Status:
COMPLETED
Pharmacokinetics of Once Daily Darunavir/Ritonavir in HIV-infected Children
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Human Immunodeficiency Virus
Children
Eligibility:
All Genders
6-12 years
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...
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 model...
Eligibility Criteria
Inclusion
- Parents/carers are able and willing to sign the informed consent form prior to screening evaluations
- Subject is HIV infected
- Subject is at least 6 and less than 12 years at day of screening
- Subject has a body weight of at least 15kg
- Subject is able to swallow tablets
- Subject has an undetectable viral load (\<50 copies/mL) for the last 6 months prior to screening (at least 2 measurements)
- ART regimen consists of darunavir/ritonavir and 2 NRTIs
Exclusion
- Inability to understand the nature and extent of the trial and the procedures required
- Documented history of sensitivity/idiosyncrasy to darunavir or ritonavir medicinal products or its excipients
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion
- Abnormal renal or liver function (grade 3 or above)
- Participation in a drug trial within 60 days prior to the first dose
- Hemoglobin \< 10 g/dL (6.0 mmol/L)
- 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)
- Acute illness
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02285478
Start Date
March 1 2015
End Date
July 1 2016
Last Update
December 7 2020
Active Locations (1)
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1
Radboud University Medical Center
Nijmegen, Netherlands