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 terminated.
(Due to low accrual)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00241345
First received: October 17, 2005
Last updated: July 22, 2013
Last verified: July 2013
  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: Valganciclovir
Drug: Ganciclovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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. [ Time Frame: 4 weeks from start of therapy ] [ Designated as safety issue: Yes ]
    Clearance of CMV viremia will be defined as CMV viral load less than 5,000 copies/ml of whole blood.


Secondary Outcome Measures:
  • Effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Toxicity profile of valganciclovir [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: June 2004
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
IV ganciclovir (5mg/kg every 12 hours for 7 days followed by 5mg/kg every 24 hours for 7 days. If CMV viral load <5000 copies/ml after 14 days then 5mg/kg every 24 hours for a total of 21 total days of therapy. If CMV viral load >5000/ml but less than index viral load after 14 days then 5mg/kg every 24 hours for a total of 28 total days of therapy. If CMV viral load >= index viral load after 14 days then 5mg/kg every 12 hours for 7 days. If repeat CMV viral load is <= the previous CMV viral load then 5mg/kg every 12 hours for an additional 7 days.
Drug: Ganciclovir
Experimental: Group B
PO valganciclovir (900 mg every 12 hours for 7 days followed by 900 mg every 24 hours for 7 days. If CMV viral load <5000 copies/ml after 14 days then 900 mg every day until 21 total days of therapy. If CMV viral load >5000 copies/ml after 14 days but less than the index viral load then 900 mg every day until 28 total days of therapy. If CMV viral load >= the index viral load 900 mg every 12 hours for 7 days, if CMV viral load <= to previous viral load then 900 mg every 12 hours for another 7 days.
Drug: Valganciclovir

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00241345     History of Changes
Other Study ID Numbers: 04-0274
Study First Received: October 17, 2005
Last Updated: July 22, 2013
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

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir
Valganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014