Table 2. PK parameters for ARM, DHA, and LR after administration of AL in HIV-infected children on NVP compared to HIV-uninfected children (historical controls).
| AL+NVP | AL (controls) | Difference | |
|---|---|---|---|
| n = 15 | n = 20* | % (p-value) | |
| ARM | |||
| Cmax (ng/mL) | 17.2 (9.9 to 29.9) | 34.4 (27.1 to 43.8) | -50.0 (0.07) |
| Tmax (hr) | 1.3 (1.0 to 4.0) | 2.0 (1.8 to 8.0) | -35 (0.028) |
| AUC0-8hr (hr•ng/mL) | 65.9 (38.1 to 114) | 123 (99.2 to 153) | -46.4 (0.08) |
| DHA | |||
| Cmax (ng/mL) | 76.5 (57.6 to 101.4) | 119 (96.7 to 147) | -35.7 (0.01) |
| Tmax (hr) | 2.0 (1.0 to 4.0) | 2.0 (1.8 to 8.0) | 0.0 (0.12) |
| AUC0-8hr (hr•ng/mL) | 261 (206 to 330) | 336 (279 to 404) | -22.3 (0.06) |
| LR | |||
| Cmax (μg/mL) | 13.2 (10.3 to 17.0) | 6.76 (5.36 to 8.52) | 95.3 (<0.001) |
| Tmax (hr) | 2.0 (0.0 to 8.0) | 4.0 (0.0 to 24.2) | -50.0 (0.96) |
| AUC0-120hr (hr•μg/mL) | 435 (333 to 569) | 195 (150 to 253) | 123 (<0.001) |
| Cday7 (ng/mL) | 697 (155 to 2250) | 323 (53.9 to 779) | 116 (<0.001) |
AUC and Cmax summarized using geometric means (95% confidence intervals)
Tmax and Cday7 summarized using medians (range).
Statistical comparisons between groups from Wilcoxon rank sum tests