| Total study duration n (%) | Subjects with Time Period 1 non IRIS-attributable hospitalization n (%) | Subjects with Time Period 1 IRIS-attributable hospitalization n (%) | p value | Subjects with Time Period 2 non IRIS-attributable hospitalization n (%) | Subjects with Time Period 2 IRIS-attributable hospitalization n (%) | p value |
---|---|---|---|---|---|---|---|
Total subjects | 278 | 151 | 9 | Â | 112 | 6 | Â |
Mean age | 47.5 | 47.7 | 42.8 | 0.17 | 47.7 | 47.3 | 0.94 |
Sexa | Â | Â | Â | 0.73 | Â | Â | 0.66 |
 Male | 192 (69) | 105 (70) | 7 (78) |  | 75 (67) | 5 (83) |  |
 Female | 86 (31) | 46 (30) | 2 (22) |  | 37 (33) | 1 (17) |  |
Race/ethnicity | Â | Â | Â | 0.08 | Â | Â | 0.008 |
 White | 121 (44) | 61 (40) | 2 (22) |  | 58 (52) | 0 (0) |  |
 Black | 147 (53) | 84 (56) | 5 (56) |  | 53 (47) | 5 (83) |  |
 Hispanic | 5 (2) | 4 (3) | 1 (11) |  | 0 (0) | 0 (0) |  |
 Other/unknown | 5 (2) | 2 (1) | 1(11) |  | 1 (1) | 1 (17) |  |
CD4 countb | Â | Â | Â | 0.004 | Â | Â | 0.18 |
 <200 | 112 (40) | 59 (39) | 8 (89) |  | 40 (36) | 5 (83) |  |
 200–500 | 86 (31) | 47 (31) | 1 (11) |  | 37 (33) | 1 (17) |  |
 >500 | 69 (25) | 39 (26) | 0 (0) |  | 30 (27) | 0 (0) |  |
HIV viral loadc | Â | Â | Â | 0.54 | Â | Â | 0.04 |
 <200 | 154 (55) | 89 (59) | 4 (44) |  | 60 (54) | 1 (17) |  |
 200–1000 | 10 (4) | 7 (5) | 0 (0) |  | 2 (2) | 1 (17) |  |
 >1000 | 103 (37) | 49 (32) | 5 (56) |  | 45 (40) | 4 (66) |  |
Hepatitis B co-infectiond | Â | Â | Â | 0.47 | Â | Â | 0.21 |
 Chronic infection | 59 (21) | 15 (10) | 2 (22) |  | 15 (13) | 1 (17) |  |
 Exposure and clearance | 33 (12) | 35 (23) | 1 (11) |  | 20 (18) | 3 (50) |  |
 No exposure or infection | 162 (58) | 88 (58) | 5 (56) |  | 67 (60) | 2 (33) |  |
Hepatitis C co-infectione | Â | Â | Â | 0.58 | Â | Â | 1.00 |
 Chronic infection | 16 (6) | 31 (21) | 1 (11) |  | 18 (16) | 1 (17) |  |
 Exposure and clearance | 51 (18) | 10 (7) | 1 (11) |  | 5 (4) | 0 (0) |  |
 No exposure or infection | 189 (68) | 99 (66) | 6 (67) |  | 79 (71) | 5 (83) |  |