Human Immunodeficiency VirusDAPHNENCT02285478
Pharmacokinetics of Once Daily Darunavir/Ritonavir in HIV-infected Children
An observational study of Human Immunodeficiency Virus and Children, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Human Immunodeficiency Virus, Children
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: HIV-infected children (6-12 years) using once daily darunavir/ritonavir.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Once Daily Darunavir/Ritonavir in HIV-infected Children 6-12 Years Old: a Pharmacokinetic Validation of Model Based Dosing Recommendations
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus, Children
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
The exposure of darunavir, compared to the target exposure (AUC0-24) in adults
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), UMC Utrecht
- Responsible party
- Sponsor
- Investigators
- David Burger, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285478
- Sponsor's protocol ID
- UMCN-AKF 13.03
- Acronym
- DAPHNE
- Status last verified
- Dec 2020
- First submitted
- 27 Oct 2014
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bastiaans DET, Geelen SPM, Visser EG, van der Flier M, Vermont CL, Colbers APH, Roukens M, Burger DM, van Rossum AMC; Dutch Paediatric HIV Study Group. Pharmacokinetics, Short-term Safety and Efficacy of the Approved Once-daily Darunavir/Ritonavir Dosing Regimen in HIV-infected Children. Pediatr Infect Dis J. 2018 Oct;37(10):1008-1010. doi: 10.1097/INF.0000000000001964.
PubMed 29474261
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once Daily Darunavir/Ritonavir in HIV-infected Children 6-12 Years Old: a Pharmacokinetic Validation of Model Based Dosing Recommendations
- ClinicalTrials.gov ID
- NCT02285478
- Acronym / sponsor ID
- DAPHNE / UMCN-AKF 13.03
- Conditions
- Human Immunodeficiency Virus, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), UMC Utrecht
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- HIV-infected children (6-12 years) using once daily darunavir/ritonavir.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The exposure of darunavir, compared to the target exposure (AUC0-24) in adults
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Results publication: PubMed 29474261Bastiaans DET, Geelen SPM, Visser EG, van der Flier M, Vermont CL, Colbers APH, Roukens M, Burger DM, van Rossum AMC; Dutch Paediatric HIV Study Group. Pharmacokinetics, Short-term Safety and Efficacy of the Approved Once-daily Darunavir/Ritonavir Dosing Regimen in HIV-infected Children. Pediatr Infect Dis J. 2018 Oct;37(10):1008-1010. doi: 10.1097/INF.0000000000001964.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Burger principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus and Children, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The exposure of darunavir, compared to the target exposure (AUC0-24) in adults (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02285478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.