Effect of an Anti-Inflammatory Drug on Gut Mucosa in HIV Infected Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The lining of the gastrointestinal tract contains specialized lymphoid tissue that is part of the immune system. Like other parts of the immune system, HIV attacks this lymphoid tissue. This study will evaluate the effect of an anti-inflammatory drug on the lymphoid tissue in the gastrointestinal tracts of people with HIV.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aminosalicylic Acid; Anti-Inflammatory Agents; Mesalamine

Criteria

Inclusion Criteria

• HIV infected

• 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

• Allergy or intolerance to salicylates

• 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