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NCT02272946 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Priscilla Hsue, MD.

Completed
Registry status
Phase 2
Development phase
43
Enrollment target

NCT02272946: Completed Phase 2 study, sponsored by Priscilla Hsue, MD.

NCT02272946 is a Phase 2 study that has completed, run by Priscilla Hsue, MD. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02272946, a Phase 2 study, has completed, sponsored by Priscilla Hsue, MD.

COMPLETED
Registry status
Phase 2
Development phase
43 participants
Enrollment target

Study 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.

Primary Outcome

Change in CD4 count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.

Interventions

  • DRUG Placebo
  • DRUG Canakinumab

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2015-09
Est. Completion 2021-12
Phase Phase 2
Priscilla Hsue, MD

3 total trials

What the finished NCT02272946 record still lists

NCT02272946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02272946 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02272946 about?

NCT02272946 is a clinical study titled "Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk". 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 cana...

What is the current status of trial NCT02272946?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2015-09. Estimated completion is 2021-12.

What interventions are being tested in trial NCT02272946?

The interventions under investigation include: Placebo (DRUG), Canakinumab (DRUG).

Who is sponsoring clinical trial NCT02272946?

This trial is sponsored by Priscilla Hsue, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02272946's enrollment target sits among peer trials

43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02272946, the US trial registry maintained by the National Library of Medicine. NCT02272946 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.