TABLE 2.
Pharmacokinetic profile of RTV in combination with IDV taken with a low-fat meal after 2 weeks of dosing and with a high-fat meal on day 15a
| IDV-RTV dose given q12h | n |
Cmax (mg/liter)
|
AUC24 (estimated) (mg · h/liter)
|
C12 (mg/liter)
|
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Low fat | High fat | GMR (95% CI) | Low fat | High fat | GMR (95% CI) | Low fat | High fat | GMR (95% CI) | ||
| 800-100 | 10 | 3.64 (2.81, 4.70) [2.55 to 5.68] | 2.07 (1.55, 2.76) [1.39 to 3.26] | 0.57 (0.47, 1.13) | 46.8 (68.8, 56.5) [30.8 to 63.0] | 31.9 (25.1, 40.5) [18.7 to 58.1] | 0.68 (0.60, 0.77) | 0.78 (0.52, 1.17) [0.36 to 1.33] | 0.76 (0.48, 1.20) [0.26 to 1.65] | 0.97 (0.79, 1.19) |
| Pbo-100 | 3 | 2.26 (1.28, 4.00) [1.56 to 3.21] | 0.78 (0.37, 1.63) [0.46 to 1.14] | 0.39, (0.18, 0.84) | 23.4 (11.1, 49.0) [16.6 to 42.6] | 11.9 (4.3, 33.0) [7.8 to 17.6] | 0.51 (0.31, 0.83) | 0.48 (0.20, 1.18) [0.30 to 0.65] | 0.35 (0.11, 1.13) [0.25 to 0.44] | 0.79 (0.59, 1.06) |
| 800-200 | 8 | 7.22 (5.48, 9.51) [3.27 to 12.65] | 6.18 (4.41, 8.65) [2.78 to 8.51] | 0.78 (0.59, 1.02) | 120.0 (94.3, 152.7) [47.9 to 158.5] | 98.9 (68.2, 143.5) [58.0 to 211.8] | 0.82 (0.70, 0.97) | 2.45 (1.59, 3.78) [0.90 to 4.75] | 2.78 (1.62, 4.76) [0.86 to 4.87] | 1.00 (0.81, 1.23) |
| Pbo-200 | 5 | 6.07 (3.89, 9.46) [3.97 to 9.20] | 3.67 (2.22, 6.04) [1.85 to 11.80] | 0.60 (0.33, 1.10) | 55.3 (33.8, 90.3) [31.6 to 78.9] | 41.3 (20.0, 85.1) [21.0 to 102.0] | 0.75 (0.44, 1.27) | 0.52 (0.24, 1.14) [0.26 to 0.91] | 0.53 (0.24, 1.17) [0.23 to 0.89] | 0.92 (0.85, 0.99) |
| 800-400 | 9 | 19.0 (14.46, 25.07) [8.06 to 32.60] | 13.8 (10.15, 18.84) [9.50 to 26.65] | 0.73 (0.48, 1.11) | 240.4 (186.9, 309.3) [132.1 to 300.9] | 225.1 (181.6, 279.0) [166.5 to 378.4] | 0.94 (0.71, 1.24) | 6.10 (3.95, 9.42) [3.28 to 18.21] | 5.79 (3.53, 9.50) [1.95 to 9.41] | 0.95 (0.66, 1.378) |
| 400-400 | 10 | 19.70 (15.25, 25.45) [12.15 to 38.16] | 14.42 (10.81, 19.22) [8.07 to 20.54] | 0.73 (0.60, 0.89) | 240.6 (179.6, 322.4) [119.7 to 435.0] | 199.0 (142.9, 277.1) [93.2 to 336.8] | 0.83 (0.70, 0.98) | 5.64 (3.76, 8.44) [1.09 to 11.38] | 4.39 (2.77, 6.96), [0.86 to 10.06] | 0.78 (0.57, 1.06) |
| Pbo-400 | 5 | 20.41 (13.09, 31.83) [10.69 to 29.77] | 14.77 (8.96, 24.34) [7.99 to 25.88] | 0.72 (0.46, 1.13) | 258.4 (158.0, 422.8) [150.6 to 416.2] | 207.9 (122.7, 352.3) [132.9 to 358.7] | 0.80 (0.60, 1.08) | 5.41 (2.68, 10.91) [3.31 to 13.07] | 4.65 [2.33 to 9.31] | 0.86 (0.61, 1.22) |
a
Data shown are ANOVA model-based geometric means (95% confidence intervals) [range]. GMR, geometric mean ratio; Pbo, IDV placebo. AUC24 was estimated as AUC0-τ × doses/day.