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Sponsors and Collaborators: |
Johns Hopkins University University of California, Los Angeles |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00696618 |
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 |
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HIV Infections |
Drug: Fleets enema Drug: tap water enema Drug: Normosol-R enema |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Single Group Assignment |
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) |
Estimated Enrollment: | 9 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Fleets enema
hyper-osmolar preparation
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B: Experimental |
Drug: tap water enema
hypo-osmolar preparation
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C: Experimental |
Drug: Normosol-R enema
iso-osmolar preparation
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A history of RAI at least twice per month in the prior 3 months*
Exclusion Criteria:
Contact: Elizabeth Purdy | 410-614-0142 | epurdy4@jhmi.edu |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Elizabeth Purdy 410-614-0142 epurdy4@jhmi.edu | |
Principal Investigator: Craig Hendrix, MD |
Principal Investigator: | Craig Hendrix, MD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University ( Craig Hendrix, MD ) |
Study ID Numbers: | NA_00010972 |
Study First Received: | June 4, 2008 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00696618 |
Health Authority: | United States: Institutional Review Board |
HIV prevention MSM Enema HIV Seronegativity |
Virus Diseases Sodium phosphate Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Hyperkinesis Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Therapeutic Uses Gastrointestinal Agents |
Lentivirus Infections Cathartics Infection Pharmacologic Actions |