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Low-Dose Colchicine on Surrogate Markers of Cardiovascular Events in PLWH
NCT05168137Phase 4
Key facts
- Status
- Unknown
- Start
- Feb 2020
- Primary completion
- Jun 2022
- Countries
- 1
- Sponsor
- Mahidol University
- Modality
- Nucleic Acid-Directed Small Molecules, Classical Binding Small Molecules, Metabolically Activated Prodrugs
- Drugs
- colchicine
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 4, randomised, double-blind trial in human immunodeficiency virus infection (HIV) comparing Colchicine with Placebo (2 arms). Primary endpoints: High-sensitivity C-reactive protein at 6 months, Interleukin-6 at 6 months and 1 more. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Colchicine
Colchicine 0.6 mg daily
Placebo
Placebo daily
03
Who it enrols
PLWH aged >30 years on stable ART for >=6 months, with suppressed viral load, CD4 >=300, hs-CRP >=2 mg/L, and eGFR >30. Excludes patients with severe kidney/liver disease or history of cardiovascular events.
04
Endpoints
Primary
High-sensitivity C-reactive protein
Interleukin-6
Interleukin-1 receptor antagonist
Secondary
Safety outcomes
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