To validate FDA-approved dosing recommendation for once daily darunavir/ritonavir in children 6-12 years old
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Area under the plasma concentration time profile (AUC) for a dose interval of
24 hours
Secondary outcome
- Ratio of the AUC and other pharmacokinetic parameters after once daily,
compared to twice daily dosing.
- Safety of darunavir once daily
- Acceptability of once daily darunavir compared to previous treatment regime
Background summary
Adherence is crucial for a successful antiretroviral treatment. Less
complicated therapy, such as once daily regimens, and less toxic drugs, can
improve short and long-term outcomes for HIV-infected children. Dyslipidemia is
an adverse effect that is associated with the use of antiretroviral drugs,
including all PIs (especially PIs combined with ritonavir as booster). There
are indications that within the class of PIs DRV might have more beneficial
toxicity profiles, regarding its effects on lipid profile (mainly
triglycerides) than other PIs. Together with the potential for once daily
dosing, HIV-infected children could benefit from treatment with DRV/r once
daily compared to treatment with other PIs.
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
recently 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 objective
To validate FDA-approved dosing recommendation for once daily
darunavir/ritonavir in children 6-12 years old
Study design
Multi-center, phase I, pharmacokinetic trial
Study burden and risks
The risk-classification is assessed as negligible to the patient population
receiving study drug at the current regimens. The drug (darunavir) is licensed
by the FDA for the use as investigated in this protocol.
A rich sampling pharmacokinetic assessment, performed after switch to a
once-daily regime, is part of current routine clinical practice for children
who are treated with a antiretroviral drugs.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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 not older 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
8. Acute illness
9. Receiving concomitant therapy except for prophylaxis for opportunistic infections.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-001111-39-NL |
| CCMO | NL48775.091.14 |