Population Pharmacokinetics of Antiretroviral in Children
POPARV
1 other identifier
observational
65
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2017
CompletedStudy Start
First participant enrolled
June 16, 2017
CompletedFirst Posted
Study publicly available on registry
June 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2022
CompletedSeptember 15, 2025
September 1, 2025
5 years
June 13, 2017
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (1)
Composite measure of the inter-individual variability
through study completion, an average of 2 years
Study Arms (1)
antiretroviral dosage
titration of Dolutegravir, Raltegravir, Rilpivirine, Nevirapine, Atazanavir, Darunavir, Ritonavir
Interventions
Eligibility Criteria
Minor patient treated by one or more antiretroviral and for which a blood test has been performed
You may qualify if:
- 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
You may not qualify if:
- Concentration too low below the limit of quantification (indicating an absence of medication
- patient with doubt about compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cochin Hospital
Paris, paris, 75014, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Marc TRELUYER
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 21, 2017
Study Start
June 16, 2017
Primary Completion
June 16, 2022
Study Completion
June 16, 2022
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share