Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation

Phase 3

Completed

Brief Summary: The study evaluated the efficacy and safety of a prolonged, continuous course of Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the standard of care upon initiation of the study, to 12 months of Valganciclovir.

Detailed Description: A multi-center two phase, double-blind, placebo controlled, randomized prospective study of 130 lung transplant recipients. Patients will be screened and consented prior to transplant. All consented patients will receive IV ganciclovir within 24 hours of transplant for not more than 14 days. Patients will enroll in Phase I of the study is an open label safety and efficacy analysis of three months of oral valganciclovir in adult transplant recipients who are at risk for CMV. After completion of 3 months of open label therapy, patients that meet the criteria for Phase II of the study will be randomized to 9 months of blinded therapy (Placebo/Valgan). Phase II of the study is designed to assess the efficacy of short course sequential IV ganciclovir followed by oral valganciclovir as compared to the extended period of oral valganciclovir prophylaxis in the prevention of CMV disease in at risk lung transplant recipients

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
1	valganciclovir	Valganciclovir 900 mg QD for 9 months post lung transplant.
2	Placebo	placebo for 9 months post lung transplant

Primary Outcome Measures

Name	Time	Method
Incidence of CMV End Organ Disease	over the course of 300 days after randomization	The primary study end point was CMV end-organ disease determined by positive tissue immunostain or characteristic histopathology assessed for within 300 days post randomization.
Incidence of CMV Syndrome	over the course of 300 days after randomization	CMV clinical syndrome, with either positive serum PCR or positive culture for CMV from bronchoalveolar lavage and at least 2 of the following: fever, leukopenia, thrombocytopenia, elevated liver function test results malaise, reduction in pulmonary function (FEV1) greater than 20percent of baseline, or radiographic infiltrate consistent with CMV (all in the absence of other causes)

Secondary Outcome Measures

Name	Time	Method
Non-CMV Infection	over the course of 300 days after randomization	non cmv opportunistic infections
Any CMV Infection	over the course of 300 days post randomization	Inclusive of CMV syndrome, disease, or infection not meeting primary end point.
Biopsy Proven Acute Lung Rejection	over the course of 300 days of randomization
Severity of Viremia	over the course of 300 days after randomization	upon diagnosis of cmv disease, the number of CMV DNA copies/mL as measured by PCR
Ganciclovir Resistance	over the course of 300 days post randomization	UL97 genotyping was done on all positive samples for CMV DNA at 1000 copies/mL, with resistance defined by the presence of 1 or more mutations shown by marker transfer to confer phenotypic ganciclovir resistance