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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 is a Phase 2 study that has completed, run by Priscilla Hsue, MD. The registered enrollment target is 43 participants.
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.
Interventions
- DRUG Placebo
- DRUG Canakinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-09 |
| Est. Completion | 2021-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02272946
The ClinicalTrials.gov registry entry for NCT02272946 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Priscilla Hsue, MD, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02272946 reports 0 study locations.
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.
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