Phase 2 N=43 Randomized Double-blind Treatment

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

HIV · Cardiovascular Disease

Bottom Line

View on ClinicalTrials.gov: NCT02272946 ↗

Enrolled (actual)

Serious AEs

4.7%

Results posted

Apr 2023

Primary outcome: Primary: Change in CD4 Count From Baseline to Follow-up — -0.085; -0.024; -0.020; -0.090 log cells per mm^3

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Canakinumab (Drug); Placebo (Drug)
Age: Adult · 40+ yrs
Sex: All
Sponsor: Priscilla Hsue, MD
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in CD4 Count From Baseline to Follow-up	-0.085; -0.024; -0.020; -0.090; 0.004; -0.015	—
PRIMARY Change in CD8 Count From Baseline to Follow-up	-0.101; -0.039; 0.006; -0.103; -0.069; -0.040	—
PRIMARY Change in Absolute Neutrophil Count From Baseline to Follow-up	-0.157; -0.149; -0.048; -0.137; -0.015; 0.044	—
PRIMARY Change in Platelet Count From Baseline to Follow-up	-0.098; -0.079; 0.026; -0.029; -0.032; 0.007	—
PRIMARY Change in Creatinine Count From Baseline to Follow-up	-0.017; 0.032; -0.011; -0.001; 0.014; -0.012	—
PRIMARY Change in AST From Baseline to Follow-up	0.032; 0.025; -0.103; -0.019; 0.001; 0.055	—
PRIMARY Change in ALT From Baseline to Follow-up	0.100; 0.079; -0.024; -0.123; 0.046; 0.116	—
SECONDARY Flow-Mediated Dilation (FMD)	3; 3; 3; 4; 4; 4	—
SECONDARY Arterial Inflammation Measured at Baseline and Follow-up at Week 12	3.27; 3.18; 3.85; 2.97; 3.21; 4.01	—
SECONDARY D-Dimer	548.3; 2121.89; 1917.03; 499.7; 2042.96; 2080.01	—
SECONDARY Human Serum Amyloid A (SAA)	479058.3; 513209.75; 310588.7; 20045206; 844889.8; 1968440.05	—
SECONDARY Tumor Necrosis Factor Alpha (TNFa)	1.69; 1.24; 1.47; 1.34; 1.18; 1.4	—

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 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.

Eligibility Criteria

Inclusion Criteria

HIV infection,
Age ≥ 40 years 400 mg/dL
History of hypersensitivity to study drug
History of EBV-related lymphoproliferative disorders
Active or untreated latent TB infection

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02272946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.