Colchicine to Reduce Coronary Artery Inflammation in People With HIV

NCT07704164 | Recruiting Phase 2

• 2 other identifiers: COLCOHIV2024-520346-39-00
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief 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

HIV Infection; Cardiovascular Diseases (CVD)

Keywords

Coronary artery inflammation; Atherosclerosis; Coronary computed tomography angiography; Fat attenuation index

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 96

Secondary Outcomes (24)

• Changes in coronary plaque volume

  Baseline to Week 96

• Changes in coronary plaque burden

  Baseline to Week 96

• Change in non-calcified plaque volume

  Baseline to Week 96

• Change in mixed plaque volume

  Baseline to Week 96

• Change in calcified plaque volume

  Baseline to Week 96

Other Outcomes (4)

• Sex-related differences in inflammatory patterns and treatment response

  Baseline to Week 96

• CYP2D6 genotype-related differences in treatment response

  Baseline to Week 96

• Major adverse cardiovascular events (MACE)

  Baseline to Week 96

Study Arms (2)

Study Group

EXPERIMENTAL

Colchicine 0.5 mg orally once daily for 96 weeks.

Drug: Colchicine 0.5 mg

Control Group

PLACEBO COMPARATOR

Matching placebo orally once daily for 96 weeks.

Drug: Placebo

Interventions

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.

Study Group

Placebo DRUG

Matching placebo administered orally once daily for 96 weeks.

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Levels of ALT over five times the upper limit of normal OR levels of ALT over three times the upper limit of normal AND bilirrubin levels over one point five times the upper limit of normal
• Participant is receiving drugs that inhibit the CYP3A4 (e.g. Verapamil, Azithromycin, Clarithromycin, protease inhibitors, cobicistat), CYP2D6 or inhibitors of P-glycoprotein (see section 6.3.2 for more information)
• Participant needs treatment with colchicine for any indication
• Participants with highly elevated hsCRP \> 10 mg/dL at screening
• Women of childbearing potential. For this trial, definitions of nonchildbearing potential includes:
• Permanent sterilisation methods including hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
• Postmenopausal state, defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
• Male participants are considered fertile after puberty unless permanently sterile by bilateral orchiectomy. To prevent pregnancies in female partners of male participants, they must agree to use highly effective contraceptive methods or have practiced sexual abstinence during the treatment period and until the end of relevant systemic exposure, defined as 5 half-lives of the IMP (9 days approximately).

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (4)

Hospital Universitario Vall d' Hebron

Barcelona, Spain

RECRUITING

Hospital La Paz

Madrid, 28046, Spain

RECRUITING

Fundación Jiménez Díaz

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario de la Princesa

Madrid, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

HIV Infections; Cardiovascular Diseases; Atherosclerosis

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• José Ignacio Bernardino de la Serna, MD, PhD

  Hospital Universitario La Paz. IdiPAZ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Ignacio Bernardino de la Serna, MD, PhD

CONTACT

(+34) 915683515; Jose.bernardino@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

ES (4)