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.

First Received: February 2, 2007 Last Updated: May 13, 2009 History of Changes

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00431353

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cytomegalovirus Infections

Drug Information available for: Ganciclovir Ganciclovir sodium Valganciclovir hydrochloride Valganciclovir

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 Completion Date:	August 2008

Arms	Assigned Interventions
1: Experimental	Drug: valganciclovir [Valcyte] 900mg po bid for 21 days
2: Experimental	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 51 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MV17973
Study First Received:	February 2, 2007
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00431353 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:

Virus Diseases
Anti-Infective Agents
Valganciclovir
Therapeutic Uses
Cytomegalovirus Infections
Ganciclovir

DNA Virus Infections
Infection
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010