E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV infected children treated with darunavir |
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E.1.1.1 | Medical condition in easily understood language |
HIV infected children treated with darunavir |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068341 |
E.1.2 | Term | HIV-1 infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020161 |
E.1.2 | Term | HIV infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To validate FDA-approved dosing recommendation for once daily DRV/r in children 6-12 years old. This will be done by evaluating the pharmacokinetics of DRV/r given once daily (according to FDA dosing guideline) to children from 6 – 12 years |
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E.2.2 | Secondary objectives of the trial |
•To determine whether adequate exposure to DRV is attained when DRV/r is dosed once daily when compared to twice daily in children aged 6-12 years.
•To determine the safety of DRV/r once daily in children 6 – 12 years of age.
•Child and carers acceptability of once-daily DRV compared to alternative treatment regime at day of PK assessment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Area under the curve over one dosing interval (24 hours) of darunavir |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day of PK assessment (day 1) |
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E.5.2 | Secondary end point(s) |
1. Comparison target exposure in adults (geometric mean AUC0-24: 89.7 mg*h/L)
2. Explore, quantify and describe the occurrence of side effects of darunavir once daily
3. Explore acceptability of once-daily darunavir. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day of PK assessment (day 1) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Evaluable PK data of 12 subjects |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |