AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomised, double-blind, multicenter, placebo-controlled clinical trial of colchicine to reduce coronary artery inflammation in people with HIV. COLCOHIV

This study, called COLCOHIV, is investigating a drug called colchicine to see if it can help reduce inflammation in the arteries around the heart. It's specifically for people living with HIV who are at a higher risk of developing heart conditions. Participants will either receive colchicine or a dummy pill, known as a placebo, without knowing which one they are taking. Doctors will carefully measure changes in heart artery inflammation using special scans to see if colchicine makes a difference. The aim is to find better ways to protect the hearts of people with HIV.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Enrolment target

104

Start

25 Apr 2025

High cardiovascular risk in HIV patients

What is this study about?

This study is called COLCOHIV, and it's looking into heart health for people living with HIV. We know that people with HIV can sometimes be at a higher risk of developing heart problems, partly due to inflammation in their arteries. This study wants to see if a drug called colchicine can help reduce this inflammation. Colchicine is already used for other conditions, and doctors believe it might also be helpful for the heart.

To find this out, the study will compare colchicine to a "dummy" pill, called a placebo. This is a very common way to test new treatments, as it helps doctors understand if any changes are due to the drug itself or something else. Participants won't know if they're getting the actual drug or the placebo, and neither will their doctors. This helps make the study as fair and accurate as possible.

The main goal is to measure changes in inflammation in the heart's arteries. Doctors will use special scans to check these arteries at the beginning and then again later in the study. They will also look at how the shape of the arteries changes and measure certain markers in the blood that indicate inflammation. All of this helps researchers understand if colchicine can make a real difference in protecting the hearts of people with HIV.

Key takeaways

This study is exploring if colchicine can reduce heart inflammation in people with HIV.
It compares colchicine to a dummy pill (placebo) to ensure fair results.
Participants will have regular health checks, blood tests, and heart scans.
The study aims to improve heart health for people living with HIV.
Participation involves about two years of follow-up.

Who may be eligible?

This study is open to both men and women aged 18 and older. You would need to be living with HIV and have a higher risk of heart and blood vessel problems. Your doctor would help determine if you fit this description based on your health history.

To join, you wouldn't be allowed to have certain existing severe heart conditions or other serious illnesses that might interfere with the study or make taking the medication unsafe. The study team will carefully review your medical records to ensure it's a safe and appropriate option for you.

It's important that you are able to attend regular appointments and follow the study instructions for the entire duration if you decide to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you living with HIV?
Has your doctor told you that you are at a higher risk of heart problems?
Are you willing and able to attend regular study appointments and take daily medication for about two years?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it will involve taking either the study drug (colchicine) or a dummy pill every day. You won't know which one you are taking, and neither will your local study doctor. You'll have several visits to the clinic over a period of time, where doctors will closely monitor your health.

These visits will likely include blood tests to check various markers of inflammation and your general health. You'll also have special heart scans, called CCTA scans, at the beginning of the study and again later on, typically after about 96 weeks (around 1 year and 10 months). These scans help doctors see changes in your heart's arteries.

Throughout the study, the medical team will keep a close eye on any side effects you might experience, both minor and more serious ones. The total duration of your active participation, including follow-up, is expected to be around 96 weeks, or roughly two years.

Potential risks and benefits

Participating in research studies comes with potential benefits and risks. You might benefit from closer medical monitoring and potentially from the study drug if it proves effective, though this is not guaranteed as it's an exploratory trial. There's also the satisfaction of contributing to medical knowledge that could help others. Potential risks include side effects from the medication (like stomach upset) or discomfort from blood tests and scans. The research team will explain all known side effects. Remember, taking part is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is colchicine?

Colchicine is a medicine that reduces inflammation. It's often used for conditions like gout and is being tested here to see if it helps with heart inflammation in people with HIV.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the study drug but contains no active medicine. It helps researchers fairly compare how well the real drug works.

Why focus on people with HIV?

People with HIV can have a higher risk of heart problems due to inflammation. This study aims to find specific treatments to improve their heart health.

What are heart artery scans (CCTA)?

CCTA stands for CT Coronary Angiography. It's a special type of X-ray scan that takes detailed pictures of your heart's arteries to look for inflammation or blockages.

How long does the study last?

If you join, your active participation in the study, including follow-up appointments and taking medication, is expected to last for about 96 weeks, which is almost two years.