PMID- 15980697
OWN - NLM
STAT- MEDLINE
DCOM- 20050913
LR  - 20200930
IS  - 1525-4135 (Print)
IS  - 1525-4135 (Linking)
VI  - 39
IP  - 3
DP  - 2005 Jul 1
TI  - Safety, acceptability, and potential efficacy of a topical penile microbicide 
      wipe.
PG  - 347-53
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.
FAU - Taha, Taha E
AU  - Taha TE
AD  - Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD 21205, 
      USA. ttaha@jhsph.edu
FAU - Kumwenda, Newton
AU  - Kumwenda N
FAU - Mwakomba, Albert
AU  - Mwakomba A
FAU - Mwenda, Robin
AU  - Mwenda R
FAU - Kawonga, Harry
AU  - Kawonga H
FAU - Gaydos, Charlotte
AU  - Gaydos C
FAU - Hoover, Donald
AU  - Hoover D
FAU - Kafulafula, George
AU  - Kafulafula G
LA  - eng
GR  - D43-W00010/PHS HHS/United States
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (Anti-Infective Agents, Local)
RN  - 0 (Benzalkonium Compounds)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-Infective Agents, Local/*administration & dosage/adverse effects
MH  - Benzalkonium Compounds/*administration & dosage/adverse effects
MH  - Circumcision, Male
MH  - Gram-Negative Bacteria/drug effects/isolation & purification
MH  - Gram-Positive Bacteria/drug effects/isolation & purification
MH  - HIV/drug effects/isolation & purification
MH  - HIV Infections/prevention & control/transmission/virology
MH  - Humans
MH  - Malawi
MH  - Male
MH  - Middle Aged
MH  - Patient Acceptance of Health Care
MH  - Patient Compliance
MH  - Penis/*drug effects/*microbiology/virology
MH  - Safety
EDAT- 2005/06/28 09:00
MHDA- 2005/09/15 09:00
CRDT- 2005/06/28 09:00
PHST- 2005/06/28 09:00 [pubmed]
PHST- 2005/09/15 09:00 [medline]
PHST- 2005/06/28 09:00 [entrez]
AID - 00126334-200507010-00014 [pii]
AID - 10.1097/01.qai.0000148080.61202.70 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2005 Jul 1;39(3):347-53. doi: 
      10.1097/01.qai.0000148080.61202.70.