Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk
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ClinicalTrials.gov Identifier: NCT02272946 |
Recruitment Status :
Completed
First Posted : October 23, 2014
Results First Posted : April 20, 2023
Last Update Posted : April 20, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Cardiovascular Disease | Drug: Canakinumab Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | February 2021 |
Actual Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Safety Arm
In Stage 1: all 10 subjects will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
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Drug: Canakinumab
150mg Canakinumab received subcutaneously
Other Name: IL--1β |
Experimental: Canakinumab
In Stage II: About 67 subjects will receive 150mg Canakinumab subcutaneous injection.
|
Drug: Canakinumab
150mg Canakinumab received subcutaneously
Other Name: IL--1β |
Placebo Comparator: Placebo
In Stage II: About 33 subjects will receive 150mg placebo subcutaneous injection
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Drug: Placebo
150mg Placebo received subcutaneously |
- Change in CD4 Count From Baseline to Follow-up [ Time Frame: weeks 4, 8, 12, 18, 24, and 36. ]Change in CD4 count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
- Change in CD8 Count From Baseline to Follow-up [ Time Frame: weeks 4, 8, 12, 18, 24, and 36. ]Change in CD8 count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
- Change in Absolute Neutrophil Count From Baseline to Follow-up [ Time Frame: weeks 4, 8, 12, 18, 24, and 36. ]Change in absolute neutrophil count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
- Change in Platelet Count From Baseline to Follow-up [ Time Frame: weeks 4, 8, 12, 18, 24, and 36. ]Change in platelet count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
- Change in Creatinine Count From Baseline to Follow-up [ Time Frame: weeks 4, 8, 12, 18, 24, and 36. ]Change in creatinine count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
- Change in AST From Baseline to Follow-up [ Time Frame: weeks 4, 8, 12, 18, 24, and 36. ]Change in AST from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
- Change in ALT From Baseline to Follow-up [ Time Frame: weeks 4, 8, 12, 18, 24, and 36. ]Change in ALT from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
- Flow-Mediated Dilation (FMD) [ Time Frame: Baseline and Week 12 ]Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter
- Arterial Inflammation Measured at Baseline and Follow-up at Week 12 [ Time Frame: Baseline (entry) and Week 12 ]Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT and reported as target-to-background (TBR) ratio to measure of vascular inflammation
- D-Dimer [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and week 18 ]D-Dimer will be assessed from baseline to weeks 4, 8, 12, and 18.
- Human Serum Amyloid A (SAA) [ Time Frame: Baseline, 4 weeks, 12 weeks, and week 18 ]SAA will be assessed from baseline to weeks 4, 12, and 18.
- Tumor Necrosis Factor Alpha (TNFa) [ Time Frame: Baseline, 4 weeks, 12 weeks, and week 18 ]TNFa will be assessed from baseline to weeks 4, 12, and 18.

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Ages Eligible for Study: | 40 Years to 59 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272946
United States, California | |
San Francisco General Hospital | |
San Francisco, California, United States, 94110 |
Principal Investigator: | Priscilla Hsue, MD | University of California, San Francisco |
Documents provided by Priscilla Hsue, MD, University of California, San Francisco:


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Priscilla Hsue, MD, Professor of Medicine, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT02272946 |
Other Study ID Numbers: |
Canakinumab |
First Posted: | October 23, 2014 Key Record Dates |
Results First Posted: | April 20, 2023 |
Last Update Posted: | April 20, 2023 |
Last Verified: | March 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cardiovascular Diseases Inflammation Pathologic Processes |