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

Roche

Status and phase: Completed; Phase 4

Conditions: Cytomegalovirus Infections

Treatments: Drug: valganciclovir [Valcyte]; Drug: Ganciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00431353

MV17973

Details and patient eligibility

About

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.

Enrollment: 325 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

325 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: valganciclovir [Valcyte]

2

Experimental group

Treatment:

Drug: Ganciclovir