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02343_3 PRECLINICAL SAFETY EVALUATION OF ACIDFORM IN THE MACAQUE MODEL Cosgrove Sweeney, Yvonne ACIDFORM is an acid-buffering formulation that was evaluated for preclinical safety in NIH- contracted macaque studies as a topical microbicide. In these standardized studies, four daily applications of topical microbicide product are delivered vaginally. Immediately prior to each application, tissues are assessed by colposcopy, microbiology, and pH. Thirty minutes after product application, microbiology and pH are assessed again, to understand product-induced alterations to the cervicovaginal environment present at a potential time of pathogen exposure. Repeat assessments are made 24 hours and three days after the final product application to document recovery. Additionally, vaginal and cervical tissue biopsies collected one day after the final product application are assessed histologically for inflammatory infiltrate. No abnormal colposcopic observations were noted in any animals. The vaginal microbiology remained largely unchanged throughout the experiment in test and placebo animals. Populations of H2O2-producing lactobacilli and viridans streptococci fluctuated slightly in animals treated with ACIDFORM, though no pattern of product-induced suppression of these organisms emerged. Vaginal pH consistently decreased (in general was measured at 4.0 4.5) in all animals at 30 minutes after test gel application. Vaginal and cervical biopsy specimens collected 24 hours after the 4th gel application showed no signs of product induced inflammatory infiltrate. ACIDFORM was kindly provided for testing by CONRAD. This work supported by NIH contract N01-AI-95388 and U of WA National Primate Research Center RR-00166 Yvonne Cosgrove Sweeney |
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