Colchicine to Reduce Coronary Artery Inflammation in People With HIV (NCT07704164) | Clinical Trial Compass
RecruitingPhase 2
Colchicine to Reduce Coronary Artery Inflammation in People With HIV
Spain90 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Severe Heart failure defined as LVEF \< 35%.
* Previous MI, stroke or coronary by-pass surgery
* History of non-cutaneus malignancy prior to enrollment
* History of inflammatory bowel disease or chronic diarrhoea
* Renal dysfunctions defined as eGFR \< 50 ml/min or serum creatinine levels \> 1.7 mg/dL
* Severe hepatic impairments defined as a Child-Pugh category C
* Participants with stomach ulcers or gastrointestinal bleeding
* Lev…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial, which means it's still in relatively early testing — what does that tell us about how much is already known about colchicine's safety and benefit specifically for people with HIV and heart inflammation?
2The trial is measuring changes in coronary artery inflammation as the main outcome — how would my own level of coronary artery inflammation be assessed before and during the study, and is that something I'd benefit from knowing regardless of whether I join?
3Colchicine is already used for other conditions like gout and pericarditis — does my current HIV medication regimen have any known interactions with colchicine that could make this trial riskier for me?
4Given that people with HIV already have a higher risk of cardiovascular disease, would you recommend I focus on standard proven treatments for heart health first, or does this trial seem like a reasonable path to explore alongside those?
5What would my time commitment look like if I joined — how many visits, tests, or check-ins would be involved, and are there any monitoring requirements I should think through before deciding?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in coronary artery inflammation
Timeframe: Baseline to Week 96
Trial details
NCT IDNCT07704164
SponsorInstituto de Investigación Hospital Universitario La Paz