Vaginal and rectal topical microbicide development: safety and efficacy of 1.0% Savvy (C31G) in the pigtailed macaque.

Sexually Transmitted Diseases
D L PattonS L Hillier

Abstract

A 1.0% gel formulation of C31G, a surfactant, has been shown to have in vitro antiviral and antibacterial activity. The goal of this study was to evaluate the safety and efficacy of vaginal and rectal applications of 1.0% Savvy (C31G) in the nonhuman primate model. The safety of repeated 1.0% C31G application was evaluated by microflora, pH, vaginal biopsy, colposcopy, and rectal lavage. Efficacy in preventing chlamydial infection was documented by culture, nucleic acid amplification tests, and serology. Repeated applications of Savvy (1.0% C31G) were not associated with significant changes in pH, microflora, or inflammatory infiltrates on tissues. No significant differences in epithelial desquamation were noted after rectal product use compared with placebo. Four of 6 animals were protected from chlamydial infection after pretreatment with Savvy. C31G was shown to be safe to both vaginal and rectal mucosal tissues and to the microflora with repeated daily use. Savvy has an acceptable safety profile after repeated vaginal and rectal use. A single intravaginal application of 1.0% C31G provided partial protection from acquiring cervical chlamydial infection.

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Citations

Jun 27, 2007·AIDS and Behavior·Kathleen M Morrow, Monica S Ruiz
Nov 6, 2013·Antiviral Research·Lisa C RohanLin Wang
Mar 8, 2008·ILAR Journal·Murray B Gardner, Paul A Luciw
Apr 18, 2009·Current Opinion in HIV and AIDS·Ronald S Veazey
Jun 27, 2009·Sexually Transmitted Diseases·Dorothy L PattonKathleen J Paul
Feb 9, 2012·The Indian Journal of Medical Research·Gita Ramjee
Sep 18, 2014·Journal of Controlled Release : Official Journal of the Controlled Release Society·Rute NunesJosé das Neves
Feb 19, 2008·Contraception·Christine K MauckKurt Barnhart
Dec 30, 2014·Advanced Drug Delivery Reviews·José A Fernández-RomeroMelissa Robbiani
Nov 14, 2006·Biologicals : Journal of the International Association of Biological Standardization·Ian McGowan
Dec 19, 2009·Pharmaceutical Development and Technology·David R Friend
Apr 18, 2009·Current Opinion in HIV and AIDS·Ian McGowan, Peter Anton

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