Trial record 18 of 18 for:    " April 11, 2007":" May 11, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00469547
First received: May 3, 2007
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Sexually Transmitted Infections
Other: 62% ethanol in emollient gel
Drug: Placebo
Other: 15% ethanol in emollient gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety & Acceptance of 62% & 15% Ethanol in Emollient Gel as Topical Male Microbicides

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Self-reported urethral pain, urethral burning, penile itching, penile rash, penile blisters, penile ulceration or penile discharge. [ Time Frame: At follow-up clinic visits on days 7, 14, 28, 35, 42 or 56. ] [ Designated as safety issue: Yes ]
  • Adverse events other than those listed as primary endpoints judged related to product use. [ Time Frame: Varies ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Varies ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
62% ethanol in emollient gel
Other: 62% ethanol in emollient gel
62% ethanol in emollient gel used as a topical male microbicide
Other Name: Topical male microbicide
Placebo Comparator: 2
15% ethanol in emollient gel
Drug: Placebo
15% ethanol in emollient gel used as a topical male microbicide
Other Name: Topical male microbicide
Other: 15% ethanol in emollient gel
15% ethanol in emollient gel used as a topical male microbicide
Other Name: Topical male microbicide

Detailed Description:

In Kenya, the HIV/AIDS epidemic has significantly increased adult and child mortality. Current prevention options, including the ABC model (Abstinence, Be faithful and correct and consistent Condom use) have not been sufficient to curb the generalized HIV epidemic. The development of topical microbicides provides a potential new prevention option against sexually transmitted infections (STIs), including HIV. Despite widespread use of topical microbicides among U.S. servicemen during World Wars I & II to prevent STI, the current HIV agenda has thus far focused almost exclusively on microbicide research for intravaginal use by females. Research on use of topical microbicides on the male genitalia has only examined potential adverse effects on the penis of microbicides intended for intravaginal or rectal use. Further research is necessary to determine what formulations, what doses, and what types of topical antimicrobials might prove acceptable, and tolerable for external genital use by male sub-populations, and effective for preventing HIV/STI in men. This Phase 1 safety trial is the culmination of a stepwise series of studies examining male genital hygiene and safety and acceptance of an alcohol-based topical microbicide among Kenyan men. The purpose of this randomized, double-blinded, placebo-controlled, crossover trial is to assess the safety and acceptability of 62% ethanol in emollient gel (intervention) and 15% ethanol in emollient gel (placebo), applied to the penis by men each morning and after every sexual exposure. The study population will include 30 healthy, uncircumcised Kenyan men working in the fishing industry. Participants will be randomly assigned to initial use of 1 of the 2 products for a 2-week interval. After a subsequent 2-week wash out period in which no topical gel will be used, the men will then cross over to use of the second product. The primary study objective is to assess the safety and toxicity of 62% and 15% ethanol in emollient gel on the penile epithelium and urethral mucosa. The secondary study objective is to assess the acceptability and compliance with the topical microbicide (62% ethanol) and placebo (15% ethanol) by men each morning and after each act of sexual intercourse. The primary study outcome measures include: 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; erythema (with or without induration), vesiculation, bullous reaction, and ulceration, of the penile shaft, foreskin, and glans, as observed by visual exam at follow-up clinic visits on days 7, 14, 28, 35, 42, or 56; erythema or ulceration of the urethral meatus, as observed by visual exam at follow-up clinic visits on days 7, 14, 28, 35, 42 or 56; and adverse events other than those listed as primary endpoints judged related to product use. The secondary study outcome measures are reported positive attributes (ease of use, increased pleasure during sex, positive feedback from primary sex partner) or negative attributes (difficulty of use, decreased pleasure during sex, negative feedback from primary sex partner) of the study products; reported willingness to use and recommend the products; and reported adherence with use of condoms and of the topical microbicide. Each participant will take part in the study for up to 8 weeks, including the screening period. The entire study should be completed within 5-6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469547

Locations
Kenya
Kenya Medical Research Institute
Kisumu, Kenya
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: King K Holmes, MD, PhD University of Washington
Study Director: Elizabeth Bukusi, MBChB, MPH, PhD Kenya Medical Research Institute/University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: King Holmes, MD, PhD, University of Washington
ClinicalTrials.gov Identifier: NCT00469547     History of Changes
Other Study ID Numbers: 30225-D, KEMRI HSD #SCC931; 06-0040
Study First Received: May 3, 2007
Last Updated: April 28, 2009
Health Authority: Kenya: KEMRI/National Ethical Review Committee

Keywords provided by University of Washington:
ethanol, microbicide, sexually transmitted, Kenya, males
HIV Seronegativity

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Ethanol
Anti-Infective Agents
Emollients
Anti-Infective Agents, Local
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 18, 2014