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Trial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant

2014-08-27 03:48:10 | BioPortfolio

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.

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 correlate T-cell subset counts with viral loads.

- 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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cytomegalovirus Infections

Intervention

Oral Valganciclovir, IV Ganciclovir

Location

Washington University School of Medicine
St. Louis
Missouri
United States
63110

Status

Completed

Source

Washington University School of Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:48:10-0400

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