NCT03088553

Observational Study Comparing the Efficacy of Ganciclovir as a Function of Blood Exposure to the Drug During a Curative or Preemptive Treatment

Etude Observationnelle Comparant l'efficacité du GANciclovir en Fonction de l'EXposition Sanguine au médicament

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 138 (estimated)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to better define the target range of ganciclovir trough concentrations by investigating the relationship between ganciclovir concentration and the time to undetectable CMV-DNA load, in preemptive and curative treatments by (val)ganciclovir.

Detailed description

The primary objective of the study is to determine whether higher concentrations of ganciclovir can reduce the time of negation of the CMV-DNA load. Secondary objectives are to determine the concentration-toxicity relationship of ganciclovir and the relationship between concentrations of ganciclovir and apparition of CMV gene mutations responsible of drug resistance. Each week, trough concentrations of ganciclovir are measured, associated with control of CMV-DNA load and all biological analysis currently necessary for the monitoring of the infection.

Conditions

• Solid Organ Transplantation

Interventions

Type	Name	Description
DRUG	Therapeutic Drug Monitoring	Trough concentration of ganciclovir and viral load measurement at each follow-up visit.

Timeline

• Start date: 2017-02-21
• Primary completion: 2023-12-21
• Completion: 2024-06-21
• First posted: 2017-03-23
• Last updated: 2023-04-12

Locations

1 site across 1 country: France