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02436 SAFETY, ACCEPTIBILITY AND EFFICACY OF A PENILE MICROBICIDE WIPE Taha, Taha* Innovative, low cost and practical preventive measures are needed to reduce acquisition of STIs. Two studies were conducted in Malawi to determine safety, acceptability and potential efficacy of a topical penile microbicide wipe, 0.4% bezalkonium Chloride (BZK). The first study was a phase I dose escalating clinical trial to assess safety and acceptability of pre- and post-coital penile cleaning. After obtaining consent, 27 uncircumcised and 24 circumcised low-risk, HIV negative men were enrolled. These men were followed for 8 weeks with penile wipe use escalating from none to a maximum of 3 a day. Compared to events during the first 2 weeks when no wipe was used, there were no changes in reported or confirmed adverse events (AEs) with escalation of dose during subsequent weeks. Adherence and acceptability were high (~90%) and did not differ with increasing dose. Among female partners of these men there were no reports of AEs. The second study assessed the efficacy of 0.4% BZK wipe to decrease the frequency of pathogens found on the mucosal surface of the penile foreskin. After consenting, 27 uncircumcised men were recruited from an STD clinic. The presence of pathogens before and after cleaning the penis with the wipe was quantitatively scored using wet mount, gram stain and culture. The frequency of almost all pathogens, including N. gonorrhoeae, significantly (p<0.05) decreased after cleaning with the wipe compared to rates before cleaning. These results suggest that this topical penile microbicide wipe is safe and acceptable. It was effective in reducing the frequency of several pathogens. A phase III trial is planned to further evaluate this wipe. Dr. Taha E. Taha |
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