Cytomegalovirus Infections
Conditions
Keywords
post transplant, Any patient receiving an allogeneic bone marrow or peripheral blood stem cell transplant at Washington University Medical Center
Brief summary
The purpose of this trial is to determine if preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing cytomegalovirus (CMV) viremia as determined by quantitative CMV polymerase chain reaction (PCR) assay in patients who have undergone bone marrow or peripheral blood stem cell transplant.
Detailed description
* To study the effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR. * To determine the incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir. * To compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir. * To determine the toxicity profile of valganciclovir. * To screen for mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment. * To determine if patients treated with PO valganciclovir have ganciclovir drug levels which are equivalent to those seen in historical control subjects treated with PO valganciclovir.
Interventions
DRUGValganciclovir
DRUGGanciclovir
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients receiving allogeneic peripheral blood stem cell transplant from either a related or unrelated donor at Washington University Medical Center. * An initial episode of CMV viremia. * At the time of randomization: * ANC greater than or equal to 1000 * Age greater than or equal to 18 * Adequate renal function with creatinine clearance greater than 10 ml/min * Total bilirubin less than or equal to 3.0
Exclusion criteria
* Current GI graft versus host disease grade III-IV * Development of CMV disease prior to or at the time of the first detection of CMV viremia by PCR * Uncontrolled emesis or diarrhea (greater than or equal to 4 episodes per day) for 2 consecutive days * Pregnant or nursing female patient * Known hypersensitivity to ganciclovir
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| If preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing CMV viremia as determined by quantitative CMV PCR assay in patients who have undergone allogeneic bone marrow or peripheral stem cell transplant. | 4 weeks from start of therapy | Clearance of CMV viremia will be defined as CMV viral load less than 5,000 copies/ml of whole blood. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir. | 6 months |
| Compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir. | 6 months |
| Effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR. | 6 months |
| Mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment | 14 days |
| Determine if patients treated with PO valganciclovir have ganciclovir drug levels which are equivalent to those seen in historical control subjects treated with PO valganciclovir. | 6 months |
| Toxicity profile of valganciclovir | 6 months |
Countries
United States
Outcome results
None listed