HIV InfectionPhase 2COLCOHIVNCT07704164
Colchicine to Reduce Coronary Artery Inflammation in People With HIV
A Phase 2 study testing Colchicine 0.5 mg in people with HIV Infection and Cardiovascular Diseases (CVD), run by Instituto de Investigación Hospital Universitario La Paz at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV Infection, Cardiovascular Diseases (CVD)
- What is being tested?
- Colchicine 0.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesSpain
- Study dates
- Jun 2026to Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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).
- Known hypersensitivity to the active substances or any of the excipients
- Known iodine contrast allergy with prior history of anaphylaxis
- Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario Vall d' Hebron
Barcelona
Alfonso Curran Fábregas, MD.
- Recruiting
Hospital La Paz
Madrid, 28046
Jose Ignacio Bernardino de la Serna, MD.
- Not yet recruiting
Fundación Jiménez Díaz
Madrid
Alfonso Cabello Uceda, MD.
- Not yet recruiting
Hospital Universitario de la Princesa
Madrid
Lucio García Fraile, MD.
About this study
Official title: A Randomised, Double-Blind, Multicenter, Placebo-Controlled Clinical Trial of Colchicine to Reduce Coronary Artery Inflammation in People With HIV. COLCOHIV
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.
Read the detailed description
Despite advances in antiretroviral therapy, people living with HIV (PWH) have an increased risk of cardiovascular disease compared with the general population. Persistent inflammation and immune activation are considered important contributors to accelerated atherosclerosis and coronary artery disease in this population. Coronary inflammation is associated with cardiovascular risk, but strategies targeting this mechanism in PWH remain limited.
Colchicine is an anti-inflammatory drug that has demonstrated cardiovascular benefits in patients with coronary artery disease by reducing inflammatory pathways involved in atherosclerosis. However, the effect of colchicine on coronary artery inflammation in PWH has not been previously evaluated. The hypothesis of this study is that colchicine may reduce coronary artery inflammation in PWH with high cardiovascular risk.
This phase II, randomized, double-blind, multicenter, placebo-controlled trial will include approximately 90 participants who will receive colchicine or placebo for 96 weeks. Changes in coronary artery inflammation will be assessed using coronary computed tomography angiography (CCTA) and the perivascular fat attenuation index (FAI), a non-invasive imaging biomarker of vascular inflammation. The study will also evaluate safety and changes in cardiovascular and inflammatory markers during follow-up.
- Conditions
- HIV Infection, Cardiovascular Diseases (CVD)
- Being tested
- Colchicine 0.5 mg, Placebo
- Keywords
- Coronary artery inflammation, Atherosclerosis, Coronary computed tomography angiography, Fat attenuation index
- Medical subject headings
- HIV Infections, Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 mgDrug
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.
PlaceboDrug
Matching placebo administered orally once daily for 96 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Colchicine 0.5 mg orally once daily for 96 weeks. Receives: Drug: Colchicine 0.5 mg |
| Control Group | Placebo comparator | Matching placebo orally once daily for 96 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 96
Secondary outcomes (24)
Changes in coronary plaque volume
Change from baseline in total coronary plaque volume assessed by coronary computed tomography angiography (CCTA) at Week 96.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 96
Change in calcified plaque volume
Change from baseline in calcified coronary plaque volume assessed by coronary computed tomography angiography (CCTA) at Week 96.
Measured: Baseline to Week 96
Change in prevalence of positive remodeling plaques
Change from baseline in the percentage of coronary plaques presenting positive remodeling assessed by coronary computed tomography angiography (CCTA) at Week 96.
Measured: Baseline to Week 96
Change in prevalence of spotty calcium plaques
Change from baseline in the percentage of coronary plaques presenting spotty calcium assessed by coronary computed tomography angiography (CCTA) at Week 96.
