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Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
Not Recruiting
Trial ID: NCT01063829
Purpose
The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the
chances of the cytomegalovirus becoming active again and causing illness after an HBPC
transplant (allogeneic stem cell transplant).
Official Title
A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of 12 Weeks' Treatment With a New Antiviral HCMV Drug
Stanford Investigator(s)
Wes (Janice) Brown
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
Inclusion Criteria:
- Seropositive for HCMV IgG antibodies before transplantation
- First allogeneic Human blood precursor cell (HBPC) transplantation performed for 1 of
the following diagnoses: leukaemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's
lymphoma, multiple myeloma, myelodysplastic and myeloproliferative disorder
- Evidence of post transplantation engraftment
- Able to swallow tablets.
Exclusion Criteria:
- Previous anti-HCMV therapy after this allogeneic HBPC transplantation
- Mismatched or cord blood transplant recipients
- Current or history of end-organ HCMV disease
- Graft versus host disease (GVHD)
- Impaired liver function
- Reduced renal function
Intervention(s):
other: Placebo
drug: 60 mg AIC246
drug: 120 mg AIC246
drug: 240 mg AIC246
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
BMT Referrals
650-723-0822