Overview

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

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Scott Palmer
Collaborator:
Roche Pharma AG
Treatments:
Ganciclovir
Valganciclovir
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