Table 1.
Baseline characteristics of study participants
| Characteristic | Empiric (n=424) | IPT (n=426) | All Participants (n=850) |
|---|---|---|---|
| Male | 224 (53%) | 226 (53%) | 450 (53%) |
| Race | |||
| Black African or Black of African Origin | 380 (90%) | 388 (91%) | 768 (90%) |
| Others | 44 (10%) | 38 (9%) | 82 (10%) |
| Age (years) | 36 (30–42) | 35 (30–42) | 36 (30–42) |
| Country | |||
| Malawi | 95 (22%) | 98 (23%) | 193 (23%) |
| South Africa | 86 (20%) | 90 (21%) | 176 (21%) |
| Kenya | 77 (18%) | 75 (18%) | 152 (18%) |
| Haiti | 53 (13%) | 56 (13%) | 109 (13%) |
| Zimbabwe | 25 (6%) | 27 (6%) | 52 (6%) |
| Uganda | 25 (6%) | 24 (6%) | 49 (6%) |
| Peru | 20 (5%) | 19 (5%) | 39 (5%) |
| Zambia | 17 (4%) | 19 (5%) | 36 (4%) |
| India | 17 (4%) | 12 (3%) | 29 (3%) |
| Brazil | 9 (2%) | 6 (1%) | 15 (2%) |
| CD4 count (cells/mm3) | 18 (9–31) | 19 (9–33) | 18 (9–32) |
| HIV-1 RNA log10(cp/mL) | 5.4 (5.0–5.7) | 5.3 (4.9–5.7) | 5.3 (4.9–5.7) |
| Stratification Factors | |||
| < 25 CD4 count cells/mm3 | 253 (60%) | 257 (60%) | 510 (60%) |
| Hospitalized within the past 30 days | 19 (4%) | 23 (5%) | 42 (5%) |
| < 18.5 kg/m2 Body Mass Index | 120 (28%) | 128 (30%) | 248 (29%) |
| Anemia (hemoglobin <8 g/dl) | 28 (7%) | 16 (4%) | 44 (5%) |
| WHO stages * | |||
| No stages 3 or 4 event | 305 (72%) | 309 (73%) | 614 (72%) |
| Stage 3 | 85 (20%) | 77 (18%) | 162 (19%) |
| Stage 4 | 34 (8%) | 40 (9%) | 74 (9%) |
| Clinical Symptoms | |||
| Cough lasting for 2 or more weeks | 66 (16%) | 73 (17%) | 139 (16%) |
| Fever ≥38° Celsius | 27 (6%) | 22 (5%) | 49 (6%) |
| Hemoptysis in the past 2 weeks | 0 (0%) | 1 (<1%) | 1 (<1%) |
| Night sweats in the past 2 weeks | 32 (8%) | 43 (10%) | 75 (9%) |
| Unintentional weight loss in the past 30 days | 195 (46%) | 220 (52%) | 415 (49%) |
| Enlarged axillary or cervical lymph nodes | 38 (9%) | 43 (10%) | 81 (10%) |
| At least one TB symptom reported | 237 (56%) | 265 (62%) | 502 (59%) |
Data are n(%) or median (IQR).
*
Number of participants who had at least one event at baseline.