Table 1. Baseline characteristics by treatment strategy.
Standard vs. Intensive ART | ART Interruption vs. Continuation | |||||
Standard ART | Intensive ART | Total | ART Interruption | ART Continuation | Total | |
Number of patients Randomized | 192 | 176 | 368 | 164 | 175 | 339 |
Mean Age in years (SD) | 48.4 (8.65) | 47.6 (8.31) | 48.0 (8.49) | 48.7 (8.32) | 48.5 (8.47) | 48.6 (8.39) |
Age Categories (%): | ||||||
31–40 | 36 (19) | 32 (18) | 68 (18) | 27 (16) | 27 (15) | 54 (16) |
41–50 | 77 (40) | 79 (45) | 156 (42) | 66 (40) | 76 (43) | 142 (42) |
51–60 | 65 (34) | 56 (32) | 121 (33) | 59 (36) | 61 (35) | 120 (35) |
>60 | 14 (7) | 9 (5) | 23 (6) | 12 (7) | 11 (6) | 23 (7) |
Gender (%): | ||||||
Male | 189 (98) | 172 (98) | 361 (98) | 160 (98) | 172 (98) | 332 (98) |
Female | 3 (2) | 4 (2) | 7 (2) | 4 (2) | 3 (2) | 7 (2) |
Race (%): | ||||||
White | 90 (47) | 90 (51) | 180 (49) | 73 (45) | 87 (50) | 160 (47) |
Black | 80 (42) | 64 (36) | 144 (39) | 67 (41) | 71 (41) | 138 (41) |
Asian | 2 (1) | 0 (0) | 2 (1) | 0 (0) | 1 (1) | 1 (0) |
Hispanic | 15 (8) | 21 (12) | 36 (10) | 21 (13) | 15 (9) | 36 (11) |
Aboriginal | 2 (1) | 0 (0) | 2 (1) | 1 (1) | 1 (1) | 2 (1) |
Other | 3 (2) | 1 (1) | 4 (1) | 2 (1) | 0 (0) | 2 (1) |
Mode of Infection (%): | ||||||
Blood | 20 (10) | 15 (9) | 35 (10) | 15 (9) | 19 (11) | 34 (10) |
Heterosexual | 47 (24) | 39 (22) | 86 (23) | 41 (25) | 39 (22) | 80 (24) |
IDU | 27 (14) | 25 (14) | 52 (14) | 24 (15) | 27 (15) | 51 (15) |
MSM | 87 (45) | 88 (50) | 175 (48) | 76 (46) | 79 (45) | 155 (46) |
Other | 9 (5) | 9 (5) | 18 (5) | 6 (4) | 11 (6) | 17 (5) |
Unknown | 2 (1) | 0 (0) | 2 (1) | 2 (1) | 0 (0) | 2 (1) |
AIDS or prior AIDS at entry (%) | 107 (56) | 109 (62) | 216 (59) | 95 (58) | 105 (60) | 200 (59) |
Hepatitis B (HBsAg+) (%) | 26 (14) | 13 (7) | 39 (11) | 23 (14) | 14 (8) | 37 (11) |
Hepatitis C (anti-HCV Ab+) (%) | 46 (24) | 34 (19) | 80 (22) | 39 (24) | 38 (22) | 77 (23) |
HIV RNA copies/ml (%) | ||||||
<5k | 14 (7) | 17 (10) | 31 (8) | 19 (12) | 12 (7) | 31 (9) |
5–50k | 72 (38) | 58 (33) | 130 (35) | 56 (34) | 68 (39) | 124 (37) |
50–100k | 35 (18) | 28 (16) | 63 (17) | 32 (20) | 27 (15) | 59 (17) |
>100k | 70 (37) | 73 (41) | 143 (39) | 56 (34) | 68 (39) | 124 (37) |
mean log10 (SD) | 4.74 (0.62) | 4.74 (0.75) | 4.74 (0.68) | 4.67 (0.71) | 4.75 (0.66) | 4.71 (0.68) |
CD4 cells/µl | ||||||
Mean (SD) | 129 (107) | 125 (106) | 127 (107) | 129 (106) | 131(109) | 130(108) |
median | 109 | 102 | 106 | 109 | 111 | 110 |
Virtual Phenotypic Susceptibility Score (PSS) (mean) | 1.3 | 1.7 | 1.5 | 1.4 | 1.5 | 1.5 |