Table 1.
Overview of the datasets used to adjust the darunavir population pharmacokinetic model
| Dataset | DUET-1 and DUET-2 | DELPHI | ARIEL | ARIEL substudy | DIONE |
|---|---|---|---|---|---|
| Patients (n) | 30 | 41 | 24 | 10* | 12 |
| Dose of darunavir/ritonavir | 600/100 mg BID | 300–600/50–100 mg BID | 20/3 mg/kg BID | 40/7 mg/kg QD for <15 kg | 800/100 mg QD |
| 600/100 mg BID for ≥15 kg | |||||
| Age range (years) | 18–66 | 6–17 | 3–5 | 3–5 | 12–17 |
| Bodyweight, range (kg) | 45–96 | 20–49 | 12–19 | 13–19 | 40–62 |
| AAG, range (mg/dL) | 54–347 | 48–312 | 63–156 | 56–125 | 52–120 |
| Samples per patient (n) | 8 | 5 | 5 | 6 | 6 |
| Time, range (h) | 0–12 | 0–12 | 0–12 | 0–24 | 0–24 |
| Darunavir formulation | Tablets 300 mg | Tablets 300 mg & 75 mg | Suspension 100 mg/mL | Suspension 100 mg/mL | Tablets 400 mg |
*
The 10 patients in the ARIEL QD substudy are also included in the 24 patients of the main ARIEL BID study.