Randomized Trial of Colchicine to Reduce Coronary Artery Inflammation in People 50 and Older Living With HIV and High Cardiovascular Risk

What this Trial Is About

Researchers are evaluating colchicine, an anti-inflammatory drug, to see if it can reduce coronary artery inflammation in people aged 50 and older living with HIV who have a high risk of cardiovascular disease. This phase 2, randomized, double-blind, placebo-controlled trial addresses the increased cardiovascular risk in people living with HIV despite stable antiretroviral therapy. The study aims to measure changes in coronary artery inflammation over 96 weeks using advanced imaging techniques. Participants are randomly assigned to receive either colchicine 0.5 mg or a matching placebo, taken orally once daily for 96 weeks. The study is conducted across multiple centers and uses coronary computed tomography angiography CCTA and the perivascular fat attenuation index FAI to assess coronary inflammation. Safety and changes in various cardiovascular and inflammatory markers are also monitored throughout the study. During the trial, participants will undergo scheduled imaging scans and blood tests to evaluate coronary plaque characteristics, inflammatory markers, and immune cell changes from baseline to week 96. The primary outcome is the change in coronary artery inflammation. Researchers will also track adverse events and serious adverse events throughout the study period, which lasts approximately two years, to monitor safety and treatment effects.

Colchicine to Reduce Coronary Artery Inflammation in People With HIV