Table 1.
Patient demographics, covariates and study designs of the clinical studies contributing data to the isoniazid pharmacokinetic model. Continuous variables are given as median (95% range)
| DPM | BKH | Combined | |
|---|---|---|---|
| Subjects | 91 | 144 | 235 |
| Age (years) | 37 (23–60) | 36 (20–60) | 36 (20–60) |
| Gender (female/male) | 24/67 | 78/66 | 102/133 |
| Race (Coloured / Black / Caucasian) | 64/25/2 | 128/16/0 | 192/41/2 |
| Weight (kg) | 52.5 (37.5–66.9) | 46.1 (31.2–68.0) | 48.0 (33.7–68.0) |
| Dose (mg kg−1) | 5.11 (3.98–6.90) | 6.51 (4.41–9.59) | 5.88 (4.28–8.92) |
| BMI (kg m–2) | 19.6 (15.6–24.5) | 17.8 (13.1–23.7) | 18.5 (13.3–24.4) |
| HIV infection* | 21 (24.1% of 87) | 14 (9.79% of 143) | 35 (15.2% of 230) |
| Formulation (fixed-dose combination / single drug) | 89/2 | 34/110 | 123/112 |
| Study length (weeks) | 2 | 1 | |
| Samples/subject | 12 | 9 | 2352† |
| 3 per day, twice per week | during a single day | ||
| Sampling schedule | Pre-dose and random between 0–12 h post-dose | Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 h post-dose | |
| Dosing (mg day−1, p.o.) | 100 (n = 1); 225 (n = 8); 240 (n = 29); 300 | 200 (n = 1); 300 (n = 142); 450 (n = 1) – 7 days per week | |
| (n = 53); 400 (n = 2) – 5 days per week |
*
n = 230 subjects; five patients declined to be tested.
†
Total number of samples.