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Pharmacokinetics of Once Daily Darunavir/Ritonavir in HIV-infected Children

NCT02285478 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2020-12-07

No results posted yet for this study

Summary

Darunavir/ritonavir is one of the preferred antiretroviral agents as part of combination antiretroviral therapy for treatment of HIV-infected adults according to international guidelines. For children 3-12 years old, FDA has approved once daily dosing of darunavir/ritonavir. Dosing recommendations for children 6-12 years old have been approved based on a modelling and simulation procedure by the company.

This pharmacokinetic study is designed to validate the proposed dosing recommendation for once daily darunavir/ritonavir in HIV-infected children aged 6-12 years old.

Conditions

  • Human Immunodeficiency Virus
  • Children

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • David Burger · Radboud University Medical Center

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

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 NCT02285478 on ClinicalTrials.gov