Study on Colchicine to Reduce Heart Artery Inflammation in HIV Patients Over 50 with High Cardiovascular Risk

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What is this study about?

This clinical trial is focused on studying the effects of the medication colchicine in people living with HIV who are at high risk for heart disease. The study aims to see if colchicine can help reduce inflammation in the coronary arteries, which are the blood vessels that supply the heart. Inflammation in these arteries can increase the risk of heart problems, especially in individuals with HIV who are over 50 years old and have a high cardiovascular risk.

Participants in the study will be randomly assigned to receive either colchicine or a placebo. The trial will last for 96 weeks, during which time the effects of the treatment on coronary artery inflammation will be monitored. The study will also look at changes in heart plaque, which is a buildup of substances in the arteries, and other markers of inflammation in the blood. These assessments will help determine if colchicine can effectively reduce heart-related risks in the study participants.

The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving colchicine or the placebo until the study is completed. This approach helps ensure that the results are unbiased. The ultimate goal is to understand whether colchicine can be a beneficial treatment for reducing heart disease risk in people with HIV, potentially leading to better health outcomes for this population.

1 joining the trial

Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive the medication colchicine, and the other group will receive a placebo, which looks like the medication but does not contain the active ingredient.

The trial is designed to be double-blind, meaning neither you nor the researchers will know which group you are in. This helps ensure the results are unbiased.

2 medication administration

If you are in the colchicine group, you will take COLCHICINA SEID 0.5 mg tablets by mouth. The dosage is one tablet daily.

The duration of the medication administration is 96 weeks.

3 regular check-ups

Throughout the trial, you will have regular check-ups to monitor your health and the effects of the medication.

These check-ups will include assessments of your heart health and blood tests to measure inflammation markers.

4 end of trial assessments

At the end of the 96-week period, you will undergo final assessments to evaluate changes in your heart health.

These assessments will help determine the effectiveness of colchicine in reducing coronary artery inflammation.

Who Can Join the Study?

Must be a person living with HIV and over 50 years old.
Must have a high cardiovascular risk, which means a higher chance of heart problems, measured by a score called SCORE-2 greater than 5%.
Must have been on a stable antiretroviral therapy (ART) for the past six months. ART is a treatment for HIV.
Must have a viral load (amount of HIV in the blood) of less than 50 copies per milliliter for at least one year. A single temporary increase (called a “blip”) is allowed if it stays between 20-200 copies per milliliter, with tests before and after showing less than 20 copies per milliliter.
Must have a CD4 cell count greater than 350 cells per cubic millimeter. CD4 cells are a type of white blood cell important for the immune system.
Must have been on a stable dose of an intermediate or high-intensity statin for the past year. Statins are medications that help lower cholesterol. If not on statins, other cholesterol-lowering medications like bempedoic acid or ezetimibe must also be at a stable dose for the past year.
There should be no medical reason to change the current treatment based on European Society of Cardiology Guidelines.
Must provide written informed consent, which means agreeing to participate in the study after understanding what it involves, according to international guidelines and local laws.
Must be able to understand the nature of the trial and the procedures involved, and be able to follow them.

Who Cannot Join the Study?

Patients who are not at high cardiovascular risk cannot participate. This means if your heart and blood vessels are not at a high risk of disease, you cannot join.
Patients who are not living with HIV cannot participate. HIV is a virus that affects the immune system.
Patients under the age of 50 cannot participate. Only those who are 50 years or older can join.
Patients who are part of a vulnerable population cannot participate. This means if you are in a group that needs special protection, you cannot join.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Htwpybsc Ujrnosotaxhye Do Lc Pssrquyy	Madrid	Spain
Flmsnaqod Pcys Ld Iafvdoqiguavx Bmwlddmbk Dcz Htqdsvio Udijlnfrgzszd Lb Pfh	Madrid	Spain
Hxafeiai Vjzn dljybwpx	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.09.2025

Trial locations

Investigated drugs:

Colchicine

Colchicine is a medication that is being tested in this clinical trial to see if it can help reduce inflammation in the coronary arteries of people living with HIV. Inflammation in the coronary arteries can lead to heart problems, so the goal of using colchicine is to lower this inflammation and potentially reduce the risk of heart disease. Colchicine is already used for other conditions that involve inflammation, and this trial is exploring its benefits for heart health in people with HIV who are over 50 years old and have a high risk of cardiovascular issues.

Investigated diseases:

HIV infection

Human Immunodeficiency Virus (HIV) Infection – HIV infection is a condition caused by the human immunodeficiency virus, which attacks the body’s immune system, specifically the CD4 cells (T cells). Over time, HIV can destroy so many of these cells that the body can’t fight off infections and disease. The virus progresses through several stages, starting with acute infection, followed by clinical latency, and eventually leading to acquired immunodeficiency syndrome (AIDS) if untreated. During the acute phase, individuals may experience flu-like symptoms, while the clinical latency stage may have no symptoms. As the disease progresses, the immune system becomes severely compromised, making the body more susceptible to opportunistic infections and certain cancers. The progression rate can vary significantly among individuals.

Trial ID:

2024-520346-39-00

Protocol code:

COLCOHIV

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Colchicine to Reduce Heart Artery Inflammation in HIV Patients Over 50 with High Cardiovascular Risk

What is this study about?

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