TABLE 2.
Pharmacokinetic parameters for indinavir and low-dose ritonavir for 14 children in this study and comparisons with those for historical controlsa
| Value | Value for parameter:
|
|||
|---|---|---|---|---|
| AUC0-24 | Cmax | Cmin | Tmax | |
| Indinavir | ||||
| Geometric mean for 14 patients in this study | 92.9 (75.4-114.5) | 8.6 (7.3-10.1) | 0.63 (0.40-1.0) | 2.8 (1.8-3.1) |
| GMR of parameter for this study to that for two previous protocolsb | 1.8 (1.5-2.3)* | 1.1 (0.97-1.4) | 8.4 (5.3-13.4)* | NA |
| GMR of parameter for this study to that for Merck protocol 021c | 1.8 (1.4-2.2)* | 1.2 (0.99-1.4) | 4.9 (3.1-7.9)* | NA |
| GMR of parameter for this study to that for a previous studyd | 1.1 (0.87-1.3) | 0.80 (0.68-0.94)* | 0.96 (0.60-1.5) | ND |
| Ritonavir | ||||
| Geometric mean for 14 patients in this study | 76.8 (61.0-96.7) | 6.0 (4.7-7.8) | 1.1 (0.84-1.6) | 3.6 (1.5-4.2) |
| GMR of parameter for this study to that for a previous studyd | 3.8 (3.0-4.8)* | 2.9 (2.2-3.7)* | 3.2 (2.4-4.3)* | ND |
a
For AUC0-24, Cmax, and Cmin, ranges in parentheses are 90% confidence intervals; for Tmax (time to minimum concentration of drug in serum), ranges in parentheses are interquartile ranges. GMR, geometric mean ratio; NA, not available; ND, not determined; *, statistically significant.
b
Combined protocols Merck 068 and PACTG395, involving 500 mg of indinavir/m2 q8h in children.
c
Merck protocol 021 involved 800 mg of indinavir q8h in adults.
d
The study by Arnaiz et al. (2), involving 800 mg of indinavir plus 100 mg of ritonavir q12h in adults.