Mesalamine to Reduce T Cell Activation in HIV Infection

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to determine whether 12 weeks of mesalamine therapy added to a standard HIV treatment decreases systemic immune activation and inflammation in HIV-infected patients, possibly resulting in better recovery of the immune system. The study hypothesis is that decreasing inflammation directly in the gut may decrease both of these potential causes of chronic inflammation, potentially resulting in an immunologic benefit.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Bausch Health Americas, Inc.; California HIV/AIDS Research Program; Valeant Pharmaceuticals International, Inc.
• Treatments: Aminosalicylic Acid; Mesalamine

Criteria

Inclusion Criteria:

1. HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry.

2. Stable antiretroviral therapy for at least 6 months.

3. Screening CD4+ T cell count below 350 cells/mm3

4. All available CD4+ T cell counts in the last year and at screening <350 cells/mm3

5. Screening plasma HIV RNA levels below level of detection (< 40 copies RNA/mL).

6. All available plasma HIV RNA levels within past year below the level of detection. Isolated detectable values < 500 c/ml are allowed if HIV RNA levels before and after this time point are undetectable.

7. >90% adherence to therapy within the preceding 30 days, as determined by self-report.

8. Both male and female subjects are eligible. Females of childbearing potential must have negative pregnancy test at screening and agree to use a double-barrier method of contraception during the study.

Exclusion Criteria:

1. Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason.

2. Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.

3. Exposure to any immunomodulatory drug in the past 16 weeks.

4. Active hepatitis C or hepatitis B which will require treatment in the subsequent 24 weeks.

5. Screening absolute neutrophil count <1,000 cells/mm3, platelet count <50,000 cells/mm3, Hgb < 8mg/dL

6. Pancreatitis or lipase greater than 2 times the upper limit of normal.

7. Renal insufficiency with creatinine clearance less than 50 ml/min

8. Elevated transaminases greater than 2.5 times the upper limit of normal.

9. Evidence of decompensated cirrhosis, heart failure.

10. Pregnant or breastfeeding women