September 2005 Cover
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Two studies were conducted in Malawi to determine the safety, acceptability, and potential efficacy of a benzalkonium chloride topical penile microbicide wipe.
The first study was a phase one dose-escalating clinical trial among low-risk circumcised or uncircumcised HIV-negative men.
The second study was a pilot before-after efficacy study among uncircumcised HIV-negative or -positive men.
In the first study 24 circumcised and 27 uncircumcised men were enrolled. During the entire study period, 18 adverse events (AEs) were reported, and three AEs were confirmed
by physical examination. Acceptability concerns did not increase with dose escalation, and adherence to use of the wipe ranged from 89%-95%.
In the second study, 27 men were enrolled. Gram stain and culture tests showed significant reductions in frequency of several organisms after use of the wipe, including
STI-associated bacteria.
This penile wipe is safe, acceptable, and can decrease the frequency of penile colonization with microorganisms.
The clinical relevance remains to be determined in larger clinical trials.
Editor's Note: from the Journal of AIDS
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