Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients - Full Text View

Purpose

The objectives of this study were:

To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days of treatment.
To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.).
Evaluate the security of this treatment with valganciclovir.

Condition	Intervention	Phase
Cytomegalovirus Infection	Drug: Single arm (ganciclovir and valganciclovir)	Phase IV

MedlinePlus related topics:

Cytomegalovirus Infections

Drug Information available for:

Ganciclovir Ganciclovir sodium Valganciclovir Valganciclovir hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	Phase IV.II Pilot Study of Treatment of Cytomegalovirus Infection With a Brief Induction With Ganciclovir i.v. Followed by Valganciclovir Oral in Solid Organ Transplant Patients.

Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:

Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC). [ Time Frame: Baseline, day 5, 10, 15, 21 of treatment and day 30, 60 and 90 of follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dissapareance of Cytomegalovirus viremia measured by PCR, determined in plasma samples. [ Time Frame: Basal, day 5, 10, 15 and 21 of treatment and 30, 60 and 90 of treatment. ] [ Designated as safety issue: No ]
Area under the curve (AUC) of Ganciclovir after ganciclovir i.v. and valganciclovir oral in steady state. [ Time Frame: Day 5 (ganciclovir i.v) and day 15 (valganciclovir oral) ] [ Designated as safety issue: No ]

Enrollment:	21
Study Start Date:	March 2004
Study Completion Date:	July 2008
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

Single arm: Experimental

Patients received a short induction of IV ganciclovir (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg bid (after meals) for 16 days up to complete 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockcroft-Gault equation)

Drug: Single arm (ganciclovir and valganciclovir)

Patients received a short induction of IV ganciclovir at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir at 900 mg bid (after meals) for 16 days up to complet 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockroft-Gault equation)

Detailed Description:

SOT recipients (kidney, liver and heart transplant) presenting CMV infection or disease were eligible for inclusion if they were ≥18 years of age and presented a positive CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC). Patients excluded were those with severe CMV tissue invasive disease, unable to receive oral medication, absolute neutrophil counts less than 500/ mm3, platelets <25000 platelets/mm3, Hemoglobin< 80g/l or estimated glomerular filtration rate< 10 mL/min (according to the Cockcroft-Gault formula).

Patients received a short induction treatment with ganciclovir i.v (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at the dose of 5 mg/kg/12h, by a peripherical vein infusion of one hour, during 5 days followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg/12h during 16 days, after meals, until complete a total of 21 days of treatment. In patients with impaired renal function ganciclovir i.v. and oral valganciclovir doses were adjusted at each visit according to estimated Glomerular Filtration Rate (GFR) by Cockcroft-Gault equation, as recommended by the manufacturer.

Eligibility

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

Criteria

Inclusion Criteria:

≥18 years of age, solid organ transplant recipients.
presented a CMV infection demonstrated by CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC).
gave written informed consent.

Exclusion Criteria:

HIV patients.
Multiorganic transplant.
Severe CMV tissue invasive disease.
Unable to receive oral medication.
absolute neutrophil counts less than 500/ mm3.
Platelets <25000 platelets/mm3.
Hemoglobin< 80g/l.
Estimated glomerular filtration rate< 10 mL/min (according to the Cockcroft-Gault formula)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730769

Locations


Spain, Barcelone
	Hospital Universitari Bellvitge- Transplant Departments (Liver, Heart and Kidney)
	L'Hospitalet de Llobregat, Barcelone, Spain, 08907

Sponsors and Collaborators

Hospital Universitari de Bellvitge

Hoffmann-La Roche

Investigators


Study Chair:	Salvador - Gil-Vernet, Medicine	Nephrology Department. Hospital Universitari of Bellvitge

More Information

Responsible Party:	Nephrology Department-Hospital Universitari Bellvitge ( Nephrology Department- Dr. Gil-Vernet )
Study ID Numbers:	VALGAN-03
First Received:	August 5, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00730769
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:

Valganciclovir

Ganciclovir

Pharmacokinetics

Solid organ transplantation

Transplant

Study placed in the following topic categories:

Virus Diseases

Valganciclovir

Cytomegalovirus Infections

Ganciclovir

DNA Virus Infections

Cytomegalic inclusion disease

Cytomegalovirus

Herpesviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents

Communicable Diseases

Therapeutic Uses

Infection

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

Sponsors and Collaborators:	Hospital Universitari de Bellvitge Hoffmann-La Roche
Information provided by:	Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:	NCT00730769