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

CompletedPhase 3

Sponsor: Duke University

Conditions: Cytomegalovirus Infections

Interventions: valganciclovir, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Durham, North Carolina, United States