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

Sponsor:	Duke University
Collaborator:	Roche Pharma AG
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00227370

Purpose

The purpose of this study is to determine the rate of CMV at one year in the short course (Phase I of the study) as compared to extended prophylaxis in Phase II of the study.

Condition	Intervention	Phase
Cytomegalovirus Infections	Drug: valganciclovir	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	A Phase III, Randomized, Double-Blind Comparison of Oral Valganciclovir and Placebo for Prevention of CMV After Lung Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Cytomegalovirus Infections Lung Transplantation

Drug Information available for: Valganciclovir hydrochloride Valganciclovir

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

For Enrollment Phase , using descriptive statistics, the safety and efficacy of an open label regimen that includes initial intravenous ganciclovir followed by oral valganciclovir for 3 months post transplant for patients at risk for CMV [ Time Frame: 90 days ] [ Designated as safety issue: No ]
For Randomization Phase , determine the rate of CMV disease at one year in the short course as compared to extended prophylaxis groups in Phase II [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine whether prevention of CMV disease after transplantation improves clinical outcomes. The researchers will compare the rates of acute rejection, hospitalization, non-CMV infections, and survival between the 2 groups over the study period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Determine how treatment with valganciclovir affects quality of life (QOL) by comparing serial measures of QOL between groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Determine how one year of oral valganciclovir affects ganciclovir resistance by comparing the rate of resistance between the groups [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	130
Study Start Date:	July 2003
Study Completion Date:	December 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 900 mg QD	Drug: valganciclovir valgan and placebo 900mg QD Other Name: valcyte Drug: valganciclovir anti-CMV Other Name: valcyte
Placebo Comparator: 2 900 mg QD	Drug: valganciclovir anti-CMV Other Name: valcyte

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227370

Locations

United States, North Carolina
DukeUMC
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Roche Pharma AG

Investigators

Principal Investigator:

Scott M Palmer, MD

Duke University

More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Palmer SM, Limaye AP, Banks M, Gallup D, Chapman J, Lawrence EC, Dunitz J, Milstone A, Reynolds J, Yung GL, Chan KM, Aris R, Garrity E, Valentine V, McCall J, Chow SC, Davis RD, Avery R. Extended valganciclovir prophylaxis to prevent cytomegalovirus after lung transplantation: a randomized, controlled trial. Ann Intern Med. 2010 Jun 15;152(12):761-9.

Responsible Party:	Scott Palmer, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:	NCT00227370 History of Changes
Other Study ID Numbers:	Val038
Study First Received:	September 26, 2005
Last Updated:	August 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duke University:

Acute rejection
Non-CMV infections
Resistance

Additional relevant MeSH terms:

Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir

Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012