Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Salvador Gil-Vernet, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT00730769
First received: August 5, 2008
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

The objectives of this study were:

  1. 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.
  2. To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.).
  3. Evaluate the security of this treatment with valganciclovir.

Condition Intervention Phase
Cytomegalovirus Infection
Drug: Single arm (ganciclovir and valganciclovir)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Experimental: Single arm
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)
Other Names:
  • Ganciclovir (Cymevene®)
  • Valganciclovir (Valcyte®)

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

Locations
Spain
Hospital Universitari Bellvitge- Transplant Departments (Liver, Heart and Kidney)
L'Hospitalet de Llobregat, Barcelone, Spain, 08907
Sponsors and Collaborators
Salvador Gil-Vernet
Roche Pharma AG
Investigators
Study Chair: Salvador - Gil-Vernet, Medicine Nephrology Department. Hospital Universitari of Bellvitge
  More Information

No publications provided by Hospital Universitari de Bellvitge

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Salvador Gil-Vernet, Nephrologist, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT00730769     History of Changes
Other Study ID Numbers: VALGAN-03
Study First Received: August 5, 2008
Last Updated: September 19, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:
Valganciclovir
Ganciclovir
Pharmacokinetics
Solid organ transplantation
Transplant

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir
Valganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014