Protocol
12-281
Full Title
A Phase 2, Randomized Study to Assess the Safety and Anti-Cytomegalovirus (CMV) Activity of Different Doses of Maribavir for Treatment of CMV Infections that are Resistant or Refractory to Treatment with Ganciclovir/Valganciclovir or Foscarnet in Transplant Recipients
Purpose
Cytomegalovirus (CMV) is a potential complication after stem cell transplantation. There are drugs used to treat CMV, but in some patients the virus has become resistant to these drugs. The purpose of this study is to evaluate three different doses of an investigational drug called maribavir in patients with CMV infection following stem cell transplantation which is not responding to treatment with standard antiviral medications (ganciclovir, valganciclovir, or foscarnet).
Maribavir works in a different way than these standard medications, and has been shown in laboratory studies to be very effective against CMV. It is taken orally (by mouth). Patients will be randomly assigned to take one of three doses (400 mg, 800 mg, or 1200 mg twice daily).
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have CMV following stem cell transplantation and not be responding to conventional antiviral medications.
- This study is open to patients age 12 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Genovefa Papanicolaou at 212-639-8361.
Disease(s)
Blood & Marrow Stem Cell Transplantation
Blood & Marrow Stem Cell Transplantation: Post-Transplant
Blood and Marrow Transplantation: Transplantation
Locations
Related Diseases
