TABLE 1.
Baseline characteristicsa
| Parameter | Value for group |
P value | ||
|---|---|---|---|---|
| Oral 10 mg/kg (n = 17) | Oral 35 mg/kg (n = 15) | i.v. 20 mg/kg (n = 14) | ||
| Median age (yrs) (IQR) | 38 (34–47) | 41 (36–45) | 37 (30–43) | 0.26 |
| % (no.) of female participants | 47 (8) | 33 (5) | 50 (7) | 0.62 |
| % (no.) of participants of ethnicityb | 0.26 | |||
| African | 82 (14) | 80 (12) | 93 (13) | |
| Caucasian | 12 (2) | 0 | 0 | |
| Mixed race | 6 (1) | 20 (3) | 7 (1) | |
| Median wt (kg) (IQR) | 64 (54–77) | 60 (53–80) | 59 (54–62) | 0.67 |
| Median BMI (kg/m2) (IQR) | 25 (22–32) | 22 (20–23) | 22 (19–23) | 0.08 |
| Median CD4 count (cells/μl) (IQR) | 130 (64–253) | 131 (45–204) | 145 (96–333) | 0.43 |
| % (no.) of patients with ART status | 0.42 | |||
| On ART | 29 (5) | 27 (4) | 36 (5) | |
| ART naive | 53 (9) | 27 (4) | 36 (5) | |
| Previous ART | 18 (3) | 47 (7) | 29 (4) | |
| % (no.) of patients with TBM diagnosis | 0.65 | |||
| Definite TBM | 41 (7) | 27 (4) | 29 (4) | |
| Possible TBM | 29 (5) | 53 (8) | 36 (5) | |
| Probable TBM | 29 (5) | 20 (3) | 36 (5) | |
| % (no.) of patients with MRC grade | 0.59 | |||
| Grade 1 | 59 (10) | 53 (8) | 71 (10) | |
| Grade 2 | 41 (7) | 47 (7) | 29 (4) | |
| Grade 3 | 0 | 0 | 0 | |
| Modified Rankin score (IQR) | 3 (1–5) | 3 (1–5) | 3 (1–4) | 0.95 |
| Median duration of TB treatment before PK visit (days) (IQR)c | 5 (4–6) | 5 (3–6) | 6 (4–7) | 0.65 |
| Median total rifampicin dose (mg) (IQR) | 600 (450–750) | 2,100 (1,800–2,700) | 1,350 (1,200–1,350) | <0.001 |
| Median rifampicin dose (mg/kg) (IQR) | 9 (8–10) | 34 (33–36) | 22 (22–24) | <0.001 |
a
ART, antiretroviral therapy; BMI, body mass index; MRC, British Medical Research Council.
b
Self-reported.
c
Participants were allowed to receive up to 5 days of TB treatment prior to trial enrollment.