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Colchicine for Coronary Endothelial Function in HIV
NCT02624180Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2015
- Primary completion
- Aug 2020
- Countries
- 1
- Sponsor
- Johns Hopkins University
- Modality
- Nucleic Acid-Directed Small Molecules, Classical Binding Small Molecules, Metabolically Activated Prodrugs
- Drugs
- colchicine
- Conditions
- Coronary atherosclerosis (CAD)
01
Overview
Phase 2, randomised, double-blind trial in Coronary atherosclerosis (CAD) comparing Colchicine with Placebo (2 arms). Primary endpoint: Coronary Endothelial Function at 8 weeks. Started Nov 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Colchicine
Colchicine 0.6 mg daily
Placebo
Placebo daily
03
Who it enrols
HIV positive adults on stable ART with viral load <100 copies/mL and abnormal coronary endothelial function, without clinical CAD or contraindications to MRI/colchicine.
04
Endpoints
Primary
Coronary Endothelial Function
Secondary
Coronary Endothelial Function
Coronary Artery Cross-sectional Area
High-sensitivity C-reactive Protein
Brachial Flow Mediated Dilatation
Interleukin-6
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