Status:
COMPLETED
Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk
Lead Sponsor:
Priscilla Hsue, MD
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
HIV
Cardiovascular Disease
Eligibility:
All Genders
40-59 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures of systemic and vascular inflammation and endothelial function (all indicators of cardiovascular risk) in t...
Eligibility Criteria
Inclusion
- HIV infection,
- Age ≥ 40 years \< 60 years
- On continuous ART for at least 12 months with no change in regimen in 12 weeks prior to study entry
- CD4+ T cell count ≥ 400 cells/mm3
- HIV RNA level below the standard limit of quantification for 52 weeks prior to entry
- High risk for CAD as defined by either documented CVD (including prior MI) or diabetes mellitus or 1 CVD risk factor (current smoking, hypertension, dyslipidemia, or hsCRP≥2mg/L.)
- Individuals on stable doses of lipid lowering therapy and/or anti-hypertensive medication will be allowed in the study.
- Appropriate documentation from medical records of prior receipt of pneumococcal vaccinations
Exclusion
- Women of childbearing potential or pregnant/nursing women
- CABG surgery in the past 3 years
- Class IV heart failure
- Uncontrolled HTN
- History of tuberculosis or latent TB that is not treated
- Nephrotic syndrome or eGFR\< 30 ml/min/1.73m2
- Active hepatic disease or active/chronic hepatitis B or C
- Any prior malignancy including KS
- Serious illness requiring hospitalization or active infection requiring antibiotics within 90 days
- Requirement for live active vaccination 3 months prior to, during, and 3 months after study
- Concurrent immune modulating therapy
- Diabetes Mellitus
- History of multiple imaging studies associated with radiation exposure
- Neutropenia defined as ANC\<1500/mm
- Triglycerides\>400 mg/dL
- History of hypersensitivity to study drug
- History of EBV-related lymphoproliferative disorders
- Active or untreated latent TB infection
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02272946
Start Date
September 1 2015
End Date
December 1 2021
Last Update
April 20 2023
Active Locations (1)
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1
San Francisco General Hospital
San Francisco, California, United States, 94110