Table 1.
Parametera | Result formatb | Value for regimenc |
||
---|---|---|---|---|
Raltegravir at 400 mg BID (n = 19) | Raltegravir at 800 mg QD (n = 19) | Raltegravir at 400 mg QD (n = 17) | ||
AUC (h-mg/liter) | Geometric mean (%CV) | 13.0 (76.2) | 29.8 (50.8) | 16.1 (60.3)** |
Mean (SD) | 15.6 (8.8) | 33.6 (19.3) | 18.6 (10.8) | |
Half-life (h) | Geometric mean (%CV) | 2.6 (67.4) | 5.8 (45.9)** | 4.8 (35.5)** |
Mean (SD) | 3.1 (2.1) | 6.3 (2.7) | 5.0 (1.8) | |
Clearance (liters/h) | Geometric mean (%CV) | 30.9 (76.2) | 24.8 (60.3) | 26.8 (50.8)* |
Mean (SD) | 39.0 (30.1) | 29.7 (13.8) | 28.7 (16.8) | |
Cmax (mg/liter) | Geometric mean (%CV) | 4.5 (116.6) | 10.2 (65.5)** | 5.59 (83.4) |
Mean (SD) | 6.1 (3.9) | 11.9 (6.4) | 6.7 (3.5) | |
Ctrough (mg/liter) | Geometric mean (%CV) | 0.14 (125.4) | 0.03 (169.9)** | 0.05 (69.2)** |
Mean (SD) | 0.22 (0.24) | 0.06 (0.04) | 0.08 (0.19) | |
Tmax (h) | Median (IQR) | 1.5 (1.5–6) | 2 (1–2.5) | 2 (1–3) |
The AUC for twice-daily (BID) dosing is the AUC0-12; the AUC for once-daily (QD) dosing is the AUC0-24. Statistical comparisons of AUC were performed against the calculated AUC0-24 for dosing at 400 mg BID (i.e., 26 h-mg/liter). The Ctrough for BID dosing is the C12, and that for QD dosing is the C24.
CV, coefficient of variance; SD, standard deviation; IQR, interquartile range.
Statistical comparisons were made for geometric mean values, using paired data.
, P < 0.05;
, P < 0.001.