62% & 15% Ethanol in Emollient Gel as Topical Male Microbicides

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Male

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Anti-Infective Agents; Emollients; Ethanol

Criteria

Inclusion Criteria:

• Male

• 18 years or older

• Working in the fishing industry for at least 3 months and living and working along the shores of Lake Victoria within a 70km radius of Kisumu, Kenya

• Uncircumcised

• Sexually active (have had sex in the last 2 weeks)

• Commercial or transactional sex during the past month

• Inconsistent condom use (less than 25% of all sex acts)

• Ability & willing to attend the clinic for a eight week period

Exclusion Criteria:

• STI diagnosis on clinical examination

• History of or evidence of dermatological inflammation (e.g. balanitis, phimosis, swelling of prepuce, warts on penis) upon clinical examination

• History of genital ulcer disease, penile trauma, dyspareunia (pain during sex), foreskin tears

• Congenital abnormalities: hypospadias, epispadias

• HIV, HSV-2 and syphilis-seropositive

• LE positive

• History of allergic reaction to alcohol products.

• Preference for oral sex

• Participating in HIV/HSV-2 or participated male circumcision studies based in Kisumu

• Investigator discretion