Could a common gout pill protect hearts in HIV?
NCT ID NCT07704164
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fundación Jiménez Díaz
NOT_YET_RECRUITINGMadrid, Spain
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Hospital La Paz
RECRUITINGMadrid, 28046, Spain
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Hospital Universitario Vall d' Hebron
RECRUITINGBarcelona, Spain
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Hospital Universitario de la Princesa
NOT_YET_RECRUITINGMadrid, Spain
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