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Population Pharmacokinetics of Antiretroviral in Children

NCT03194165 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

  • Minor Patient Treated by One or More Antiretroviral and for Which a Blood Test Has Been Performed

Interventions

BIOLOGICAL

Dolutegravir

Dosage

BIOLOGICAL

Raltegravir

Dosage

BIOLOGICAL

Rilpivirine

Dosage

BIOLOGICAL

Nevirapine

Dosage

BIOLOGICAL

Atazanavir

Dosage

BIOLOGICAL

Darunavir

Dosage

BIOLOGICAL

Ritonavir

Dosage

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Marc TRELUYER · Assistance Publique - Hôpitaux de Paris

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2022-06-16
Completion
2022-06-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194165 on ClinicalTrials.gov