Table 1.
Summary of study and subject demographicsa
| Study | No. of NVP subjects | Study location | NVP maintenance dose (mg/m2) | Median no. of samples per subject (range) | Median age (yr) at PK visits (range) | No. of doses in formulationb | Median wt (kg) at PK visits (range) | Total no. of samples |
|---|---|---|---|---|---|---|---|---|
| 245, phase I | 238 | U.S. | 120 | 3 (1–6) | 7.3 (1.2–19.5) | 521 liquid | 21.8 (7.0–61.9) | 693 |
| 356, phase I/II | 54 | U.S. | 200 | 6.5 (1–16) | 0.3 (0.1–2.1) | 144 liquid | 5.9 (2.8–16.2) | 376 |
| 366, phase I/II | 85 | U.S. | 120 | 3 (1–9) | 5.9 (0.6–17.2) | 168 liquid, 13 tablet | 19.5 (8.4–64.6) | 305 |
| 377, phase I/II | 102 | U.S. | 120 | 6 (1–20) | 6.0 (0.5–14.7) | 248 liquid, 38 tablet | 20.9 (5.5–73.8) | 698 |
| 403, phase II | 16 | U.S. | 120 | 6 (1–12) | 6.3 (0.5–19.3) | 17 liquid, 7 tablet | 22.7 (9.2–56.5) | 91 |
| CHAPAS, phase I/II | 59 | Zambia | 150–200 | 7 (7–7) | 6.9 (0.6–13.6) | 59 Triomune | 16.0 (3.4–29.0) | 413 |
| P1056, phase I/II | 43 | Thailand | 120–200 | 14 (12–16) | 8.3 (0.7–12.0) | 43 liquid, 43 GPO-VIR | 21.0 (6.4–28.9) | 602 |
| P1069, phase I/II | 42 | Thailand | 150–200 | 14 (7–14) | 6.1 (0.5–12.3) | 41 liquid, 42 GPO-VIR | 19.1 (5.9–28.6) | 581 |
| Overall | 639 | 4 (1–20) | 6.5 (0.1–19.5) | 1,182 liquid, 58 tablet, 85 GPO-VIR, 59 Triomune | 19.7 (2.8–73.8) | 3,759 |
a
Age and weight are representative of the first PK visit.
b
“Tablet” refers to the Boehringer Ingelheim tablet; GPO-VIR and Triomune are fixed-dose combination tablets. The maximum dose was 200 mg.