Table 1.
Baseline data and Week 2* LPV/r and RTV pharmacokinetic results for 9 infants with evaluable pharmacokinetic analysis.
| Variable | Baseline Data and Pharmacokinetic Results at Week 2 | |||||
|---|---|---|---|---|---|---|
| mean | median | SD | CV% | min | max | |
| Age at entry (weeks) | 5.4 | 5.7 | 0.8 | 14% | 3.6 | 5.9 |
| Weight (Kg) | 4.81 | 4.7 | 0.88 | 18% | 3.6 | 6.1 |
| BSA (m2) | 0.27 | 0.27 | 0.04 | 14% | 0.21 | 0.33 |
| Dose (mg) | 71.9 | 64 | 9.6 | 13% | 64 | 87 |
| LPV Predose Conc (mcg/mL) | 2.51 | 2.22 | 1.34 | 53% | 0.99 | 4.87 |
| LPV Maximum Conc (mcg/mL) | 5.17 | 4.76 | 1.84 | 36% | 2.84 | 7.28 |
| LPV AUC (mcg*h/mL) | 43.4 | 36.6 | 14.8 | 34% | 27.9 | 62.6 |
| RTV AUC (mcg*h/mL) | 1.60 | 1.25 | 1.29 | 81% | <0.6 | 4.78 |
| LPV CL/F (L/h/kg) | 0.43 | 0.37 | 0.22 | 50% | 0.15 | 0.75 |
| LPV CL/F (L/h/m2) | 7.56 | 6.75 | 3.54 | 47% | 2.79 | 12.83 |
| LPV Ka (h-1) | 0.47 | 0.34 | 0.32 | 70% | 0.19 | 1.21 |
| LPV V/F (L/kg) | 2.03 | 1.86 | 0.88 | 43% | 0.80 | 3.79 |
| LPV T1/2 (h) | 3.67 | 3.51 | 1.46 | 40% | 2.06 | 5.80 |
*
One subject had PK determination at week 8, after good adherence was assured
BSA: body surface area
LPV: lopinavir
RTV: ritonavir
CV: coefficient of variation
Cl/F: apparent clearance (adjusted for weight [kg] or body surface area [m2])
Ka: absorption rate constant
V/F: apparent volume of distribution
T1/2 half-life