Clinical trial
Population Pharmacokinetics of Antiretroviral in Children
Name
NI17010HLJ
Description
The purpose of this study is to develop population pharmacokinetic models for antiretroviral drugs in a pediatric population.
The interest of these models is multiple :
* describe the pharmacokinetics of these drugs in children and explain the inter-individual variability of concentrations through covariates such as weight, age, sex, smoking status, co-treatments and bilirubin;
* estimate maximum, minimum and exposure concentrations from the individual pharmacokinetic parameters for each patient;
* propose adaptations of doses for certain classes of children (according to age, weight etc.) and individualize the doses.
Trial arms
Trial start
2017-06-16
Estimated PCD
2022-06-16
Trial end
2022-06-16
Status
Completed
Treatment
Dolutegravir
Dosage
Arms:
antiretroviral dosage
Raltegravir
Dosage
Arms:
antiretroviral dosage
Rilpivirine
Dosage
Arms:
antiretroviral dosage
Nevirapine
Dosage
Arms:
antiretroviral dosage
Atazanavir
Dosage
Arms:
antiretroviral dosage
Darunavir
Dosage
Arms:
antiretroviral dosage
Ritonavir
Dosage
Arms:
antiretroviral dosage
Size
65
Primary endpoint
Volume of distribution
through study completion, an average of 2 years
Absorption constant
through study completion, an average of 2 years
Clearance
through study completion, an average of 2 years
Eligibility criteria
Inclusion Criteria:
* Children from 0 to 18 years;
* Treatment with one antiretroviral drug (s) studied (dolutegravir, raltégravir, rilpivirine, nevirapine, atazanavir, darunavir, ritonavir));
* Blood dosage of the drug (s) as part of their therapeutic follow-up in the Pharmacology laboratory of the Cochin hospital between 2007 and 2017
Exclusion Criteria:
* Concentration too low below the limit of quantification (indicating an absence of medication
* patient with doubt about compliance
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 65, 'type': 'ACTUAL'}}
Updated at
2023-02-21
1 organization
7 products
1 indication
Organization
Assistance Publique - Hôpitaux de ParisProduct
DolutegravirIndication
HIV infectionProduct
RaltegravirProduct
RilpivirineProduct
NevirapineProduct
AtazanavirProduct
DarunavirProduct
Ritonavir