Journal Article

Safety and Tolerability of BufferGel, a Novel Vaginal Microbicide, in Women in the United States

Kenneth H. Mayer, Jeffrey Peipert, Thomas Fleming, Andrew Fullem, Thomas Moench, Susan Cu-Uvin, Margaret Bentley, Margaret Chesney and Zeda Rosenberg

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 32, issue 3, pages 476-482
Published in print February 2001 | ISSN: 1058-4838
Published online February 2001 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/318496
Safety and Tolerability of BufferGel, a Novel Vaginal Microbicide, in Women in the United States

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BufferGel (ReProtect, LLC) is a vaginal gel with an acidic buffering action that was designed to prevent vaginal neutralization by semen. The purpose of this study was to evaluate the safety and tolerability of BufferGel (ReProtect, Limited Liability Company) applied vaginally either once or twice daily by 27 women who were at low risk for acquisition of human immunodeficiency virus (HIV). Participants initially used the product once daily for 14 days and then twice daily for 14 days; they underwent colposcopy before and after product exposure. BufferGel was well tolerated, although two-thirds of the participants reported at least 1 mild or moderate adverse experience. The most common adverse events were irritative genitourinary symptoms. Product use was discontinued after 3 adverse events. BufferGel was well tolerated in women at low risk for acquisition of HIV; toxicity was limited and occurred at frequencies similar to those in women who did not use any vaginal product and at levels lower than in women who used detergent-based microbicides.

Journal Article.  4596 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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