62% & 15% Ethanol in Emollient Gel as Topical Male Microbicides
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to look at the safety and acceptance of using a microbicide
(product that kills germs) gel to clean the genital area. Microbicide gel is used by hospital
workers to clean their hands to kill germs. Researchers hope to use information from this
study to conduct a larger study to determine if the microbicidal gel protects men against
sexually transmitted infections, including HIV. Thirty healthy uncircumcised Kenyan men, 18
years and older, working in the fishing industry in Kisumu will be recruited. Participants
will complete a questionnaire about their background and sexual practices. A researcher will
conduct a detailed examination of the genital area with a magnifying glass. A blood and urine
sample will be collected to test for infection. Each participant will use both the
microbicidal gel and a placebo (contains no active ingredient) gel at different times during
the study, and the results will be compared. Volunteers will participate up to 8 weeks.
Phase:
Phase 1
Details
Lead Sponsor:
University of Washington
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)