San Francisco General Hospital
San Francisco, California, 94110, United States
NCT Number: NCT02272946
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.
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Notify Me40 year–59 year
All sexes
Interventional
Phase 2
San Francisco, California, 94110, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
150mg Canakinumab received subcutaneously
Other names: IL--1β
150mg Placebo received subcutaneously
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.
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.
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.
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.
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.
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.
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.
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
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
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.
Time frame: Baseline, 4 weeks, 12 weeks, and week 18
SAA will be assessed from baseline to weeks 4, 12, and 18.
Time frame: Baseline, 4 weeks, 12 weeks, and week 18
TNFa will be assessed from baseline to weeks 4, 12, and 18.
Priscilla Hsue, MD
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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