Mesalamine to Reduce T Cell Activation in HIV Infection
Condition: HIV Infections; Sexually Transmitted Diseases; Immune System Diseases; Lentivirus Infections; Acquired Immunodeficiency Syndrome
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; Lentivirus Infections; Immunologic Deficiency Syndromes; Immune System Diseases
Intervention: Mesalamine (5-aminosalicylic acid, Apriso); Placebo
Intervention description: Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth).
Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).; Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth).
Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
Intervention MeSH terms: Aminosalicylic Acid; Mesalamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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