| June 4, 2008 |
| August 3, 2009 |
| July 2007 |
| July 2009 (final data collection date for primary outcome measure) |
| To evaluate the mucosal toxicity of enemas of varying osmolality [ Time Frame: One year ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00696618 on ClinicalTrials.gov Archive Site |
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| Enema Use and Acceptability in HIV Negative Men Who Have Sex With Men |
| A Randomized, Blinded, Comparative Study of the Mucosal Toxicity, Colorectal Distribution, and Participant Acceptability of Three Different Preparatory Enemas (Hypo-, Iso-, and Hyper-osmolar) |
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. |
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| Interventional |
| Prevention, Randomized, Double Blind (Subject, Investigator), Single Group Assignment |
| HIV Infections |
- Drug: Fleets enema
- Drug: tap water enema
- Drug: Normosol-R enema
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| Completed |
| 9 |
| July 2009 |
| July 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
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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| Male |
| 18 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00696618 |
| Craig Hendrix, MD, Johns Hopkins University |
| NA_00010972 |
| Johns Hopkins University |
| University of California, Los Angeles |
| Principal Investigator: |
Craig Hendrix, MD |
Johns Hopkins University |
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| Johns Hopkins University |
| August 2009 |