TABLE 1.

CLINICAL AND DEMOGRAPHIC CHARACTERISTICS OF PARTICIPANTS INCLUDED IN IMMUNOLOGICAL ANALYSES

Variable	Placebo Treated (n = 27)	Prednisone Treated (n = 31)	P Value
Sex
Male	13 (48%)	12 (39%)
Female	14 (52%)	19 (61%)	0.8
Age	31 (27–36)	31 (26–35)	0.6
Previous TB	6 (22%)	10 (32%)	0.6
Basis of TB diagnosis
Cultured Mycobacterium tuberculosis	20 (74%)	17 (55%)
Acid-fast bacilli smear positive	5 (19%)	4 (13%)
Clinicoradiological diagnosis	2 (7%)	10 (32%)	0.07
Extrapulmonary TB at TB diagnosis	15 (56%)	16 (52%)	0.8
CD4 count before ART, cells/μl	58 (20–95)	55 (31–94)	0.6
CD4 count at enrollment, cells/μl*	107 (49–202)	117 (73–278)	0.2
C-reactive protein at enrollment, mg/L	100 (80–143)	94 (42–150)	0.6
Duration TB treatment to ART, d	43 (26–79)	69 (35–96)	0.09
Duration ART to TB-IRIS symptom onset, d	10 (7–17)	14 (7–22)	0.1
TB-IRIS clinical manifestations†
New or enlarging lymph node(s)	11 (41%)	9 (29%)	0.4
New or expanding pulmonary infiltrate(s)	6 (22%)	9 (29%)	0.8
New or enlarging serous effusion(s)	3 (11%)	2 (6%)	0.7
Recurrent symptoms and infiltrate(s) on CXR but without baseline CXR available for comparison	10 (37%)	14 (45%)	0.6

Definition of abbreviations: ART = antiretroviral therapy; CXR = chest radiograph; TB = tuberculosis; TB-IRIS = tuberculosis-associated immune reconstitution inflammatory syndrome.

Values shown represent numbers (percentage) or median (interquartile range). P values compare placebo- and prednisone-treated participants.

^*CD4 count at enrollment available for 24 placebo-treated and 27 prednisone-treated participants.

^†Participants may have had more than one TB-IRIS manifestation, and thus manifestations sum to more than 100%