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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Cytomegalovirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Valganciclovir 900 mg QD for 9 months post lung transplant.

Group Type ACTIVE_COMPARATOR

valganciclovir

Intervention Type DRUG

valgan 900mg QD x 9 months post lung transplant

2

placebo for 9 months post lung transplant

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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valganciclovir

valgan 900mg QD x 9 months post lung transplant

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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valcyte

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

* Renal failure
* Serious adverse events (SAE) related to study drug
* CMV disease (study endpoint)
* Withdraw consent for Phase II

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No