TABLE 5.
Cmax, Tmax, and AUC at steady state for each drug, by study arm (n = 291)
| Drug and parameter at steady state | Median (minimum to maximum) for study arm: |
Estimated gradient (95% CI), P valuea | |
|---|---|---|---|
| Test (n = 144) | Control (n = 147) | ||
| Gatifloxacin | |||
| Cmax | 3.8 (2.5–5.8) | NAb | −3.82 (−11.78, 4.14), 0.34 |
| Tmax | 1.7 (0.8–3.6) | NA | NA |
| Ethambutol | |||
| Cmax | NA | 3.2 (1.5–5.5) | −1.99 (−5.96, 1.98), 0.32 |
| Tmax | NA | 2.5 (1.5–4.5) | NA |
| Isoniazid | |||
| Cmax | 3.1 (0.7–8.0) | 3.1 (0.5–6.0) | 0.86 (−1.11, 2.83), 0.39 |
| Tmax | 0.9 (0.6–3.2) | 0.8 (0.3–3.6) | NA |
| Rifampin | |||
| Cmax | 6.3 (1.4–13.2) | 6.9 (2.0–15.6) | 0.16 (−1.08, 1.39), 0.81 |
| Tmax | 2.2 (1.3–5.6) | 1.9 (1.1–5.3) | NA |
| Pyrazinamide | |||
| Cmax | 35.9 (23.8–60.4) | 35.0 (21.9–62.1) | −0.28 (−0.66, 0.10), 0.15 |
| Tmax | 1.7 (0.9–4.5) | 1.5 (0.8–5.0) | NA |
a
For the association of each drug Cmax individually on QTcF at month 1, adjusted for country, sex, age, and QTcF at enrollment, and study arm (only for isoniazid, rifampin, and pyrazinamide). CI confidence interval.
b
NA, not applicable.