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

NCT00469547 | Completed Phase 1 DMC

• 2 other identifiers: 30225-DKEMRI HSD #SCC931; 06-0040
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sexually Transmitted Infections

Keywords

ethanol, microbicide, sexually transmitted, Kenya, males; HIV Seronegativity

Outcome Measures

Primary Outcomes (2)

• Self-reported urethral pain, urethral burning, penile itching, penile rash, penile blisters, penile ulceration or penile discharge.

  At follow-up clinic visits on days 7, 14, 28, 35, 42 or 56.

• Adverse events other than those listed as primary endpoints judged related to product use.

  Varies

Secondary Outcomes (1)

• Reported positive attributes or negative attributes of the study products, willingness to use and recommend the products, adherence with use of condoms and of the topical microbicide.

  Varies

Study Arms (2)

1

EXPERIMENTAL

62% ethanol in emollient gel

Other: 62% ethanol in emollient gel

2

PLACEBO COMPARATOR

15% ethanol in emollient gel

Drug: Placebo; Other: 15% ethanol in emollient gel

Interventions

62% ethanol in emollient gel OTHER

62% ethanol in emollient gel used as a topical male microbicide

Also known as: Topical male microbicide

1

Placebo DRUG

15% ethanol in emollient gel used as a topical male microbicide

Also known as: Topical male microbicide

2

15% ethanol in emollient gel OTHER

15% ethanol in emollient gel used as a topical male microbicide

Also known as: Topical male microbicide

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Kenya

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• King K Holmes, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Elizabeth Bukusi, MBChB, MPH, PhD

  Kenya Medical Research Institute/University of Washington

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 30, 2009

Record last verified: 2009-04

Locations

KE (1)