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VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00431353
First received: February 2, 2007
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with intravenous ganciclovir for the treatment of CMV disease in solid organ transplant recipients. Eligible patients will be randomized to receive either 1)Valcyte 900mg po bid or 2)ganciclovir 5mg/kg iv bid. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Condition Intervention Phase
Cytomegalovirus Infections
 Drug: valganciclovir [Valcyte]
Drug: Ganciclovir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of treatment success (CMV viremia BLQ) [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to eradication of CMV viremia, percentage of patients with resolution of symptoms, percentage of patients with eradication of CMV viremia, time to CMV viremia recurrence, effect on HHV-6, HHV-7 and EBV viremia. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, appearance of ganciclovir resistance. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 325
Study Start Date: April 2004
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: valganciclovir [Valcyte]
900mg po bid for 21 days
Experimental: 2 Drug: Ganciclovir
5mg/kg iv bid for 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients >=18 years of age;
  • recipients of solid organ(s) transplant;
  • virologic and clinical evidence of CMV disease after transplantation;
  • patients of childbearing potential must be prepared to use effective contraception throughout, and for 90 days after the end of the study.

Exclusion Criteria:

  • life-threatening CMV disease according to the investigator's judgment;
  • pregnant or lactating women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431353

  Show 50 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00431353     History of Changes
Other Study ID Numbers: MV17973
Study First Received: February 2, 2007
Last Updated: June 3, 2013
Health Authority: Norway: Norwegian Medicines Agency

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 June 18, 2013