Table 1.
Baseline Characteristics of Participants by Human Immunodeficiency Virus Status
| Characteristic | Diagnosed with HIV (n = 127) |
Not Diagnosed with HIV (n = 1077) |
Total (n = 1204) |
P Valuea |
|---|---|---|---|---|
| Age, y | 3.6 (1.2, 10.3) | 3.5 (1.5, 6.9) | 3.5 (1.5,7.0) | .07 |
| Female | 63 (49.6) | 520 (48.3) | 583 (48.4) | .78 |
| Weight-for-age zscore | −2.3 (−3.3, −0.8) | −1.0 (−1.8, −0.2) | −1.0 (−1.9, 0.3) | <.01 (t test) |
| Hemoglobin count, g/dL | 9.5 (8.7, 10.9) | 11.5 (10.4, 12.3) | 11.3 (10.1, 12.2) | <.01 (t test) |
| Alanine aminotransferase | 20.2 (13.8, 35.2) | 15.0 (12.0, 20.8) | 15.7 (12.0, 21.4) | <.01 (t test) |
| Site of disease,b n (%) | ||||
| Pulmonary only | 74 (58.3) | 730 (67.8) | 804 (66.8) | <.01 |
| Pulmonary and lymph node | 53 (41.7) | 300 (27.9) | 353 (29.3) | … |
| Lymph node only | 0 (0) | 40 (3.7) | 40 (3.3) | … |
| Other | 0 (0) | 7 (0.7) | 7 (0.6) | … |
| TB status | ||||
| Bacteriologically confirmed | 8 (6.3) | 157 (14.6) | 165 (13.7) | .01 |
| Unconfirmed | 95 (74.8) | 698 (64.1) | 1039 (65.9) | … |
| Unlikely | 24 (18.9) | 222 (20.6) | 246 (20.4) | … |
| Anti-TB drug dosing weight band, kg | ||||
| 3.0 ≤ 3.9 | 2 (1.6) | 1 (0.1) | 3 (0.3) | <.01 |
| 4.0 ≤ 7.9 | 35 (27.6) | 145 (13.5) | 180 (15.0) | … |
| 8.0 ≤ 11.9 | 29 (22.8) | 284 (26.4) | 313 (26.0) | … |
| 12.0 ≤ 15.9 | 10 (7.9) | 231 (21.5) | 241 (20.0) | … |
| 16.0 ≤ 24.9 | 31 (24.4) | 266 (24.7) | 297 (24.7) | … |
| ≥25.0 | 20 (15.8) | 150 (13.9) | 170 (14.1) | … |
| Site/Country | ||||
| Zambia | 91 (71.6) | 273 (25.3) | 364 (30.2) | <.001 |
| Uganda | 31 (24.4) | 345 (32.0) | 376 (31.2) | … |
| South Africa | 5 (3.9) | 310 (28.8) | 315 (26.2) | … |
| India | 0 (0) | 149 (13.8) | 149 (12.4) | … |
| Randomization arm | ||||
| 4 m | 65 (51.2) | 537 (49.9) | 602 (50.0) | … |
| 6 m | 62 (48.8) | 540 (50.1) | 602 (50.0) | … |
Data presented as number of participants (%) or median (interquartile range).
Abbreviations: HIV, human immunodeficiency virus; TB, tuberculosis.
a P value from χ2 test unless otherwise stated.
bIntrathoracic lymph node was classified as pulmonary TB; peripheral lymph node disease without any respiratory symptoms or abnormal chest X-ray findings was classified as lymph node disease.