Summary:
The SOLSTICE clinical research study for CMV in transplant patients
The SOLSTICE study is now enrolling transplant recipients with a cytomegalovirus (CMV) infection that is not responding to current treatments.
What is the SOLSTICE study?
The SOLSTICE study is a clinical research study designed to explore an investigational drug-maribavir-in stem cell transplant and solid organ transplant recipients whose CMV infections are not responding to current treatments. This investigational drug is given as an oral pill.
The main goal of the 22-week study is to see if maribavir works to clear CMV infections from transplant recipients who are not responding to current anti-CMV treatments. Participants will be treated for 8 weeks with either the investigational drug or the study doctor's treatment of choice. The study doctor's treatment of choice may be administered via pill or IV.
More on CMV...
CMV is a common virus that can infect almost anyone. In fact, the majority of adults are chronically (permanently) infected with it. Usually, the virus is "silent" (does not cause any symptoms) and is not detected in the blood when checked.
In transplant patients, however, it can be cause for great concern as the viral infection can become active, causing different types of issues. It can lead to transplanted organ failure and, in some cases, even death. While there could be several antiviral medications available to prevent or treat CMV, CMV infections among transplant recipients do not always respond to the currently available medicines.
What is the investigational drug being tested?
The investigational drug being investigated is maribavir, which is a new type of antiviral agent that works in a different way than existing anti-CMV drugs. A previous study demonstrated maribavir to be safe and effective in clearing CMV from the blood (and tissue) of transplant recipients across a range of doses.
Who is eligible for this clinical research study?
Participants may be eligible to participate in this study, if they:
- are 12 years of age or older
- weigh 77 pounds or more ( 35 kg)
- are the recipient of a stem cell transplant or solid organ transplant
- have a documented CMV infection that is not responding to current antiviral treatments
There are additional criteria for inclusion within this clinical study, which the study doctor will discuss with you, should you choose to participate.
Why should I consider participating?
By participating in the SOLSTICE study, you or your child are helping to advance the understanding of CMV infections in transplant recipients, and assisting with the potential approval of a new treatment option. The information gathered (including blood sampling and the other tests completed) may help other transplant recipients with CMV infections in the future.
Participating in the SOLSTICE study also allows you to receive study-related medical care from a team of specialists. Those who qualify for this study, whether they are assigned to receive the investigational drug-maribavir-or the study doctor's treatment of choice, will receive study-related medical care at no cost to them.