A Randomised, Double-Blind, Multicenter, Placebo-Controlled Clinical Trial of Colchicine to Reduce Coronary Artery Inflammation in People With HIV. COLCOHIV
The purpose of this study is to evaluate whether colchicine can reduce coronary artery inflammation in people living with HIV and high cardiovascular risk. Participants will be randomized 1:1 to receive either colchicine or placebo for 96 weeks in a double-blind, multicenter clinical trial. Neither participants nor researchers will know which treatment is assigned during the study. The primary endpoint is the change in coronary artery inflammation measured by coronary computed tomography angiography (CCTA) after 96 weeks.
• PWH \> 50 years old
• High cardiovascular risk measured by SCORE-2 \> 5%
• Stable antiretroviral therapy (ART) in the previous six months
• Viral load \< 50 copies/mililiter for at least 1 year. One blip is allowed (Viral load between 20-200 copies/mililiter with a previous and after viral load determinations \< 20 copies per mililiter.
• CD4 cell count \> 350 cells/mm3
• Stable dose of an intermediate or high intensity statin in the previous year (statin dose should not be modified throghout the study unless there is a robust clinical indication). In case the participant does not receive statins, all other hypolipemiants (bempedoic acid, ezetimibe) will need to be at a stable dose as well in the previous year.
• No clinical indication for a change in treatment based on European Society of Cardiology Guidelines
• Written informed consent obtained according to international guidelines and local laws
• Ability to understand the nature of the trial and the trial related procedures and to comply with them