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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

This study has been suspended.

Sponsored by: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00241345
  Purpose

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.


Condition Intervention Phase
Cytomegalovirus Infections
Drug: Oral Valganciclovir
Drug: IV Ganciclovir
Phase III

MedlinePlus related topics:   Cytomegalovirus Infections   

ChemIDplus related topics:   Ganciclovir    Ganciclovir sodium    Valganciclovir    Valganciclovir hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Randomized Trial of Preemptive Treatment With Oral Valganciclovir Compared With IV Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The study end point for statistical purposes will be clearance of CMV viremia at 4 weeks from the start of therapy. Clearance of CMV viremia will be defined as a CMV viral load less than 5,000 copies/ml of whole blood.

Secondary Outcome Measures:
  • All patients will be followed for 6 months after randomization.

Estimated Enrollment:   120
Study Start Date:   March 2004

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 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.
  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241345

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

Sponsors and Collaborators
Washington University School of Medicine

Investigators
Principal Investigator:     Ravi Vij, M.D.     Washington University School of Medicine    
  More Information


Study ID Numbers:   04-0274
First Received:   October 17, 2005
Last Updated:   May 22, 2007
ClinicalTrials.gov Identifier:   NCT00241345
Health Authority:   United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
post transplant  
Any patient receiving an allogeneic bone marrow or peripheral blood stem cell transplant at Washington University Medical Center  

Study placed in the following topic categories:
Virus Diseases
Valganciclovir
Cytomegalovirus Infections
Ganciclovir
DNA Virus Infections
Cytomegalic inclusion disease
Cytomegalovirus
Herpesviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
Therapeutic Uses
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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