TABLE 1.
Baseline characteristics and participants developing tuberculosis-associated immune reconstitution inflammatory syndrome (TB-IRIS) and receiving prednisone as treatment according to trial arm
| Prednisone | Placebo | |
| Male | 49 (64) | 41 (54) |
| Age years | 38 (31–43) | 38 (31–44) |
| CD4 count cells·μL−1 | 46 (24–81) | 50 (24–86) |
| HIV viral load log10 copies·mL−1 | 5.5 (5.2–5.8) | 5.6 (5.3–5.9) |
| Extrapulmonary TB# | 24 (38) | 33 (55) |
| Microbiologically confirmed TB | 53 (70) | 59 (79) |
| Previous TB | 6 (8) | 8 (11) |
| Time on TB treatment at week 0 days | 16 (15–22) | 16 (14–21) |
| Smoking status at week 0¶ pack-years | ||
| Never smoked | 36 (55) | 41 (67) |
| Ever smoked | 30 (45)/2.2 (0.8–5.0) | 20 (33)/3.75 (1.0–10.0) |
| Previous lung disease | 1 (1.3) | 0 (0) |
| Spirometry | ||
| FEV1 % pred | 75 (61–88) | 73 (59–86) |
| FVC % pred | 74 (66–89) | 73 (65–81) |
| FVC/FEV1 % | 83 (79–85) | 82 (77–86) |
| TB-IRIS | 30 (39) | 41 (54) |
| Treatment with open-label prednisone for suspected TB-IRIS | 16 (21) | 30 (39) |
Data are presented as n (%) or median (interquartile range). TB: tuberculosis (pulmonary TB: participants with one or more pulmonary signs or symptoms (such as cough, shortness of breath, abnormal chest radiograph) of TB at presentation; extrapulmonary TB: participants with signs of extrapulmonary tuberculosis (such as pleural effusion or enlarged lymph nodes); microbiologically confirmed TB: participants with Mycobacterium tuberculosis detected on culture, with the use of the Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA, USA), or as positive acid-fast bacilli on smear microscopy); FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity. #: n=123; ¶: n=127.