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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00431353
Recruitment Status : Completed
First Posted : February 5, 2007
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Cytomegalovirus Infections Drug: Ganciclovir Drug: valganciclovir [Valcyte] Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2004
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Experimental: 1 Drug: valganciclovir [Valcyte]
900mg po bid for 21 days

Experimental: 2 Drug: Ganciclovir
5mg/kg iv bid for 21 days

Primary Outcome Measures :
  1. Incidence of treatment success (CMV viremia BLQ) [ Time Frame: Day 21 ]

Secondary Outcome Measures :
  1. 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 ]
  2. AEs, laboratory parameters, appearance of ganciclovir resistance. [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00431353

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Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche Identifier: NCT00431353    
Other Study ID Numbers: MV17973
First Posted: February 5, 2007    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action