Could a common gout pill protect hearts in HIV?

NCT ID NCT07704164

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This trial tests whether colchicine, an anti-inflammatory drug used for gout, can reduce inflammation in the coronary arteries of people with HIV who have high cardiovascular risk. Participants take either colchicine or a placebo daily for 96 weeks, and changes in artery inflammation are measured with a CT scan. The goal is to see if this approach could lower the risk of heart disease in this population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
colchicine 0.5 mg tablet taken once daily
What this could lead to
If it works, this could point toward a way to lower heart attack risk in people with HIV by reducing artery inflammation.
What could go wrong
This is a small, early-phase trial (90 people) testing a surrogate marker, not heart attacks directly. Colchicine can cause gastrointestinal side effects and may not reduce inflammation enough to matter.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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). * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fundación Jiménez Díaz

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Vall d' Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario de la Princesa

    NOT_YET_RECRUITING

    Madrid, Spain

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