HORUS-Cytomegalovirus Open Proof-of-concept Exploratory trial
After receiving an organ transplant, patients take medications to stop their immune system from rejecting the new organ. However, these medicines can make it harder for the body to fight off common bugs, such as cytomegalovirus (CMV). While CMV is usually harmless in healthy people, it can cause complications for transplant recipients. This clinical trial is testing two anti-rejection medicines, everolimus and mycophenolic acid, in adults who have had a solid organ transplant and currently have CMV. Doctors want to find out whether one medicine helps control the virus better than the other. Over a three-week period, researchers will measure how much virus is in the blood and examine how the immune system responds. The goal is to discover safer, more effective ways to manage CMV while keeping transplanted organs healthy and working well.
At a glance
What is this study about?
When someone receives a solid organ transplant—such as a kidney, liver, or heart—their immune system naturally sees the new organ as foreign. To prevent the body from rejecting it, doctors prescribe lifelong medicines known as immunosuppressants. While these medicines protect the new organ, they also lower the body's natural defences against everyday germs and infections.
One common virus that can cause problems after a transplant is cytomegalovirus, often called CMV. Most healthy adults catch CMV at some point in their lives without ever knowing it, as a normal immune system keeps it asleep. In transplant patients, however, the virus can wake up or cause an active infection. Active CMV can cause fever, tiredness, and potentially damage the transplanted organ if it is not kept under control.
This study, called HORUS-CMV, looks closely at two anti-rejection medications: everolimus and mycophenolic acid. Researchers believe these medicines may interact with the virus in different ways. By measuring the level of CMV in the blood before and three weeks after treatment, the study aims to see how these medicines affect viral growth and the patient's immune system. Findings from this research could help doctors choose the best medication plans for future transplant patients.
Key takeaways
- The trial looks at treating CMV infection in people with an organ transplant.
- It compares how medicines like everolimus and mycophenolic acid affect virus levels.
- The main checkpoint is three weeks after starting the study treatment.
- Participation involves regular blood tests and close health checks.
- Joining is completely optional and does not affect your standard NHS care.
Who may be eligible?
This study is designed for adults aged 18 and older who have received a solid organ transplant, such as a kidney, liver, or heart. Participants must have an active CMV infection that requires monitoring or treatment.
Because this trial looks at specific anti-rejection medicines, your transplant team will need to check your current medications, your overall health, and how well your transplanted organ is functioning. People who are allergic to the study medicines or who have other severe medical complications may not be able to join.
Your specialist doctor will review your medical history and recent blood test results to confirm whether taking part would be safe and appropriate 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.
- I am aged 18 or older.
- I have had a solid organ transplant (such as a kidney, liver, or heart).
- I have been diagnosed with an active CMV (cytomegalovirus) infection.
- I am willing to attend hospital visits and have regular blood tests over several weeks.
What does participation involve?
If you take part, you will be prescribed study medications (such as everolimus or mycophenolic acid) under the close supervision of your transplant team. The main part of the study tracks changes over three weeks. You will need to attend hospital clinic visits for regular health checks and blood tests. These blood samples will measure the amount of CMV virus in your blood and look at how your immune cells are reacting. Your medical team will monitor you closely for any side effects and ensure your transplanted organ continues to work properly. Your doctor will explain the exact visit schedule and any follow-up appointments before you agree to join.
Potential risks and benefits
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Common questions
What is CMV?
CMV stands for cytomegalovirus. It is a very common virus that is usually harmless, but it can cause illness in people with weakened immune systems, including transplant recipients.
Will this study replace my current transplant care?
No. The study is run alongside your regular transplant care, and your doctors will continue to monitor your new organ just as carefully as before.
How is CMV measured in the study?
CMV levels are measured using routine blood tests that count the amount of virus present in your bloodstream.
Do I have to pay for any study medicines or tests?
No, all study-related treatments and tests are provided free of charge through the clinical trial.
What happens if I change my mind about taking part?
You can withdraw from the trial at any point without giving a reason. Your doctors will simply switch you back to standard care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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