Measured: Baseline to Week 96
Change in prevalence of napkin-ring sign plaques
Change from baseline in the percentage of coronary plaques presenting a napkin-ring sign assessed by coronary computed tomography angiography (CCTA) at Week 96.
Measured: Baseline to Week 96
Change in prevalence of low attenuation plaques
Change from baseline in the percentage of coronary plaques presenting low attenuation characteristics assessed by coronary computed tomography angiography (CCTA) at Week 96.
Measured: Baseline to Week 96
Change in serum hsCRP concentration
Change from baseline in serum high-sensitivity C-reactive protein (hsCRP) concentration at Week 96.
Measured: Baseline to Week 96
Change in serum IL-6 concentration
Change from baseline in serum interleukin-6 (IL-6) concentration at Week 96.
Measured: Baseline to Week 96
Change in serum IL-1β concentration
Change from baseline in serum interleukin-1 beta (IL-1β) concentration at Week 96.
Measured: Baseline to Week 96
Change in serum IL-18 concentration
Change from baseline in serum interleukin-18 (IL-18) concentration at Week 96.
Measured: Baseline to Week 96
Change in serum SuPAR concentration
Change from baseline in soluble urokinase plasminogen activator receptor (SuPAR) concentration at Week 96.
Measured: Baseline to Week 96
Change in extracellular vesicle NLRP3 levels
Change from baseline in NLRP3 levels in extracellular vesicles at Week 96.
Measured: Baseline to Week 96
Change in extracellular vesicle ASC levels
Change from baseline in ASC levels in extracellular vesicles at Week 96.
Measured: Baseline to Week 96
Change in extracellular vesicle Caspase-1 levels
Change from baseline in Caspase-1 levels in extracellular vesicles at Week 96.
Measured: Baseline to Week 96
Change in classical monocyte proportion
Change from baseline in the proportion of classical monocytes (CD14++CD16-) at Week 96.
Measured: Baseline to Week 96
Change in intermediate monocyte proportion
Change from baseline in the proportion of intermediate monocytes (CD14+CD16+) at Week 96.
Measured: Baseline to Week 96
Change in non-classical monocyte proportion
Change from baseline in the proportion of non-classical monocytes (CD14++CD16++) at Week 96.
Measured: Baseline to Week 96
Changes in leukocyte count
Percentage change of leukocyte count in week 96
Measured: Baseline to Week 96
Changes in arterial inflammation in individual coronary vessels measured by Fat Attenuation Index (FAI)
Change from baseline in FAI and FAI score, including mean absolute change and mean percent change, assessed in individual coronary vessels (right coronary artery [RCA], left anterior descending artery [LAD], and left circumflex artery [LCX]).
Measured: Baseline to Week 96
Mean arterial inflammation across analyzable coronary vessels measured by Fat Attenuation Index (FAI)
Mean absolute change from baseline in mean FAI and FAI score calculated as the average of analyzable coronary vessels with valid baseline and post-baseline measurements.
Measured: Baseline to Week 96
Adverse events and serious adverse events
Incidence of solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs) during the study.
Measured: Over the whole period of patient study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- José Ignacio Bernardino de la Serna, MD, PhD, Principal investigator, Hospital Universitario La Paz. IdiPAZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704164
- Sponsor's protocol ID
- COLCOHIV
- Other IDs
- 2024-520346-39-00
- Acronym
- COLCOHIV
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Multicenter, Placebo-Controlled Clinical Trial of Colchicine to Reduce Coronary Artery Inflammation in People With HIV. COLCOHIV
- ClinicalTrials.gov ID
- NCT07704164
- Acronym / sponsor ID
- COLCOHIV / COLCOHIV
- Conditions
- HIV Infection, Cardiovascular Diseases (CVD)
- Keywords
- Coronary artery inflammation, Atherosclerosis, Coronary computed tomography angiography, Fat attenuation index
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite advances in antiretroviral therapy, people living with HIV (PWH) have an increased risk of cardiovascular disease compared with the general population. Persistent inflammation and immune activation are considered important contributors to accelerated atherosclerosis and coronary artery disease in this population. Coronary inflammation is associated with cardiovascular risk, but strategies targeting this mechanism in PWH remain limited.
