NCT02272946

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Priscilla Hsue, MD · Academic / Other
• Sex: All
• Age: 40 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Canakinumab	150mg Canakinumab received subcutaneously
DRUG	Placebo	150mg Placebo received subcutaneously

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-02-01
• Completion: 2021-12-01
• First posted: 2014-10-23
• Last updated: 2023-04-20
• Results posted: 2023-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study