Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Phase IV comparative, randomized, open-label pilot study to evaluate the efficacy and safety of a rilpivirine-based antiretroviral treatment regimen in HIV-infected patients with metabolic liver disease who maintain undetectable HIV viral load

This research is a pilot study, which means it's a small-scale trial to see if a new approach is promising. It focuses on people living with HIV who also have a condition called metabolic liver disease. For those living with HIV, keeping the virus under control is key. This study compares a specific HIV medicine, Juluca, which contains rilpivirine, with other common HIV treatments. The main goal is to see if taking a Juluca-based treatment can prevent or even reduce changes in liver health over 18 months, as measured by special non-invasive liver tests. Participants will be randomly assigned to receive either the new treatment combination or existing ones, and doctors will carefully monitor their liver health and HIV levels.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacion Seimc Gesida, Fundacion Seimc Gesida

Enrolment target

Start

29 Mar 2023

Metabolic liver disease in HIV-infected people

What is this study about?

This study is a research project designed for people living with HIV who also have a type of liver problem called metabolic liver disease. Metabolic liver disease means there are issues with how your body processes energy and fat, which can affect your liver over time. For people with HIV, managing both conditions effectively is really important for good health.

The main aim of this study is to look at a particular HIV treatment called a rilpivirine-based regimen, which includes medicines like Juluca. Doctors want to see if this treatment is better than other standard HIV medications at improving or preventing the worsening of liver problems. They will be comparing these treatments in a careful and structured way.

Over 18 months, friendly medical staff will monitor participants' liver health using special, gentle tests that don't involve needles or surgery. These tests help doctors understand how stiff or scarred the liver might be. They also want to make sure that people participating continue to have their HIV under control, meaning the amount of virus in their blood stays very low.

Key takeaways

Study for people with HIV and metabolic liver disease.
Compares a new HIV treatment combination (rilpivirine-based) to standard ones.
Aims to see if the new treatment helps liver health over 18 months.
Uses gentle, non-invasive tests to check the liver.
Ensures HIV remains under control (undetectable viral load).

Who may be eligible?

To be able to join this study, you must be 18 years old or older. The study is open to both men and women.

Crucially, you must be living with HIV and also have metabolic liver disease. This means the study is specifically for people who are managing both of these health conditions.

You will also need to already be on HIV treatment and currently have your HIV viral load undetectable. This means your current HIV medication is working well to keep the virus levels in your body very low.

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.

Am I 18 years old or older?
Do I have HIV?
Do I also have metabolic liver disease?
Is my HIV viral load currently undetectable with my current treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to receive a specific HIV treatment. This could be a new combination of medicines or one of the existing standard treatments. You'll take these medicines as tablets. The study will last for 18 months, during which time you will have regular visits to the clinic.

During these visits, healthcare professionals will perform non-invasive tests to check your liver health. These are simple tests, like scans or blood tests, to see how your liver is doing. They will also monitor your HIV levels to make sure your treatment is still effective. There will be ongoing follow-up to ensure your safety and track your progress throughout the study duration.

Potential risks and benefits

Taking part in any study has possible benefits and risks. You might benefit from closer monitoring of your health and access to new treatments that could improve your liver condition while keeping your HIV under control. However, there might be side effects from the medications, or the treatments might not work as well for you as hoped. You are always free to leave 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 metabolic liver disease?

It's a liver condition linked to problems with how your body processes food and energy, which can affect liver health over time.

What does 'undetectable HIV viral load' mean?

It means your HIV medication is working very well, and the amount of HIV virus in your blood is so low it can't be measured by standard tests.

What are 'non-invasive tests' for the liver?

These are gentle tests that check your liver health without needing any surgery or injections, like special scans or blood tests.

Will I know which treatment I'm receiving?

Yes, this is an 'open-label' study, meaning both you and your doctor will know which medication you are taking.

How long will I be in the study?

The study will last for 18 months, with regular check-ups during that time.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.