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

Conditions

• Cardiovascular Disease
• HIV

Eligibility Criteria

Sex

ALL

Age

40 Years - 59 Years

Healthy Volunteers

Not accepted

Interventions

• Canakinumab — DRUG
  150mg Canakinumab received subcutaneously
• Placebo — DRUG
  150mg Placebo received subcutaneously

Study Details

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 Dates

Start date

Sep 30, 2015

Status verified

Mar 2023

Primary completion

Feb 28, 2021

Completion

Dec 31, 2021

Study Design

Enrollment

43 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: 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).
• Experimental: Canakinumab
  In Stage II: About 67 subjects will receive 150mg Canakinumab subcutaneous injection.
• Placebo Comparator: Placebo
  In Stage II: About 33 subjects will receive 150mg placebo subcutaneous injection

Primary Outcome Measure

Change in CD4 Count From Baseline to Follow-up [ Time Frame: weeks 4, 8, 12, 18, 24, and 36. ]

Locations (1)

Find similar trials in San Francisco, CA

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