drugset / Trial / NCT05168137

Efficacy and Safety of Low-Dose Colchicine on Surrogate Markers of Cardiovascular Events in People Living With HIV Receiving Antiretroviral Therapy

NCT05168137

Phase 4 Unknown 84 enrolled Mahidol University Thai AIDs society · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

In a double-blind, randomized controlled trial, we assigned PLWH receiving ART without a history of cardiovascular events to received colchicine 0.6 mg once daily or placebo. The primary endpoint was the mean difference of hs-CRP, IL-6, and IL-1 Ra levels at three and six months. The secondary endpoint was to access safety outcomes.

Timeline

Start
2020-02-01
Primary completion
2022-06-30
Completion
2022-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Colchicine Small molecule 0.6 mg Oral