A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides
Completed · Early Phase 1
Conditions studied: HIV Infections
In brief
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 flexible sigmoidoscopy.
Key facts
- Study ID
- NCT00389311
- Run by
- Johns Hopkins University
- People needed
- 12
- Starts
- 2007-04-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2015-04-01
Who can join
Age: 21 and older. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.