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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00069498
First Posted: September 30, 2003
Last Update Posted: May 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
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.

Condition Intervention Phase
HIV Infections Drug: 5-aminosalicylic acid Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Impact of Co-Receptor and HIV Viral Burden on Gut Mucosa

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Safety of 4.8 g/day 5-ASA in HIV infected patients with detectable viral load

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 14
Study Start Date: October 1999
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00069498


Locations
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Peter A. Anton, MD University of California, Los Angeles
  More Information

ClinicalTrials.gov Identifier: NCT00069498     History of Changes
Other Study ID Numbers: K24AI001610-03 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2003
First Posted: September 30, 2003
Last Update Posted: May 25, 2007
Last Verified: July 2006

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Mucosa
Inflammation
Tissue Viral Load
Anti-inflammatory
HIV-related diarrhea
Mucosal Inflammation
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Inflammatory Agents
Mesalamine
Aminosalicylic Acid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents