TABLE 1.
Clinical characteristics of the cohort, stratified by HIV-1 serostatus
| Clinical characteristica | Value |
||
|---|---|---|---|
| Whole PK cohort (n = 100) | HIV-1-infected patients (n = 65) | HIV-1-uninfected patients (n = 35) | |
| Male (no. [%]) | 57 (57) | 30 (46) | 27 (77) |
| Xhosa ethnicity (no. [%]) | 98 (98) | 63 (97) | 35 (100) |
| Median (IQR) age (yr) | 33 (29–40) | 34 (30–40) | 32 (27–38) |
| No. (%) of patients with smoking history | |||
| Current | 24 (24) | 9 (14) | 15 (43) |
| Previous | 27 (27) | 19 (29) | 8 (23) |
| Never | 49 (49) | 37 (57) | 12 (34) |
| No. (%) of patients with characteristic | |||
| Alcohol consumption | 37 (37) | 16 (25) | 17 (49) |
| Recreational drug use | 5 (5) | 3 (5) | 2 (6) |
| Previously in prison | 14 (14) | 10 (15) | 4 (11) |
| Previous mining history | 5 (5) | 1 (1) | 4 (11) |
| Retreatment | 39 (39) | 29 (45) | 10 (29) |
| Type 2 diabetes mellitus | 4 (4) | 3 (5) | 1 (3) |
| Median (IQR) BMI at baseline (kg/m2) | 21 (19–23) | 21 (20–23) | 20 (19–23) |
| Median (IQR) BMI at PK study (kg/m2) | 21.5 (20–23) | 22 (20–23) | 20.5 (19–23) |
| Median (IQR) FFM at PK study (kg) | 45 (38–49) | 40.5 (36–47) | 49 (46–51) |
| Median (IQR) CD4 count (cells/mm3) | 233 (106–386) | ||
| No. (%) with viral load of <40 copies/ml at baseline | 17 (26) | ||
| Median (IQR) albumin concn at PK study (g/liter) | 38 (34–40) | 36 (34–39) | 38 (40–43) |
| Median (IQR) total protein concn at PK study (g/liter) | 86 (79–92) | 88 (82–93) | 82 (75–86) |
| Median (IQR) time on ART at time of PK study (mo) | 1.32 (0–15.5) | ||
| No. (%) of patients with smear grade at baseline | |||
| 3+ | 24 (24) | 14 (21.5) | 10 (29) |
| 2+ | 22 (22) | 11 (17) | 11 (31) |
| 1+ | 20 (20) | 14 (21.5) | 6 (17) |
| Scanty/negative | 34 (34) | 26 (40) | 8 (23) |
| Median (IQR) baseline time to culture positivity (days) | 10 (7–14) | 12 (7–15) | 8 (6.5–12.5) |
| No. (%) of patients with extensive radiological disease at baseline | 71 (71) | 41 (63) | 30 (86) |
| No. (%) of patients with cavities at baseline | 52 (52) | 32 (49) | 20 (57) |
| Median (range) dose at PK study (mg/kg) | |||
| Rifampin | 10 (7–11.5) | 10 (7–11.5) | 10 (7–11.5) |
| Isoniazid | 5 (3.5–6) | 5 (4–6) | 5 (3.5–6) |
| Pyrazinamide | 26 (19–31) | 26 (20–31) | 25.5 (19–31) |
| No. (%) of patients with side effects of TB treatment | 35 (35) | 25 (38) | 10 (29) |
| No. (%) of poorly adherent patients per pill counts/self-reports at 2-month review | 10 (10) | 8 (12) | 2 (6) |
a
Characteristics are reported for the time of diagnosis (baseline) unless otherwise specified (at PK visit or 2-month visit). Abbreviations: BMI, body mass index; FFM, fat-free mass; ART, antiretroviral therapy; PK, pharmacokinetics.