Phase 1 Trial of the Topical Microbicide BufferGel: Safety Results From Four International Sites

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Abstract
Aim:To evaluate the safety of BufferGel (ReProtect LLC, Baltimore, MD), a spermicidal microbicide that acidifies semen and maintains the protective acidity of the vagina, in a high-dose tolerance trial. Methods:HIV/STD negative, sexually abstinent, and sexually active women in India, Thailand, Malawi, and Zimbabwe were asked to insert one applicator (˜5 ml) of BufferGel vaginally twice per day for 14 days. Sexually active women agreed to have sex (while using BufferGel and nonlubricated condoms) at least twice per week. Results:In total, 98 women (30 sexually abstinent and 68 sexually active) were enrolled. Overall compliance with product use was 93%. Epithelial abnormalities detected by pelvic examination or colposcopy were uncommon (8 cases in 271 examinations). Irritation was reported by approximately one quarter of the women (0.58 events per woman-week) but was generally mild and of short duration. The prevalence of bacterial vaginosis (BV) fell significantly, from 30% at enrollment to 6% at one week, and 7% at two weeks of BufferGel use. Thirty-two women acquired microscopically detectable yeast during BufferGel exposure, but only 3 developed symptomatic vaginitis. Conclusion:BufferGel appears to be safe and well tolerated by the cervicovaginal epithelium. Its effect on BV and yeasts merits further study. Janneke van de Wijgert is currently affiliated with the Population Council, New York City, New York, U.S.A. Andrew Fullem is currently affiliated with the Massachusetts Department of Health, Boston, Massachusetts, U.S.A. Address correspondence and reprint requests to Janneke van de Wijgert, Population Council, International Programs Division, One Dag Hammarskjold Plaza, New York City, NY 10017 U.S.A.; e-mail: [email protected] Manuscript received August 14, 2000; accepted October 20, 2000. © 2001 Lippincott Williams & Wilkins, Inc.