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Colchicine to Reduce Coronary Artery Inflammation in People With HIV

NCT07704164 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Colchicine 0.5 mg

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.

DRUG

Placebo

Matching placebo administered orally once daily for 96 weeks.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • José Ignacio Bernardino de la Serna, MD, PhD · Hospital Universitario La Paz. IdiPAZ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07704164 on ClinicalTrials.gov