Status:
COMPLETED
A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides
Lead Sponsor:
Johns Hopkins University
Conditions:
HIV Infections
Eligibility:
MALE
21+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to determine if detectable changes in permeability of the lining of the colon are caused by either application of HIV microbicide gels or medical procedures, such as flexi...
Detailed Description
It is not currently known if procedures used to observe the lining of the distal colon, such as endoscopy with or without pinch biopsy, may cause mucosal trauma and thus alter colonic permeability. Ad...
Eligibility Criteria
Inclusion
- Greater than or equal to 21 years of age
- Prior history of receptive anal intercourse (RAI)
- Subjects must have a history of using commercially-available personal lubricants for RAI.
- Ability to provide signed informed consent.
- Willingness to abstain from lubricant use and anal receptive intercourse for 48 hours prior to and 48 hours after Phases A and B.
- Willingness to use a single dose of rectally-applied N-9.
Exclusion
- Mental handicap or impaired cognitive performance status as judged by the investigator.
- Coagulation abnormality which would put the subject at risk for bleeding as judged by the Principal Investigator.
- History of anorectal surgery within the last month or the presence of any anorectal disease or condition that in the judgment of the investigator could affect permeability of the rectal mucosa.
- Presence of any painful anorectal conditions or anorectal lesions that would be tender to manipulation.
- History of occupational radiation exposure.
- History of acute or chronic diarrhea defined as three or more loose stools per day.
- History of any allergic response to rectal lubricants.
- History of sleep apnea, or airway problems with previous sedation procedures.
- History of significant adverse reaction to sedation medications.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00389311
Start Date
April 1 2007
End Date
June 1 2009
Last Update
April 1 2015
Active Locations (1)
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1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287