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

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02285478
Collaborator
Erasmus Medical Center (Other), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other), UMC Utrecht (Other)
12
Enrollment
1
Location
16
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The EMA and FDA recommended weight band dosing for once daily DRV/r dosing in children 3 -12 years of age has been derived from pharmacokinetic modelling. Results from population pharmacokinetic modelling and simulation in these children predict similar DRV plasma exposures compared to treatment-naïve adults, but has not been formally studied in the target population. Although no clinical trial was conducted to collect exposure-safety data, the predicted exposures from the once daily dosing is supported by exposures observed in a paediatric clinical trial where twice-daily dosing was administered. To validate the weight band based dosing recommendations, we want to evaluate the pharmacokinetics of DRV/r administered once daily, using DRV tablets, in HIV-infected children.

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    12 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Once Daily Darunavir/Ritonavir in HIV-infected Children 6-12 Years Old: a Pharmacokinetic Validation of Model Based Dosing Recommendations
    Study Start Date :
    Mar 1, 2015
    Actual Primary Completion Date :
    Jul 1, 2016
    Actual Study Completion Date :
    Jul 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. The exposure of darunavir, compared to the target exposure (AUC0-24) in adults [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Parents/carers are able and willing to sign the informed consent form prior to screening evaluations

    2. Subject is HIV infected

    3. Subject is at least 6 and less than 12 years at day of screening

    4. Subject has a body weight of at least 15kg

    5. Subject is able to swallow tablets

    6. Subject has an undetectable viral load (<50 copies/mL) for the last 6 months prior to screening (at least 2 measurements)

    7. ART regimen consists of darunavir/ritonavir and 2 NRTIs

    Exclusion Criteria:

    1. Inability to understand the nature and extent of the trial and the procedures required

    2. Documented history of sensitivity/idiosyncrasy to darunavir or ritonavir medicinal products or its excipients

    3. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion

    4. Abnormal renal or liver function (grade 3 or above)

    5. Participation in a drug trial within 60 days prior to the first dose

    6. Hemoglobin < 10 g/dL (6.0 mmol/L)

    7. Children who have previously failed virologically on a PI containing regimen (where virological failure is defined as two successive HIV-1 RNA results >1,000 c/mL more than 24 weeks after starting cART, i.e. changes for toxicity or convenience are not counted as failure)

    8. Acute illness

    9. Receiving concomitant therapy except for prophylaxis for opportunistic infections; some treatments may be allowed, but must first be discussed with the principal investigator or project manager.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboud University Medical Center Nijmegen Netherlands

    Sponsors and Collaborators

    • Radboud University Medical Center
    • Erasmus Medical Center
    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    • UMC Utrecht

    Investigators

    • Principal Investigator: David Burger, Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02285478
    Other Study ID Numbers:
    • UMCN-AKF 13.03
    First Posted:
    Nov 7, 2014
    Last Update Posted:
    Dec 7, 2020
    Last Verified:
    Dec 1, 2020
    Additional relevant MeSH terms:
    Acquired Immunodeficiency Syndrome
    HIV Infections

    Study Results

    No Results Posted as of Dec 7, 2020