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

• Published in: Contraception (Stoneham) Vol. 82; no. 6; pp. 563 - 571
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01-12-2010; Elsevier
• Subjects: Acceptability; Administration, Intravaginal; Adolescent; Adult; Anti-Infective Agents - administration & dosage; Anti-Infective Agents - adverse effects; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; Carrageenan - administration & dosage; Carrageenan - adverse effects; Carraguard; Coitus; Female; HIV prevention; Humans; Medical sciences; Microbicide; Middle Aged; Obstetrics and Gynecology; Pharmacology. Drug treatments; Safety; Sexually Transmitted Diseases - prevention & control; South Africa; Vaginal Creams, Foams, and Jellies - administration & dosage; Vaginal Creams, Foams, and Jellies - adverse effects; Young Adult; South Africa; Africa; Microbicide; Carraguard; South Africa; HIV prevention; Safety; Acceptability; Human; Immunopathology; Intravaginal administration; Toxicity; Retroviridae; AIDS; Immune deficiency; Lentivirus; Antimicrobial agent; Infection; Virus; Prevention; Viral disease; Phase II trial; Female; Human immunodeficiency virus; Woman
• ISSN: 0010-7824; 1879-0518
• DOI: 10.1016/j.contraception.2010.04.019

Abstract 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.