ABSTRACT
van de Wijgert, Janneke, Andrew Fullem, Clifton Kelly, Sajay Mehendale, Sungwal Rugpao, Newton Kumwenda, Zvavahera Chirenje, Mita Joshi, Taha Taha, Nancy Padian, Robert Bollinger, and Kenrad Nelson. 2001. "Phase 1 trial of the topical microbicide BufferGel: Safety results from four international sites," Journal of Acquired Immune Deficiency Syndromes 26(1): 21–27.
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 percent. Epithelial abnormalities detected by pelvic examination or colposcopy were uncommon (eight 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 percent at enrollment to 6 percent at one week, and 7 percent at two weeks of BufferGel use. Thirty-two women acquired microscopically detectable yeast during BufferGel exposure, but only three 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.
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