RecruitingPHASE3INTERVENTIONAL

Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections

This study is looking at a new way to treat a common infection called Cytomegalovirus (CMV) in people who have had a kidney transplant. CMV can be serious for these patients. Currently, drugs like valganciclovir are used, but they don't always work perfectly and can have side effects or stop being effective over time. Researchers believe that adding a drug called letermovir to valganciclovir might clear up the infection faster and help prevent it from becoming resistant to treatment. Patients in this study will either receive the new combination or valganciclovir with a dummy drug (placebo) alongside to see which approach is more effective and well-tolerated. The main goal is to find a better treatment for CMV in kidney transplant patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

14 Aug 2024

Estimated completion

01 Nov 2027

Cytomegalovirus Infection

What is this study about?

If you've had a kidney transplant, your immune system is weaker, which can make you more likely to get infections like Cytomegalovirus, or CMV. CMV is a common virus, but it can cause serious problems for people with weakened immune systems. The usual treatment for CMV is a drug called valganciclovir, but sometimes it doesn't work as well as doctors would like, or it can cause side effects. There's also a risk that the virus might become resistant to the drug over time, meaning the treatment stops working.

This study, which is in its later stages of testing (Phase 3), is exploring whether combining valganciclovir with another drug called letermovir could be a more effective treatment. Previous lab studies suggest that these two drugs might work well together to fight CMV. Doctors hope that this combination could clear the infection more quickly and also help reduce the chance of the virus becoming resistant to treatment, which is a big concern.

In this study, kidney transplant patients who have CMV infection will be split into two groups by chance. One group will receive valganciclovir along with letermovir. The other group will receive valganciclovir along with a placebo, which looks like letermovir but has no active medicine. This allows the researchers to fairly compare how well each treatment works. The study will carefully watch if the amount of CMV in the blood goes down and if patients' symptoms improve, aiming for a "treatment success" within about 12 weeks.

Key takeaways

This study is for kidney transplant patients with CMV infection.
It tests if combining letermovir with valganciclovir works better than valganciclovir alone.
The goal is faster infection clearance and less drug resistance.
You'll either get the combination or valganciclovir with a dummy pill.
Participation involves regular clinic visits and blood tests.
You can stop participating at any time.

Who may be eligible?

To be able to join this study, you must be at least 18 years old and have received a kidney transplant. You need to have a confirmed CMV infection that your doctor thinks needs to be treated with valganciclovir. Your CMV infection should also be fairly new, meaning you haven't been on other CMV medicines for more than 3 days for this specific infection.

There are also some things that would mean you can't join. For example, if your doctor believes your current CMV infection isn't getting better because you haven't been taking your medicines properly, or if your CMV infection is already known to be resistant to valganciclovir or letermovir. Pregnant women or women who could become pregnant and are not using effective birth control methods cannot participate. Men also need to use effective birth control during and for a period after the study.

Additionally, you must be able to speak French, have a life expectancy of at least 8 weeks, and be affiliated with a social security system or similar.

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?
Have you had a kidney transplant?
Do you have an active CMV infection that needs treatment?
Can you speak French?
Are you able to use effective birth control (if applicable)?
Have you been on CMV treatment for this infection for less than 3 days?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned by chance to one of two groups: either you'll receive letermovir and valganciclovir, or you'll receive a placebo (dummy drug) instead of letermovir, alongside valganciclovir. You'll take these medications until your CMV infection is treated successfully or if the treatment doesn't work, for a maximum of 12 weeks.

During this time, you will have regular visits to the clinic where doctors will take blood samples to check your CMV levels and monitor your health. They will also ask about any symptoms you might have. The study will involve closely tracking your progress to see how effectively the treatment is working in your body and if you experience any side effects. After the treatment period, there will be follow-up appointments for a short while to ensure the infection remains cleared.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new combination treatment that could be more effective at clearing your CMV infection and reducing the risk of drug resistance. However, as with any medical treatment, there are potential risks and side effects associated with the medications being studied, and you might not personally benefit from taking part. You will be closely monitored for any reactions or side effects that occur. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Hôpital Necker Enfants Malades
Verified postcode
Paris, France· Recruiting
Hôpital de la Pitié Salpêtrière, Service de Néphrologie
Verified postcode
Paris, France· Recruiting
Hôpital Européen Georges Pompidou
Verified postcode
Paris, France· Recruiting
Hôpital Necker Enfants Malades - SMIT
Verified postcode
Paris, France· Recruiting
Centre 011-Hôpital Bichat, Service de Néphrologie
Verified postcode
Paris, France· Recruiting

Common questions

What is CMV infection?

CMV (Cytomegalovirus) is a common virus. For people with strong immune systems, it usually doesn't cause problems. But for kidney transplant patients, whose immune systems are weaker, it can cause serious illness.

What drugs are being tested?

This study is testing a combination of two drugs: letermovir and valganciclovir. Valganciclovir is a standard treatment, and letermovir is a newer drug that might help it work better.

Why is this study important for kidney transplant patients?

CMV infection can be a big challenge for kidney transplant patients. This study aims to find a more effective and safer way to treat it, hoping to clear the infection faster and prevent it from becoming resistant to medicines.

Will I know which treatment I'm getting?

No, you will not know if you are getting letermovir or the placebo (dummy drug) alongside valganciclovir. This is called a 'blinded' study, which helps ensure the results are fair and accurate.

How long will the study treatment last?

The treatment part of the study will last for up to 12 weeks, or less if your infection is successfully treated earlier.

How to find out more

Pierre FRANGE, MD, PhD

pierre.frange@aphp.fr +33 1.44.49.49.61 Official trial record

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