Trial record 6 of 39 for:    " May 07, 2008":" June 06, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00696618
First received: June 4, 2008
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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 (Subject, 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 ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: July 2007
Study Completion Date: July 2009
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00696618

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

No publications provided

Responsible Party: Craig Hendrix, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00696618     History of Changes
Other Study ID Numbers: NA_00010972
Study First Received: June 4, 2008
Last Updated: August 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
HIV prevention
MSM
Enema
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Sodium phosphate
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014