Phase 4
N=33
Mesalamine to Reduce T Cell Activation in HIV Infection
HIV Infections · Sexually Transmitted Diseases · Immune System Diseases · Lentivirus Infections · Acquired Immunodeficiency Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01090102 ↗Enrolled (actual)
33
Serious AEs
3.3%
Results posted
Aug 2014
Primary outcome: Primary: Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study — 0.03; -0.01 Log10(percentage of T cells) — p=0.63
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mesalamine (5-aminosalicylic acid, Apriso) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study |
0.03; -0.01 | 0.63 |
| SECONDARY Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells After Treatment Crossover |
0.003; -0.03 | 0.77 |
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
- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry.
- Stable antiretroviral therapy for at least 6 months.
- Screening CD4+ T cell count below 350 cells/mm3
- All available CD4+ T cell counts in the last year and at screening 90% adherence to therapy within the preceding 30 days, as determined by self-report.
- 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
- Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason.
- Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
- Exposure to any immunomodulatory drug in the past 16 weeks.
- Active hepatitis C or hepatitis B which will require treatment in the subsequent 24 weeks.
- Screening absolute neutrophil count <1, 000 cells/mm3, platelet count <50,000 cells/mm3, Hgb < 8mg/dL
- Pancreatitis or lipase greater than 2 times the upper limit of normal.
- Renal insufficiency with creatinine clearance less than 50 ml/min
- Elevated transaminases greater than 2.5 times the upper limit of normal.
- Evidence of decompensated cirrhosis, heart failure.
- Pregnant or breastfeeding women
Data sourced from ClinicalTrials.gov (NCT01090102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.