Skip to main content
OpenTrials
Completed

NCT Number: NCT00730769

Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cytomegalovirus Infection Amino Acid Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cytomegalovirus Infections DNA Virus Infections Genetic Diseases, Inborn Herpesviridae Infections Infections Metabolic Diseases Metabolism, Inborn Errors Mitochondrial Diseases Multiple Acyl Coenzyme A Dehydrogenase Deficiency Nutritional and Metabolic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari Bellvitge- Transplant Departments (Liver, Heart and Kidney)

L'Hospitalet de Llobregat, Barcelone, 08907, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Single arm (ganciclovir and valganciclovir)

Drug

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®)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

Salvador Gil-Vernet

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Aug 8, 2008
Registry last updated
Sep 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.