Table 1.

Baseline characteristics of participants in the SAPiT trial

Variable	Early integrated- treatment am (N=214)	Late integrated- treatment arm (N=215)	Sequential- treatment arm (N=213)	P-value	Patients who developed IRIS (N=80)	Patients who did not develop IRIS (N=562)	P-value
Age in years (mean (SD))	34.3 (8.0)	34.5 (8.7)	33.9 (8.2)	0.64	34.3 (6.4)	34.2 (8.5)	0.97
Number of males (%)	97 (45.3)	112 (52.1)	110 (51.6)	0.30	39 (48.8)	280 (49.8)	0.91
BMI (kg/m²) <18.5 (%) ^*	25 (11.7)	28 (13.0)	29 (13.6)	0.79	10 (12.5)	72 (12.9)	1.00
History of tuberculosis (%)	80 (37.4)	68 (31.6)	66 (31.0)	0.31	31 (38.8)	183 (32.6)	0.31
Extra pulmonary tuberculosis (%) ^†	10 (4.7)	9 (4.2)	9 (4.3)	1.00	5 (6.3)	23 (4.1)	0.38
WHO stage 4(%)	14 (6.5)	11 (5.1)	13 (6.1)	0.80	6 (7.5)	32 (5.7)	0.46
CD4+ count cells/mm³, median (IQR)	154.5 (75-261)	149 (77-244)	140 (69-247)	0.60	91 (36-176.5)	155 (78-261)	<0.0001
Number of patients with CD4+ count < 50 cells/mm (%)	37 (17.3)	35 (16.3)	41 (19.2)	0.71	26 (32.5)	87 (15.5)	<0.001
CD8 count cells/mm³, median (IQR)	697(417-1030)	659.5 (455-1084)	663 (476-957)	0.93	586 (371.5-987)	676 (475-1007)	0.09
Log₁₀ HIV RNA, copies/ml, mean (SD) ^‡	5.0 ( 0.9)	5.0 ( 0.9)	5.1 (0.7)	0.38	5.5 (0.7)	5.0 (0.9)	<0.0001

IQR-Interquartile range SD-standard 2 deviation BMI-Body Mass Index IRIS–Immune Reconstitution Inflammatory Syndrome

5 patients in the sequential -treatment arm had missing BMI and missing data is not included in percentage calculation

^†

1 patient in the late integrated- treatment arm and 3 patients in the sequential -treatment arm had missing extra pulmonary tuberculosis and missing data is not included in percentage calculation

^‡

Baseline viral load was not available for 16 patients in each of the early integrated- and late integrated -treatment arms and 12 in the sequential arm