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Clinical trial of colchicine to reduce coronary artery inflammation in people with HIV.
EU CTIS ID: 2024-520346-39-00
What this study is testing
To assess the impact of colchicine versus placebo in reducing coronary artery inflammation in PWH over 50 years and high cardiovascular risk after 96 weeks
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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.
You likely can't join if
- Severe Heart failure defined as LVEF < 35%.
- 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
- 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.
- Participant needs treatment with colchicine for any indication
See the full eligibility criteria
Who can 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.
- 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
What rules you out
- Severe Heart failure defined as LVEF < 35%.
- 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
- 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.
- Participant needs treatment with colchicine for any indication
- Participants with stomach ulcers or gastrointestinal bleeding
- Participants with highly elevated hsCRP > 10 mg/dL at screening
- Women of childbearing potential. - 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
- Previous MI, stroke or coronary by-pass surgery
- History of non-cutaneus malignancy prior to enrollment
- History of inflammatory bowel disease or chronic diarrhoea
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.