VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
Phase 4
Completed
- Conditions
- Cytomegalovirus Infections
- Interventions
- Registration Number
- NCT00431353
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 325
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 valganciclovir [Valcyte] - 2 Ganciclovir -
- Primary Outcome Measures
Name Time Method Incidence of treatment success (CMV viremia BLQ) Day 21
- Secondary Outcome Measures
Name Time Method 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. Throughout study AEs, laboratory parameters, appearance of ganciclovir resistance. Throughout study