TABLE 5.
Pharmacokinetics of stavudine in pediatric and adult patients with HIV infection following oral administration of various doses
| Patient population | Total dose (mg/kg/day [regimen]) | Median [mean (SD)] pharmacokinetic parameter valuesa
|
Median [mean (SD)] pharmacokinetic parameter valuesa
|
||||||
|---|---|---|---|---|---|---|---|---|---|
| Single dose
|
Steady state
|
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| Cmax (ng/ml) | AUC0–∞ (ng · h/ml) | CL/Fb (ml/min) | t1/2 (h) | Cmax (ng/ml) | AUCτ (ng · h/ml) | CL/F (ml/min) | t1/2 (h) | ||
| Children | 1.0 (0.5 mg/kg) | 333 (353 [104]) (n = 8) | 671 (642 [231]) (n = 8) | 181 (196 [103]) (n = 8) | 0.90 (0.90 [0.28]) (n = 8) | 385 (424 [189]) (n = 8) | 672 (631 [237]) (n = 8) | 176 (198 [109]) (n = 8) | 1.07 (1.10 [0.23]) (n = 8) |
| 2.0 (1.0 mg/kg) | 692 (743 [146]) (n = 5c) | 1,063 (1,270 [467]) (n = 5) | 258 (265 [83]) (n = 5) | 0.96 (0.96 [0.16]) (n = 5) | 845 (956 [612]) (n = 8) | 1,436 (1,439 [521]) (n = 8) | 212 (233 [109]) (n = 8) | 1.04 (1.06 [0.16]) (n = 8) | |
| Adults | 0.5 (0.25 mg/kg) | 414 (385 [140]) (n = 5) | 484 (472 [52]) (n = 5) | 689 (714 [86]) (n = 5) | 1.28 (1.24 [0.17]) (n = 5) | 356 (310 [92]) (n = 4d) | 538 (565 [103]) (n = 4) | 620 (604 [99]) (n = 4) | 1.07 (1.27 [0.54]) (n = 4) |
| 1.0 (0.5 mg/kg) | 771 (720 [324]) (n = 9d) | 1,201 (1,073 [414]) (n = 9) | 555 (659 [326]) (n = 9) | 1.39 (1.33 [0.40]) (n = 9) | 689 (857 [606]) (n = 10) | 1,194 (1,173 [370]) (n = 10) | 539 (574 [150]) (n = 10) | 1.32 (1.45 [0.44]) (n = 10) | |
a
Single-dose pharmacokinetic parameters were derived after administration of the first oral dose; steady-state pharmacokinetic parameters were derived for adults after at least 6 days of oral dosing and for children after at least 12 weeks of dosing. n, number of patients.
b
F, bioavailability.
c
Data were not available for three patients.
d
Data were not available for one patient.