Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV, Cardiovascular Disease

In brief

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 treated and suppressed HIV infected individuals This study will assess the safety and effects of canakinumab on endothelial function (assessed by flow-mediated vasodilation \[FMD\] of the brachial artery), vascular inflammation (assessed by FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk (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. 10 individuals will receive a single dose of 150mg canakinumab with follow-up for 12 weeks. In the second part of the study, 100 participants will be randomized (2:1 - canakinumab to placebo) and will be followed by for 36 weeks.

Key facts

Study ID

NCT02272946

Run by

Priscilla Hsue, MD

People needed

43

Starts

2015-09-01

Expected to finish

2021-12-01

Last updated by the study team

2023-04-20

Who can join

Age: 40 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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