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

May 24, 2007 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety of 4.8 g/day 5-ASA in HIV infected patients with detectable viral load

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Peter A. Anton, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Study Registration Dates

First Submitted

September 26, 2003

First Submitted That Met QC Criteria

September 29, 2003

First Posted (Estimate)

September 30, 2003

Study Record Updates

Last Update Posted (Estimate)

May 25, 2007

Last Update Submitted That Met QC Criteria

May 24, 2007

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K24AI001610-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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