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Enema Use and Acceptability in HIV Negative Men Who Have Sex With Men

This study has been completed.
University of California, Los Angeles
Information provided by (Responsible Party):
Craig W. Hendrix, Johns Hopkins University Identifier:
First received: June 4, 2008
Last updated: March 30, 2015
Last verified: August 2009
This study is looking at 3 different types of enemas used before receptive anal intercourse in men who have sex with men (MSM). We are investigating whether the enemas cause any damage to the lining of the colon, how far up the colon the enemas travel after they are given, and how much study participants like using each of the enemas.

Condition Intervention
HIV Infections
Drug: Fleets enema
Drug: tap water enema
Drug: Normosol-R enema

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Blinded, Comparative Study of the Mucosal Toxicity, Colorectal Distribution, and Participant Acceptability of Three Different Preparatory Enemas (Hypo-, Iso-, and Hyper-osmolar)

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • To evaluate the mucosal toxicity of enemas of varying osmolality [ Time Frame: One year ]

Enrollment: 9
Study Start Date: July 2007
Study Completion Date: March 2012
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Fleets enema
hyper-osmolar preparation
Experimental: B Drug: tap water enema
hypo-osmolar preparation
Experimental: C Drug: Normosol-R enema
iso-osmolar preparation


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male
  • ≥ Age of 18
  • HIV-1 status antibody negative as documented at screening
  • A history of RAI at least twice per month in the prior 3 months*

    • Required to assure that subjects are likely to complete each stage of enema test article use in a reasonable amount of time.
  • History of enema use prior to RAI at least some of the time
  • Willing to use each study product prior to RAI on 3 separate occasions.
  • Willing to refrain from RAI for 48 hours before and after inpatient periods.
  • Willing to use condoms for the duration of the study
  • Availability to return for all study visits, barring unforeseen circumstances
  • Understands and agrees to local STI reporting requirements
  • Able and willing to communicate in English
  • Able and willing to provide written informed consent to take part in the study
  • Able and willing to provide adequate information for locator purposes

Exclusion Criteria:

  • Female
  • HIV positive at baseline
  • History of inflammatory bowel disease
  • Active inflammatory condition of the GI tract at baseline
  • Active rectal infection at Visit 2 (Infections identified during the screening period must be treated prior to Visit 2)
  • Presence of any painful anorectal conditions that would be tender to manipulation. (Participants with hemorrhoids and/or anal warts that are not painful may participate.)
  • History of prosthetic cardiac valves, including bioprosthetic and homograft valves, previous bacterial endocarditis, surgically constructed systemic pulmonary shunts or conduits, and complex cyanotic congenital heart disease such as single ventricle states, transposition of the great arteries, tetralogy of Fallot or similar conditions that put the subject at high risk for bacteremia during endoscopy, hence requiring antibiotic prophylaxis.
  • Unwillingness to refrain from chronic use of aspirin and NSAIDs.
  • Use of warfarin or heparin
  • Use of systemic immunomodulatory medications within 72 hours of Visit 2 baseline
  • Use of rectally administered medications, including over-the-counter enemas, within 72 hours of Visit 2 baseline
  • Use of product containing nonoxyl-9 rectally within 72 hours of Visit 2
  • Use of any investigational products within 72 hours of Visit 2 baseline
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral disease, or coagulopathies.
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Please refer to this study by its identifier: NCT00696618

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
University of California, Los Angeles
Principal Investigator: Craig Hendrix, MD Johns Hopkins University
  More Information

Responsible Party: Craig W. Hendrix, Professor, Department of Medicine, Johns Hopkins University Identifier: NCT00696618     History of Changes
Other Study ID Numbers: NA_00010972
Study First Received: June 4, 2008
Last Updated: March 30, 2015

Keywords provided by Johns Hopkins University:
HIV prevention
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on April 21, 2017