Clinical Trial: Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Pa

Brief Summary:

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.

Detailed Summary:

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.


Sponsor: Salvador Gil-Vernet

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. ]
  • 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) ]


Original Secondary Outcome: Same as current

Information By: Hospital Universitari de Bellvitge

Dates:
Date Received: August 5, 2008
Date Started: March 2004
Date Completion:
Last Updated: September 19, 2011
Last Verified: September 2011