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Nonoxynol-9 Couples Study |
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Safety and toxicity of nonoxynol-9 gel as a rectal microbicide.
Source:
Sex Transm Dis 1999 Nov;26(10):564-71
Authors:
Tabet SR, Surawicz C, Horton S, Paradise M, Coletti AS, Gross M, Fleming TR, Buchbinder
S, Haggitt RC, Levine H, Kelly CW, Celum CL.
Publication Info:
University of Washington, Seattle, USA.
Abstract:
BACKGROUND AND OBJECTIVES: Methods of HIV and STD prevention, which can be controlled by
the receptive partner, are a high priority for research and development. Studies on the
safety of Nonoxynol-9 (N-9) on the vaginal mucosa have yielded conflicting results. No
Phase I study has evaluated the effect of N-9 on the rectal mucosa. GOALS: To assess the
safety of 52.5 mg of N-9 in a 1.5-g gel when applied one to four applicators per day to
the rectum and penis. STUDY DESIGN: The study included 25 HIV-negative and 10
HIV-positive, monogamous gay male couples in which each partner was exclusively
insertive or receptive while using N-9 gel. Each participant served as his own control
during placebo gel use compared to during N-9 gel use. Receptive partners underwent
anoscopic examination after 1 week of placebo use and after 2, 5, and 6 weeks of N-9 gel
use, with rectal biopsies obtained after 1 week of placebo use and after 5 and 6 weeks
of N-9 gel use. Insertive partners had safety monitoring after 1 week of placebo use and
after 2, 5, and 6 weeks of N-9. RESULTS: No rectal ulcers were detected; superficial
rectal erosions were noted in two HIV-negative participants. Abnormal or slightly
abnormal histologic abnormalities of rectal biopsies were detected in 31 (89%) receptive
participants after N-9 gel use compared to 24 (69%) participants after 1 week of placebo
gel use. Meatal ulceration, not caused by herpes simplex virus, was detected in one
HIV-negative participant. CONCLUSION: Low-dose N-9 gel was not associated with
macroscopic rectal and penile epithelial disruption or inflammation, but histologic
abnormalities were commonly observed during N-9 gel as well as during placebo gel use.
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