Colchicine to Reduce Coronary Artery Inflammation in People With HIV

ConditionsHIV Infection Cardiovascular Diseases (CVD)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Colchicine 0.5 mg
Drug
Colchicine 0.5 mg administered orally once daily for 96 weeks as an anti-inflammatory treatment to reduce coronary artery inflammation in people living with HIV and high cardiovascular risk.
Placebo
Drug
Matching placebo administered orally once daily for 96 weeks.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Study GroupExperimental treatment 1 intervention

Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Changes in coronary artery inflammation

Percent change from baseline of the mean Fat Attenuation Index (FAI) score for the three main coronary arteries (right coronary artery \[RCA\], left anterior descending artery \[LAD\], and left circumflex artery \[LCX\]). The mean FAI score will be calculated as the average of analyzable FAI scores with valid baseline and post-baseline measurements across the three coronary arteries.

Time frame

Baseline to Week 96

Secondary outcomes

Changes in coronary plaque volume

Change from baseline in total coronary plaque volume assessed by coronary computed tomography angiography (CCTA) at Week 96.

Time frame

Baseline to Week 96

Changes in coronary plaque burden

Change from baseline in coronary plaque burden assessed by coronary computed tomography angiography (CCTA) at Week 96.

Time frame

Baseline to Week 96

Change in non-calcified plaque volume

Change from baseline in non-calcified coronary plaque volume assessed by coronary computed tomography angiography (CCTA) at Week 96.

Time frame

Baseline to Week 96

Change in mixed plaque volume

Change from baseline in mixed coronary plaque volume assessed by coronary computed tomography angiography (CCTA) at Week 96.

Time frame

Baseline to Week 96

Other outcomes

Sex-related differences in inflammatory patterns and treatment response

Difference in the percentage change of Fat Attenuation Index (FAI) between males and females in both treatment groups assessed by coronary computed tomography angiography (CCTA) in week 96.

Time frame

Baseline to Week 96

CYP2D6 genotype-related differences in treatment response

Difference in FAI percentage change according to CYP2D6 metabolizer classification in participants receiving colchicine.

Time frame

Baseline to Week 96

Major adverse cardiovascular events (MACE)

Difference in major adverse cardiovascular events (MACE) between colchicine and placebo groups assessed clinically in week 96.

Time frame

Baseline to Week 96

Cardiovascular risk score

Change from baseline in the CaRi-Heart risk score, including mean absolute change and mean percentage change.

Time frame

Baseline to Week 96

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto de Investigación Hospital Universitario La Paz

Lead sponsor

Instituto de Salud Carlos III

Collaborator

Source ClinicalTrials.gov

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