceptability was assessed among women in Gugulethu and Ga-Rankuwa South AfricaStudy 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 quarterlyResults 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 muchConclusions 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