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

April 28, 2009 updated by: University of Washington

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • Kenya Medical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Topical male microbicide
Other: 15% ethanol in emollient gel
15% ethanol in emollient gel used as a topical male microbicide
Other Names:
  • Topical male microbicide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
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.
Time Frame: Varies
Varies

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Varies

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: King K Holmes, MD, PhD, University of Washington
  • Study Director: Elizabeth Bukusi, MBChB, MPH, PhD, Kenya Medical Research Institute/University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 30225-D
  • KEMRI HSD #SCC931; 06-0040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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