Not yet recruitingOBSERVATIONAL

Tenofovir Exposures in Advanced Kidney Disease Study

This research study aims to understand how a specific HIV medication, called Tenofovir Alafenamide Fumarate (TAF), works in the bodies of people living with HIV who also have moderate to severe kidney disease. TAF is a part of many HIV treatment regimens. The study will involve taking several blood samples over a 24-hour period from participants who are already taking this medication. By doing this, scientists hope to learn how the body processes TAF and another drug called emtricitabine when kidneys aren't working at their best. This information could help doctors ensure people with kidney problems get the right dose of their HIV medicines in the future.

At a glance

Status

Not yet recruiting

Sponsor

King's College Hospital NHS Trust

Enrolment target

Start

01 Nov 2026

Estimated completion

31 Dec 2027

Tenofovir Tenofovir Alafenamide Fumarate Chronic Kidney Diease Kidney Failure Pharmacokinetics

What is this study about?

This study is about a commonly used medication for HIV called Tenofovir Alafenamide Fumarate, often shortened to TAF. TAF is usually taken along with other medicines as part of a daily treatment for HIV.

When you take medicine, your body processes it, and your kidneys play a big part in removing these medicines from your system. If your kidneys aren't working as well as they should, medicines might stay in your body for longer, or at different levels than expected. This study wants to understand exactly how TAF (and another medicine it's often combined with, called emtricitabine) behaves in the bodies of people living with HIV who also have moderate to severe kidney problems. This is important because it helps doctors make sure patients with kidney issues are getting the safest and most effective dose of their HIV treatment.

By taking part, you would help researchers gather important information. This information could lead to better guidance for doctors on how to prescribe HIV medicines for people with kidney disease, ensuring they get the best possible care.

Key takeaways

Study examines HIV medication (TAF/FTC) in people with kidney disease.
Aims to understand how kidneys affect drug levels in the body.
Involves multiple blood samples over 24 hours.
You must already be on a stable TAF/FTC-containing HIV regimen.
Helps improve future HIV care for patients with kidney problems.

Who may be eligible?

This study is looking for adults (aged 18 or over) who are living with HIV and also have chronic kidney disease. Your kidney disease should be at a moderate or severe stage (meaning your kidneys aren't working as well as they should), but you shouldn't be on dialysis.

You must already be taking a stable HIV treatment regimen that includes Tenofovir Alafenamide Fumarate (TAF) and emtricitabine (FTC) at standard doses, and your HIV should be well controlled. Your doctors will check your medical records and perform tests to make sure you meet all the specific requirements for the study. For example, your HIV viral load needs to be very low, and you shouldn't have recently switched your HIV medication.

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 or older?
Do you have chronic kidney disease (not on dialysis)?
Are you currently taking HIV medication that includes TAF and FTC?
Has your HIV been well-controlled for at least 6 months?
Have you been on your current HIV medication for at least 3 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll need to agree to take your TAF/FTC medication in the morning for one week before coming for the main study day. On the main study day, you will visit the clinic, and blood samples will be taken several times over a 24-hour period. This will allow researchers to see how the medication levels change in your body over time. The study primarily involves these blood tests and clinic visits. There are no changes to your medication other than the specific timing of your morning dose for one week, and you will continue your usual HIV treatment. The total duration of your active participation will be focused around this 24-hour sampling period.

Potential risks and benefits

Participating in this study might not offer a direct personal benefit to you, but the information gained will help improve care for other people with HIV and kidney disease in the future. The main risks involve discomfort or bruising from the repeated blood samples. Your privacy will be protected, and your medical information kept confidential. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

King's College Hospital
Verified postcode
London, United Kingdom

Common questions

What is chronic kidney disease?

Chronic kidney disease means your kidneys aren't working as well as they should be, and this has been going on for a while. They might not be as good at filtering waste from your blood.

What are Tenofovir Alafenamide Fumarate (TAF) and emtricitabine (FTC)?

These are two common medications used together to treat HIV. They help keep the virus under control in your body.

Why do they need to take so many blood samples?

Taking blood samples at different times helps researchers track how the medicine moves through your body, how much is absorbed, and how quickly it's removed. This is called 'pharmacokinetics'.

Will I have to change my HIV medication?

No, you will continue your current stable HIV treatment. The only request is to take your TAF/FTC dose in the morning for one week before the main study day.

What does 'well-controlled HIV' mean?

It means your HIV viral load (the amount of virus in your blood) is very low, usually below detectable levels, thanks to your ongoing treatment.

How to find out more

Frank A Post, MBChB, MMed(med), PhD

frank.post@kcl.ac.uk 02078485779 Official trial record

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