Safety of Acidform Lubricant in HIV-Uninfected Women

Summary

Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease pathogens. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to compare the safety of daily applications of Acidform lubricant and HEC gel in healthy women at low risk for HIV infection and assess the effect of a microbicide candidate on the natural immunity women have to STI pathogens.

Timeline

Start

2009-02

Primary completion

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Completion

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Publications

• Background Anderson DJ, Williams DL, Ballagh SA, Barnhart K, Creinin MD, Newman DR, Bowman FP, Politch JA, Duerr AC, Jamieson DJ. Safety analysis of the diaphragm in combination with lubricant or acidifying microbicide gels: effects on markers of inflammation and innate immunity in cervicovaginal fluid. Am J Reprod Immunol. 2009 Feb;61(2):121-9. doi: 10.1111/j.1600-0897.2008.00670.x.
• Background Behets FM, Turner AN, Van Damme K, Rabenja NL, Ravelomanana N, Swezey TA, Bell AJ, Newman DR, Williams DL, Jamieson DJ; Mad STI Prevention Group. Vaginal microbicide and diaphragm use for sexually transmitted infection prevention: a randomized acceptability and feasibility study among high-risk women in Madagascar. Sex Transm Dis. 2008 Sep;35(9):818-26. doi: 10.1097/OLQ.0b013e318175d8ab.
• Background Williams DL, Newman DR, Ballagh SA, Creinin MD, Barnhart K, Weiner DH, Bell AJ, Jamieson DJ. Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm. Sex Transm Dis. 2007 Dec;34(12):977-84. doi: 10.1097/olq.0b013e31813347e9.
• Keller MJ, Carpenter CA, Lo Y, Einstein MH, Liu C, Fredricks DN, Herold BC. Phase I randomized safety study of twice daily dosing of acidform vaginal gel: candidate antimicrobial contraceptive. PLoS One. 2012;7(10):e46901. doi: 10.1371/journal.pone.0046901. Epub 2012 Oct 8.

Drugs

Indications