TABLE 1.
Stage II Stavudine (d4T), lamivudine (3TC), and Nevirapine (NVP) Pharmacokinetic Parameters After Ingestion of GPO-VIR S7 or the Individual Liquid Formulations (Geometric Means and 90% CI) in HIV-infected Thai Children
All Weight Groups (N=34) |
GMR (90%CI)‡ GPO-VIR S7/ Liquid |
|||
---|---|---|---|---|
GPO-VIR S7* | Liquid* | P† | ||
d4T§ | ||||
AUC (μg h/mL) | 1.54¶ (1.42–1.67) | 1.59¶ (1.49–1.71) | 0.25 | 0.97¶ (0.92–1.02) |
Cmax (μg/mL) | 0.94¶ (0.84–1.05) | 0.87¶ (0.79–0.95) | 0.21 | 1.08¶ (0.97–1.20) |
3TC | ||||
AUC (μg hr/mL) | 6.39¶ (5.82–7.00) | 4.52¶ (4.14–4.94) | <0.0001 ¶ | 1.41¶ (1.30–1.53) |
Cmax (μg/mL) | 2.16¶ (1.90–2.45) | 1.35¶ (1.23–1.50) | <0.0001 ¶ | 1.59¶ (1.39–1.82) |
Cmin (μg/mL) | 0.07¶ (0.06–0.07) | 0.07¶ (0.06–0.07) | 0.69 | 0.98¶ (0.90–1.06) |
NVP | ||||
AUC (μg h/mL) | 74.06¶ (65.62–83.60) | 68.40¶ (61.36–76.25) | 0.005 ¶ | 1.08¶ (1.04–1.13) |
Cmax (μg/mL) | 7.80¶ (7.01–8.67) | 6.86¶ (6.20–7.58) | <0.0001 ¶ | 1.14¶ (1.08–1.19) |
Cmin (μg/mL) | 4.68¶ (4.04–5.43) | 4.48¶ (3.94–5.10) | 0.21 | 1.05¶ (0.99–1.11) |
Reported values are geometric mean (90% CI).
The p values are from paired t tests comparing the 2 formulations.
GMR (90%): Geometric mean ratio and 90% confidence interval.
d4T Cmin was below lower limit of assay quantification (<0.025 μg/mL) over all weight groups.
P < 0.05 are bolded.