TY - JOUR
T1 - Safety, acceptability, and potential efficacy of a topical penile microbicide wipe
AU - Taha, Taha E.
AU - Kumwenda, Newton
AU - Mwakomba, Albert
AU - Mwenda, Robin
AU - Kawonga, Harry
AU - Gaydos, Charlotte
AU - Hoover, Donald
AU - Kafulafula, George
PY - 2005/7/1
Y1 - 2005/7/1
N2 - Innovative, low-cost, and acceptable measures are needed to reduce sexually transmitted infections (STIs) including HIV Use of a topical microbicide wipe for penile cleaning before and after sex might be effective in preventing STIs. However, evaluation of this simple method has not been done. 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 1 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 3 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.
AB - Innovative, low-cost, and acceptable measures are needed to reduce sexually transmitted infections (STIs) including HIV Use of a topical microbicide wipe for penile cleaning before and after sex might be effective in preventing STIs. However, evaluation of this simple method has not been done. 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 1 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 3 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.
KW - Benzalkonium chloride
KW - HIV
KW - Microbicide
KW - Penile wipe
KW - Sexually transmitted infections
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U2 - 10.1097/01.qai.0000148080.61202.70
DO - 10.1097/01.qai.0000148080.61202.70
M3 - Article
C2 - 15980697
AN - SCOPUS:21544435424
SN - 1525-4135
VL - 39
SP - 347
EP - 353
JO - Journal of Acquired Immune Deficiency Syndromes
JF - Journal of Acquired Immune Deficiency Syndromes
IS - 3
ER -