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HIV and Changes in the Gut Microbiome After Changes in Antiretroviral Therapy (ART)

This study is investigating how different HIV medications affect the bacteria, viruses, and other tiny living things that live in our gut, known as the gut microbiome. Our gut health is very important for our overall well-being. People with HIV often have an imbalanced gut microbiome. Researchers want to see what happens to these gut bacteria when someone switches their HIV treatment, both a different type of drug or a different way of taking it. By comparing an individual's gut bacteria before and after a change in treatment, the study hopes to learn more about which treatments might be best for maintaining a healthy gut, ultimately improving the long-term health of people living with HIV.

At a glance

Status
Recruiting
Sponsor
University of Manchester
Enrolment target
15
Start
17 May 2024
Estimated completion
01 May 2025

What is this study about?

Imagine your gut is like a bustling garden, full of tiny plants and creatures – this is your gut microbiome. These tiny residents play a huge role in your health, affecting everything from your digestion to your energy levels. We know that living with HIV can change this delicate balance in the gut.

Doctors use special medicines called antiretroviral therapy (ART) to treat HIV. While ART is very effective at controlling the virus, we don't fully understand how different types of ART might affect this gut garden. Some studies suggest that the gut balance doesn't fully return to normal even with treatment, and different ART medicines might have different effects.

This study aims to get a clearer picture. Instead of looking at large groups of people, researchers will focus on individuals. They'll study someone's gut microbiome before they switch their HIV medication – either to a different type of drug or a different way of taking it. Then, they'll check the gut microbiome again a few weeks after the switch. This 'before and after' comparison in the same person will help them understand what changes might be linked to specific treatments. The hope is that this new understanding could help doctors make more personalised choices about HIV treatment, leading to better long-term health and fewer negative effects from lifelong medication.

Key takeaways

  • This study looks at how HIV medicines affect gut bacteria.
  • Good gut health is important for everyone, especially those with HIV.
  • It could help doctors choose the best HIV treatment for each patient.
  • Participation involves providing two stool samples over a few weeks.
  • You must be planning to change your HIV medication to join.

Who may be eligible?

To join this study, you need to be at least 18 years old and have HIV. You should have been on your current HIV treatment steadily for at least a year. You also need to be planning to change your HIV medication, either switching to a different type of drug or a different way of taking it.

It's important that you are willing to provide stool samples (poo samples) twice during the study. You must also be able to understand the study information and give your written permission to take part.

You cannot join the study if the amount of HIV in your blood (your viral load) is still detectable at more than 50 copies per milliliter. This study is for people whose HIV is well-controlled.

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.

  1. Are you 18 years old or older?
  2. Do you have HIV and is your viral load undetectable (below 50 copies/ml)?
  3. Have you been on your current HIV treatment for at least a year?
  4. Are you planning to change your HIV treatment soon?
  5. Are you happy to provide two stool samples?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be asked to provide two stool (poo) samples. The first sample will be collected before you switch your HIV medication. The second sample will be collected 3 to 8 weeks after you have made your switch. There are no extra doctor's visits required beyond your usual care, nor will you be asked to take any new or different medications as part of this study. The total duration of your active participation, providing the samples, will be between 3 to 8 weeks.

Potential risks and benefits

While there aren't direct health benefits from taking part, your contribution will help doctors understand how different HIV treatments affect gut health, potentially leading to better care for people with HIV in the future. The main involvement is providing stool samples, which is generally considered very low risk. You are always free to change your mind and withdraw from the study at any time, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Manchester University NHS Foundation Trust
    Verified postcode
    Manchester, United Kingdom· Recruiting

Common questions

What is the 'gut microbiome'?

It's the collection of all the tiny living things, like bacteria and viruses, that live in your digestive system and help keep you healthy.

Why is gut health important for people with HIV?

The gut microbiome can be different in people with HIV, and keeping it balanced is important for overall health and well-being.

Will this study change my current HIV treatment?

No, this study is for people who are already planning to switch their HIV treatment as part of their regular care. The study doesn't influence that decision.

What do I have to do if I join?

You'll provide two stool samples: one before you change your HIV medicine and one about 3-8 weeks after the change. That's all.

Will I get any results from my samples?

The study aims to understand general patterns. Individual results usually aren't shared, but the overall findings will help improve care.

How to find out more

Gabriella LA Lindergard, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "HIV and Changes in the Gut Microbiome After Changes in Antir…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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