Effect of an Anti-Inflammatory Drug on Gut Mucosa in HIV Infected Patients
NCT ID: NCT00069498
Last Updated: 2007-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
1999-10-31
Brief Summary
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Detailed Description
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Pre-clinical studies have demonstrated that the mucosal compartment in HIV uninfected individuals is characterized by features which enhance vulnerability to HIV infection compared to blood. Once infected, the mucosal response to HIV is inflammation. This study will further evaluate the inflammatory response of mucosal tissue to HIV by examining the effect of the anti-inflammatory drug 5-aminosalicylic acid (5-ASA) on the gut mucosa.
Participants in this study will be randomly assigned to receive either 5-ASA or placebo. Participants will be enrolled in the study for 8 weeks; participants may then elect to continue on 5-ASA for an additional 16 weeks. Participants will have four screening visits in the month prior to beginning the study and four study visits during the 8-week study. Assessments will include medical interviews and physical exams, sigmoidoscopy with mucosal biopsy, and blood tests.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Interventions
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5-aminosalicylic acid
Eligibility Criteria
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Inclusion Criteria
* Stable plasma viral load between 500 and 100,000 copies/ml for 3 months prior to study entry
* Stable antiretroviral therapy for at least 3 months prior to study entry
* CD4 cell count greater than or equal to 200 cells/mm3
* Mucosal viral RNA greater than or equal to 100 copies/microg total RNA within 2 weeks of study entry
Exclusion Criteria
* Gastrointestinal tract infection causing diarrhea or colonic inflammation
* Renal or hepatic disease
* Current opportunistic infection
* History of extensive small bowel resection (greater than 1/2 the length of the small intestine)
* History of intestinal mucosal disease (except HIV)
* Chronic, regular use of aspirin and/or anti-inflammatory agents within 7 weeks prior to study entry
* Oral, topical, or rectal steroids or 5-ASA within 3 months prior to study entry
* Certain laboratory abnormalities
* Significant neuropsychiatric symptoms that in the opinion of the study official could impact the conduct or outcome of the study
18 Years
65 Years
MALE
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Peter A. Anton, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Countries
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