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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00069498
First received: September 26, 2003
Last updated: May 24, 2007
Last verified: July 2006

September 26, 2003
May 24, 2007
October 1999
Not Provided
Safety of 4.8 g/day 5-ASA in HIV infected patients with detectable viral load
Not Provided
Complete list of historical versions of study NCT00069498 on ClinicalTrials.gov Archive Site
  • Time/trend decrease in mucosal viral RNA load and plasma viral RNA load, compared to placebo
  • reduction in cellular infiltration in treated patients versus those taking placebo
  • change in inflammation, as measured by tissue destruction
  • reduction in soluble inflammation (RANTES), CCR5 expression, and cellular infiltration of CD8
  • changes in certain activation markers in gut
Not Provided
Not Provided
Not Provided
 
Effect of an Anti-Inflammatory Drug on Gut Mucosa in HIV Infected Patients
Impact of Co-Receptor and HIV Viral Burden on Gut Mucosa

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.

The gastrointestinal tract is the body’s largest lymphoid organ. Because it contains significant numbers of activated memory T lymphocytes, it is a prime site for HIV infection and amplification. Mucosal T cells are extremely vulnerable to HIV infection due, in part, to a marked increase in CCR5 co-receptors. Understanding the impact of HIV on the gastrointestinal-associated lymphoid tissue (GALT) is essential and may provide insight into the profound drop in mucosal lymphocytes during early infection, persistence of tissue viral replication in the setting of undetectable plasma viral activity, and compartmentalization of HIV.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: 5-aminosalicylic acid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
Not Provided
Not Provided

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00069498
K24AI01610-03, K24 AI01610-03
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Peter A. Anton, MD University of California, Los Angeles
National Institute of Allergy and Infectious Diseases (NIAID)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP