SOLSTICE 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.
The main goal of the 22-week study is to see if maribavir works (at 400 mg twice-daily) compared to study doctor’s treatment of choice to clear the virus from the blood. Participants will be randomly assigned to receive either the investigational drug or the study doctor’s treatment of choice for 8 weeks if they meet the criteria outlined in the protocol. The study will also assess participants for an additional 12 weeks after treatment to confirm that the study participants remain free of CMV infection (no virus detected in blood).
Study participants who receive an anti-CMV drug (not maribavir), and who don’t show improvement by week 3, may be eligible for the Rescue Arm, during which participants will receive maribavir 400 mg twice-daily for 8 weeks. This treatment would be followed by a 12-week observation period. These participants may have an overall study duration of up to 29 weeks.