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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Collaborator: Thai AIDs society
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• PLHIV receiving ART (TDF/FTC/EFV, TDF/FTC+RPV, TDF+3TC+RPV, TDF/3TC/DTG, or ABC/3TC/EFV) for more than 6 months

• hs-CRP >=2 mg/mL

• Agree to participate the study

Exclusion Criteria:

• Those who has contraindication for colchicine

• Those who had history of allergy to colchicine

• Those who was diagnosed with myocardial infarction or ischemic stroke

• Those who was diagnosed with cirrhosis child B or C

• Those who had eGFR <30 ml/min/1.73 m2)

• Those who had HIV viral load more than 40 copies/mL in 6 months before entering the study

• Those who has CD4 less than 300 cells/mm3

• Deny to participate the study