Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk
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ClinicalTrials.gov Identifier: NCT02272946 |
Recruitment Status :
Active, not recruiting
First Posted : October 23, 2014
Last Update Posted : November 10, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Cardiovascular Disease | Drug: Canakinumab Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 110 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 |
Estimated Study Completion Date : | December 2022 |

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 |
- Number of Adverse Events at week 1 as a measure of safety [ Time Frame: Week 1 ]Toxicities will be assessed and adverse events will be recorded at the study visit, including abnormal lab values for the following list of labs: CBC, AST, ALT, bilirubin, creatinine, glucose
- Number of Adverse Events at week 2 as a measure of safety [ Time Frame: Week 2 ]Toxicities will be assessed and adverse events will be recorded at the study visit, including abnormal lab values for the following list of labs: CBC, AST, ALT, bilirubin, creatinine, glucose
- Number of Adverse Events at week 4 as a measure of safety [ Time Frame: Week 4 ]Toxicities will be assessed and adverse events will be recorded at the study visit, including abnormal lab values for the following list of labs: CBC, AST, ALT, bilirubin, creatinine, glucose, CD4 count, HIV-1 RNA
- Number of Adverse Events at week 8 as a measure of safety [ Time Frame: Week 8 ]Toxicities will be assessed and adverse events will be recorded at the study visit, including abnormal lab values for the following list of labs: CBC, AST, ALT, bilirubin, creatinine, glucose, CD4 count, HIV-1 RNA
- Number of Adverse Events at week 12 as a measure of safety [ Time Frame: Week 12 ]Toxicities will be assessed and adverse events will be recorded at the study visit, including abnormal lab values for the following list of labs: CBC, AST, ALT, bilirubin, creatinine, glucose, CD4 count, HIV-1 RNA
- Number of Adverse Events at week 18 as a measure of safety [ Time Frame: Week 18 ]Toxicities will be assessed and adverse events will be recorded at the study visit, including abnormal lab values for the following list of labs: CBC, AST, ALT, bilirubin, creatinine, glucose
- Number of Adverse Events at baseline as a measure of safety [ Time Frame: Baseline ]Toxicities will be assessed and adverse events will be recorded at the study visit, including abnormal lab values for the following list of labs: CBC, AST, ALT, bilirubin, creatinine, glucose
- Change in brachial artery flow-mediated vasodilation (FMD) [ Time Frame: Baseline, 12 weeks ]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
- Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT as a measure of vascular inflammation [ Time Frame: Baseline, 12 weeks ]Assessed by FDG-PET/CT scanning
- Rate of change in inflammatory markers of CVD risk [ Time Frame: Baseline, 4 weeks, 12 weeks, 18 weeks ]Linear mixed modelling will be used to estimate rates of change over the 18 weeks of treatment. Inflammatory markers: high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), soluble CD163 (sCD163), D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir

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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 |


Responsible Party: | Priscilla Hsue, MD, Professor in Residence, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT02272946 |
Other Study ID Numbers: |
Canakinumab |
First Posted: | October 23, 2014 Key Record Dates |
Last Update Posted: | November 10, 2021 |
Last Verified: | November 2021 |
Cardiovascular Diseases Inflammation Pathologic Processes |