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

Inclusion Criteria for Phase I: Adult lung transplant recipients age 18 or older At risk for CMV (donor or recipient serology must be positive for CMV) Adequate hematological and renal function, On intravenous (IV) ganciclovir within 24 hours of surgery Agreement to use effective methods of contraception Negative pregnancy Tolerate oral medications within 2 weeks of transplant Negative baseline CMV PCR Able to understand and sign the informed consent Exclusion Criteria for Phase 1: Repeat transplantation Mechanical ventilation at study entry Oral or intravenous ganciclovir treatment outside the study protocol Invasive fungal infection Participation in another investigational study Acute CMV infection or disease Anti-CMV therapy within 30 days before enrollment Uncontrolled diarrhea or malabsorption Allergic reaction to study drug Required use of prohibited medications Lactating women Pregnancy Renal failure Inclusion Criteria for Phase II: Negative serial post transplant PCRs at day 75 Negative bronchial cultures for CMV Adequate hematological and renal function at day 75 IV ganciclovir for up to 2 weeks post operation and open label up to day 90 Effective contraceptives Negative pregnancy Exclusion Criteria Phase II: Renal failure Serious adverse events (SAE) related to study drug CMV disease (study endpoint) Withdraw consent for Phase II