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, 0.64; 95% confidence interval, 0.37-1.10); 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.
RCT Entities:
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, 0.64; 95% confidence interval, 0.37-1.10); 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.
Authors: C Coggins; K Blanchard; F Alvarez; V Brache; E Weisberg; P H Kilmarx; M Lacarra; R Massai; D Mishell; A Salvatierra; P Witwatwongwana; C Elias; C Ellertson Journal: Sex Transm Infect Date: 2000-12 Impact factor: 3.519
Authors: I Mary Poynten; Iona Y Millwood; Michael O Falster; Matthew G Law; David N Andresen; Lut Van Damme; John M Kaldor Journal: AIDS Date: 2009-06-19 Impact factor: 4.177
Authors: Kathleen M Morrow; Joseph L Fava; Rochelle K Rosen; Sara Vargas; Julia G Shaw; E Milu Kojic; Patrick F Kiser; David R Friend; David F Katz Journal: AIDS Res Hum Retroviruses Date: 2013-12-09 Impact factor: 2.205
Authors: Tao Zhang; Chi Zhang; Vivek Agrahari; James B Murowchick; Nathan A Oyler; Bi-Botti C Youan Journal: Antiviral Res Date: 2012-12-26 Impact factor: 5.970
Authors: Akiva P Novetsky; Marla J Keller; Ana Gradissimo; Zigui Chen; Stephanie L Morgan; Xiaonan Xue; Howard D Strickler; José A Fernández-Romero; Robert Burk; Mark H Einstein Journal: Gynecol Oncol Date: 2016-09-10 Impact factor: 5.482
Authors: Ann E Jerse; Hong Wu; Mathanraj Packiam; Rachel A Vonck; Afrin A Begum; Lotisha E Garvin Journal: Front Microbiol Date: 2011-07-01 Impact factor: 5.640
Authors: Barbara A Friedland; Marie Stoner; Michelle M Chau; Marlena Gehret Plagianos; Sumen Govender; Neetha Morar; Lydia Altini; Stephanie Skoler-Karpoff; Khatija Ahmed; Gita Ramjee; Constance Monedi; Robin Maguire; Pekka Lähteenmäki Journal: AIDS Behav Date: 2016-11
Authors: Keith Levendosky; Olga Mizenina; Elena Martinelli; Ninochka Jean-Pierre; Larisa Kizima; Aixa Rodriguez; Kyle Kleinbeck; Thierry Bonnaire; Melissa Robbiani; Thomas M Zydowsky; Barry R O'Keefe; José A Fernández-Romero Journal: Antimicrob Agents Chemother Date: 2015-09-14 Impact factor: 5.191