Colchicine is an anti-inflammatory drug that has demonstrated cardiovascular benefits in patients with coronary artery disease by reducing inflammatory pathways involved in atherosclerosis. However, the effect of colchicine on coronary artery inflammation in PWH has not been previously evaluated. The hypothesis of this study is that colchicine may reduce coronary artery inflammation in PWH with high cardiovascular risk.
This phase II, randomized, double-blind, multicenter, placebo-controlled trial will include approximately 90 participants who will receive colchicine or placebo for 96 weeks. Changes in coronary artery inflammation will be assessed using coronary computed tomography angiography (CCTA) and the perivascular fat attenuation index (FAI), a non-invasive imaging biomarker of vascular inflammation. The study will also evaluate safety and changes in cardiovascular and inflammatory markers during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Colchicine 0.5 mgColchicine 0.5 mg orally once daily for 96 weeks. |
| Control Group | Placebo comparator | Drug: PlaceboMatching placebo orally once daily for 96 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 mgColchicine 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 | Study Group |
| PlaceboMatching placebo administered orally once daily for 96 weeks. | Drug | Control Group |
Primary outcome
Changes in coronary artery inflammation
Time frame: Baseline to Week 96
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.
24 secondary outcomes
Changes in coronary plaque volume
Time frame: Baseline to Week 96
Changes in coronary plaque burden
Time frame: Baseline to Week 96
Change in non-calcified plaque volume
Time frame: Baseline to Week 96
Change in mixed plaque volume
Time frame: Baseline to Week 96
Change in calcified plaque volume
Time frame: Baseline to Week 96
Change in prevalence of positive remodeling plaques
Time frame: Baseline to Week 96
Change in prevalence of spotty calcium plaques
Time frame: Baseline to Week 96
Change in prevalence of napkin-ring sign plaques
Time frame: Baseline to Week 96
Change in prevalence of low attenuation plaques
Time frame: Baseline to Week 96
Change in serum hsCRP concentration
Time frame: Baseline to Week 96
Change in serum IL-6 concentration
Time frame: Baseline to Week 96
Change in serum IL-1β concentration
Time frame: Baseline to Week 96
Change in serum IL-18 concentration
Time frame: Baseline to Week 96
Change in serum SuPAR concentration
Time frame: Baseline to Week 96
Change in extracellular vesicle NLRP3 levels
Time frame: Baseline to Week 96
Change in extracellular vesicle ASC levels
Time frame: Baseline to Week 96
Change in extracellular vesicle Caspase-1 levels
Time frame: Baseline to Week 96
Change in classical monocyte proportion
Time frame: Baseline to Week 96
Change in intermediate monocyte proportion
Time frame: Baseline to Week 96
Change in non-classical monocyte proportion
Time frame: Baseline to Week 96
Changes in leukocyte count
Time frame: Baseline to Week 96
Changes in arterial inflammation in individual coronary vessels measured by Fat Attenuation Index (FAI)
Time frame: Baseline to Week 96
Mean arterial inflammation across analyzable coronary vessels measured by Fat Attenuation Index (FAI)
Time frame: Baseline to Week 96
Adverse events and serious adverse events
Time frame: Over the whole period of patient study participation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José Ignacio Bernardino de la Serna, MD, PhD principal investigator
Hospital Universitario La Paz. IdiPAZ
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine 0.5 mg in people with HIV Infection and Cardiovascular Diseases (CVD), run by Instituto de Investigación Hospital Universitario La Paz at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Ignacio Bernardino de la Serna, MD, PhD ((+34) 915683515, Jose.bernardino@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in coronary artery inflammation (time frame: Baseline to Week 96). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.