Colchicine to Reduce Coronary Artery Inflammation in People With HIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorInstituto de Investigación Hospital Universitario La Paz
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Colchicine 0.5 mg
- Placebo
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Instituto de Investigación Hospital Universitario La Paz
Lead sponsor
Instituto de Salud Carlos III
Collaborator
Source ClinicalTrials.gov