Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection

Study Overview
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Brief Summary
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An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.

Detailed Description
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The goal of this study is to test whether a bowel anti-inflammatory drug that is known to be safe and effective for inflammatory bowel disease would offer benefit in reducing the residual immune activation associated with treated HIV-1 infection. Specifically, the two immediate goals are to examine the safety of Pentasa® in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.

Official Title
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Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection

Conditions
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HIV-1-infection, Gut Inflammation

Intervention / Treatment
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* Drug: Pentasa vs Align


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 18 On ART for at least 1 year during which: viremia <50 RNA copies/ml for at least 3 measurements (allowing for 1 nonconsecutive blip of <100), and CD4 T cell count consistently >500 during that time CD4 T cell nadir >350 Last CD4 and T cell test in past 6 months Exclusion Criteria: Plans to modify antiretroviral therapy in the next 12 weeks for any reason History of inflammatory bowel disease or irritable bowel disease Chronic active hepatitis B or C History of autoimmune disease Hypersensitivity to any component of Pentasa Clostridium difficile infection Receiving rectally delivered medications Receiving anti-inflammatory medications (such as nonsteroidal anti- inflammatory drugs, steroids, or TNF inhibitors) Receiving immunosuppressive steroids Receiving any medications associated with bleeding risk Hemoglobin < 10.0 g/dL Platelet count less than 100,000/mm3 White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3 Symptoms of sexually transmitted infection Antibiotics used in the last 90 days 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pentasa<br>40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks | Drug: Pentasa vs Align<br>* We will examine the safety and possible effectiveness of Pentasa® and Align in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.<br>|
| Active Comparator: Align<br>40 participants will be randomized to take Align tablets, once daily for 8 weeks | Drug: Pentasa vs Align<br>* We will examine the safety and possible effectiveness of Pentasa® and Align in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation markers | C-reactive protein | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow cytometry for cellular immune activation | Immune activation | 14 weeks | 
| Plasma markers of microbial translocation | Microbial translocation | 14 weeks |