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

Completed · Phase 1/Phase 2

Conditions studied: HIV-1-infection, Gut Inflammation

In brief

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

Key facts

Study ID

NCT03399903

Run by

AIDS Healthcare Foundation

People needed

47

Starts

2017-05-01

Expected to finish

2019-03-22

Last updated by the study team

2020-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AIDS Healthcare Foundation - Public Health Division — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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