Safety and toxicity of nonoxynol-9 gel as a rectal microbicide.

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.

journal_name

Sex Transm Dis

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

doi

10.1097/00007435-199911000-00005

subject

Has Abstract

pub_date

1999-11-01 00:00:00

pages

564-71

issue

10

eissn

0148-5717

issn

1537-4521

journal_volume

26

pub_type

临床试验,杂志文章
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    pub_type: 杂志文章

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    authors: Wei C,Guadamuz TE,Lim SH,Koe S

    更新日期:2012-04-01 00:00:00

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    pub_type: 临床试验,杂志文章,随机对照试验

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    pub_type: 杂志文章

    doi:10.1097/00007435-199902000-00003

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    更新日期:1999-02-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1097/00007435-200007000-00008

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    更新日期:2000-07-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1097/OLQ.0000000000001257

    authors: Ho YA,Rahurkar S,Tao G,Patel CG,Arno JN,Wang J,Broyles AA,Dixon BE

    更新日期:2020-07-31 00:00:00

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    pub_type: 杂志文章

    doi:10.1097/01.olq.0000194578.06795.2d

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    更新日期:2006-05-01 00:00:00

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    pub_type: 杂志文章

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    pub_type: 杂志文章

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    更新日期:1997-07-01 00:00:00

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    pub_type: 杂志文章

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    journal_title:Sexually transmitted diseases

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/OLQ.0b013e31824790d7

    authors: Balkus JE,Jaoko W,Mandaliya K,Richardson BA,Masese L,Gitau R,Kiarie J,Marrazzo J,Farquhar C,McClelland RS

    更新日期:2012-05-01 00:00:00

  • Predictors of bacterial vaginosis in adolescent women who douche.

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    journal_title:Sexually transmitted diseases

    pub_type: 临床试验,杂志文章,随机对照试验

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    journal_title:Sexually transmitted diseases

    pub_type: 杂志文章

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  • A prospective study of contraceptive use among African women in HIV-1 serodiscordant partnerships.

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    journal_title:Sexually transmitted diseases

    pub_type: 杂志文章

    doi:10.1097/OLQ.0b013e3181e1a162

    authors: Heffron R,Were E,Celum C,Mugo N,Ngure K,Kiarie J,Baeten JM,Partners in Prevention HSV\/HIV Transmission Study Team.

    更新日期:2010-10-01 00:00:00

  • Opt-out screening for Chlamydia trachomatis and Neisseria gonorrhoeae in female detainees at Cook County jail in Chicago, IL.

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    pub_type: 杂志文章

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    pub_type: 杂志文章

    doi:10.1097/00007435-200307000-00002

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    journal_title:Sexually transmitted diseases

    pub_type: 杂志文章

    doi:10.1097/00007435-198607000-00014

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    更新日期:1986-07-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1097/00007435-197707000-00005

    authors: Fiumara NJ

    更新日期:1977-07-01 00:00:00

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    journal_title:Sexually transmitted diseases

    pub_type: 杂志文章

    doi:10.1097/00007435-199601000-00008

    authors: Oxman GL,Smolkowski K,Noell J

    更新日期:1996-01-01 00:00:00

  • Laboratory diagnosis of gonorrhea by a simple transformation test with a temperature-sensitive mutant of Neisseria gonorrhoeae.

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    pub_type: 杂志文章

    doi:10.1097/00007435-198010000-00008

    authors: Zubrzycki L,Weinberger SS

    更新日期:1980-10-01 00:00:00

  • Chlamydia prevalence among college students: reproductive and public health implications.

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    pub_type: 杂志文章

    doi:10.1097/OLQ.0b013e3181676697

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    更新日期:2008-06-01 00:00:00

  • Evidence-based planning of a randomized controlled trial on diaphragm use for prevention of sexually transmitted infections.

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    pub_type: 杂志文章

    doi:10.1097/OLQ.0b013e31815abaa2

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    更新日期:2008-03-01 00:00:00

  • Characterization of an emerging heterosexual HIV epidemic in Russia.

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    pub_type: 杂志文章

    doi:10.1097/OLQ.0b013e3181728a9e

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    更新日期:2008-09-01 00:00:00

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    pub_type: 杂志文章

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    pub_type: 杂志文章,多中心研究

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    authors: Ng LK,Sawatzky P,Martin IE,Booth S

    更新日期:2002-12-01 00:00:00

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    pub_type: 杂志文章,评审

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    更新日期:2012-03-01 00:00:00