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| Age | Cohort | RAL Formulation | Number of Participants with Intensive PK Data | Mean Dose of RAL (mg/kg) | GM AUC0-12h µM·h (CV%)a |
GM C12h nM (CV%)b |
|---|---|---|---|---|---|---|
| 12 Years to <19 Years | I | Film-coated tablet | 11 | 9.3 | 15.7 (98%) | 333 (78%) |
| 6 Years to <12 Years | IIA | Film-coated tablet | 11 | 13.5 | 15.8 (120%) | 246 (221%) |
| 6 Years to <12 Years | IIB | Chewable tablet | 10 | 6.5 | 22.6 (34%) | 130 (88%) |
| 2 Years to <6 Years | III | Chewable tablet | 12 | 6.2 | 18.0 (59%) | 71 (55%) |
| 6 Months to <2 Years | IV | Oral suspension | 8 | 5.9 | 19.8 (34%) | 108 (52%) |
| 4 Weeks to <6 Months | V | Oral suspension | 11 | 5.7 | 22.3 (40%) | 117 (68%) |
| a PK targets for Cohorts I–III: AUC0-12h 14–25 µM·h (6–11 mg·h/L); C12h nM ≥33 nM (14.7 ng/mL) b PK targets for Cohorts IV–V: AUC0-12h 14–45 µM·h (6–20 mg·h/L); C12h nM ≥75 nM (33.3 ng/mL) Key: AUC = area under the curve; C12h = concentration at 12 hours (trough); CV = coefficient of variation; GM = geometric mean; PK = pharmacokinetic; RAL = raltegravir |
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