HIV infected children treated with darunavir MedDRA version: 19.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Prezista
Pharmaceutical Form: Tablet
INN or Proposed INN: DARUNAVIR
CAS Number: 206361-99-1
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 600-800
Sponsors
Radboud University Nijmegen Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: •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. ;Primary end point(s): Area under the curve over one dosing interval (24 hours) of darunavir;Timepoint(s) of evaluation of this end point: Day of PK assessment (day 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: Day of PK assessment (day 1) | — |
Countries
Netherlands
Contacts
Public ContactDiane Bastiaans
Radboud University Medical Center
Outcome results
None listed