Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Tenofovir Alafenamide Fumarate and Epstein-Barr virus activity in people with MS – The TAF-MS study

The TAF-MS study is exploring a new approach for people living with Multiple Sclerosis (MS). It investigates whether a medicine called Tenofovir Alafenamide Fumarate (TAF), also known as Vemlidy, can influence the Epstein-Barr virus (EBV) in MS patients. There's growing interest in the potential connection between EBV and MS, and this study aims to understand if reducing EBV activity could be beneficial. Participants will take TAF as a capsule, along with another MS treatment called Tysabri. The main goal is to monitor for any serious side effects over 24 weeks. Researchers will also check changes in EBV activity in blood and saliva samples. This is an early-stage study, designed to gather more information about this potential link.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Helse Bergen HF

Enrolment target

Start

20 Nov 2023

Multiple sclerosis

What is this study about?

This study, called TAF-MS, is looking into new ways to help people with Multiple Sclerosis (MS). Researchers are interested in a common virus called the Epstein-Barr virus (EBV). Most people get EBV at some point, often causing no symptoms or an illness like glandular fever. However, some scientists believe EBV might play a role in developing or worsening MS.

In this study, doctors are investigating whether a medicine called Tenofovir Alafenamide Fumarate, which you might know as Vemlidy, could affect EBV activity in people with MS. This medicine usually helps treat other conditions, but researchers want to see if it can also reduce the amount of EBV in people with MS. Participants will be taking this medicine alongside another MS treatment called Tysabri. This is an exploratory study, meaning it's an early step to see if this approach is worth researching further.

The main aim of the study is to closely monitor for any serious health problems that might occur after starting the study treatment. They will also be looking at how EBV levels change in your body. By understanding more about the link between EBV and MS, and whether medicines like Tenofovir Alafenamide Fumarate can help, researchers hope to find new ways to manage MS in the future.

Key takeaways

This study explores a connection between EBV and MS.
It tests a medicine called Vemlidy with Tysabri for MS patients.
The main focus is on safety and changes in EBV activity.
It's an early-stage study, not a guaranteed new treatment.
Participation involves taking medication and regular check-ups.
The study lasts for 24 weeks of active monitoring.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. The study is open to both men and women.

More detailed criteria about your specific MS diagnosis, other health conditions, and current medications will be discussed with you by the study team. This is to make sure the study is safe and suitable for you.

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?
Do you have a diagnosis of Multiple Sclerosis?
Are you comfortable potentially taking new medication?
Are you able to attend regular study appointments?
Are you happy to provide blood and saliva samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given a capsule-coated tablet called Tenofovir Alafenamide Fumarate (Vemlidy) to take. You'll also receive Tysabri, which is given as a liquid through a drip (infusion).

Throughout the study, you'll have regular visits where doctors and nurses will check your health. They'll also take blood and saliva samples to see how the treatments are affecting you and the Epstein-Barr virus. These checks will happen at the start, and then again at 2, 8, and 24 weeks after you begin the study treatment. The total duration of the main study observations will be 24 weeks.

Potential risks and benefits

Potential benefits of participating include contributing to medical knowledge that could help future MS patients and receiving close medical monitoring. While the medicines used are approved for other conditions, there's always a risk of side effects, which the study team will discuss in detail. The main goal of this particular study is to track any serious side effects. You have the right to withdraw from the study at any time without giving a reason, and it won't affect your ongoing 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
Norway

Common questions

What is the Epstein-Barr virus (EBV)?

EBV is a very common virus that most people catch at some point. It often causes no problems, but can sometimes lead to glandular fever.

What is Tenofovir Alafenamide Fumarate (Vemlidy)?

This is a medicine that is already approved to treat certain conditions. In this study, we're exploring if it can also help with EBV activity in people with MS.

What is Tysabri?

Tysabri is a common treatment for Multiple Sclerosis that helps to reduce relapses and slow down the progression of the disease.

Will this study cure my MS?

No, this is an early-stage study to gather more information about a potential link between EBV and MS and a new treatment approach. It's not designed to be a cure.

How long will I be in the study?

The main part of the study involves monitoring for 24 weeks after you start the treatment.