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

• Status: Completed
• Trial end date: 2019-03-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AIDS Healthcare Foundation
• Collaborator: HIV Immunotherapeutics Institute
• Treatments: Mesalamine

Criteria

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