Status:
COMPLETED
Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection
Lead Sponsor:
AIDS Healthcare Foundation
Collaborating Sponsors:
HIV Immunotherapeutics Institute
Conditions:
HIV-1-infection
Gut Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.
Detailed Description
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 activ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2019
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03399903
Start Date
May 1 2017
End Date
March 22 2019
Last Update
March 4 2020
Active Locations (1)
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1
AIDS Healthcare Foundation - Public Health Division
Los Angeles, California, United States, 90027