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New treatment option for HIV Infection
Official title Colchicine to Reduce Coronary Artery Inflammation in People With HIV
ClinicalTrials.gov ID: NCT07704164
What this study is testing
What is Colchicine 0.5 mg?
Colchicine 0.5 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hiv infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
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...
- CD4 cell count \> 350 cells/mm3
You likely can't join 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 \ 1.7 mg/dL
- Severe hepatic impairments defined as a Child-Pugh category C
See the full eligibility 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...
- 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
- 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 \ 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
- Madrid, Spain
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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain; Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.