ODYSSEY A | ODYSSEY B | Total | |||||
---|---|---|---|---|---|---|---|
(First-line) | (Second-line) | ||||||
Participants randomised ≥14 kg | 311 | 396 | 707 | ||||
Country/region | |||||||
Europe | 18 | (6%) | 7 | (2%) | 25 | (4%) | |
South Africa | 76 | (24%) | 67 | (17%) | 143 | (20%) | |
Thailand | 50 | (16%) | 11 | (3%) | 61 | (9%) | |
Uganda | 99 | (32%) | 232 | (59%) | 331 | (47%) | |
Zimbabwe | 68 | (22%) | 79 | (20%) | 147 | (21%) | |
Sex | |||||||
Male | 147 | (47%) | 215 | (54%) | 362 | (51%) | |
Female | 164 | (53%) | 181 | (46%) | 345 | (49%) | |
Age, years | |||||||
2 to < 6 | 12 | (4%) | 14 | (4%) | 26 | (4%) | |
6 to < 12 | 155 | (50%) | 161 | (41%) | 316 | (45%) | |
12 to < 18 | 144 | (46%) | 221 | (56%) | 365 | (52%) | |
Weight, kg | |||||||
14 to < 20 | 38 | (12%) | 44 | (11%) | 82 | (12%) | |
20 to < 25 | 62 | (20%) | 73 | (18%) | 135 | (19%) | |
25 to < 30 | 58 | (19%) | 59 | (15%) | 117 | (17%) | |
30 to < 35 | 33 | (11%) | 56 | (14%) | 89 | (13%) | |
35 to < 40 kg | 22 | (7%) | 39 | (10%) | 61 | (9%) | |
≥40 kg | 98 | (31%) | 125 | (32%) | 223 | (31%) | |
BMI-for-Age Z-Scorea | |||||||
<−3 | 12 | (4%) | 21 | (5%) | 33 | (5%) | |
−3 to < −2 | 24 | (8%) | 24 | (6%) | 48 | (7%) | |
−2 to < 0 | 178 | (57%) | 257 | (65%) | 435 | (62%) | |
≥0 | 97 | (31%) | 94 | (24%) | 191 | (27%) | |
Mode of infection | |||||||
Mother-to-child | 240 | (77%) | 365 | (92%) | 605 | (86%) | |
Blood product | 1 | (<1%) | 2 | (1%) | 3 | (<1%) | |
Sexual contact | 36 | (12%) | 3 | (1%) | 39 | (6%) | |
Unknown | 32 | (10%) | 26 | (7%) | 58 | (8%) | |
Otherd | 2 | (1%) | 0 | (0%) | 2 | (<1%) | |
CD4, cells/mm3b | |||||||
< 100 | 56 | (18%) | 54 | (14%) | 110 | (16%) | |
100 to < 200 | 20 | (6%) | 29 | (7%) | 49 | (7%) | |
200 to < 500 | 103 | (33%) | 128 | (32%) | 231 | (33%) | |
500 to < 1000 | 99 | (32%) | 130 | (33%) | 229 | (32%) | |
≥1000 | 33 | (11%) | 55 | (14%) | 88 | (13%) | |
CD4, % | |||||||
< 15 | 110 | (35%) | 119 | (30%) | 229 | (32%) | |
15 to < 25 | 100 | (32%) | 104 | (26%) | 204 | (29%) | |
≥25 | 101 | (32%) | 173 | (44%) | 274 | (39%) | |
Median CD4 (IQR), cells/mm3b | 436 | (210–660) | 482 | (243–752) | 459 | (228–704) | |
Viral load, copies/mLb | |||||||
< 1000 | 25 | (8%) | 6 | (2%) | 31 | (4%) | |
1000 to < 10,000 | 62 | (20%) | 122 | (31%) | 184 | (26%) | |
10,000 to < 50,000 | 76 | (24%) | 151 | (38%) | 227 | (32%) | |
50,000 to < 100,000 | 44 | (14%) | 44 | (11%) | 88 | (13%) | |
≥100,000 | 101 | (33%) | 73 | (18%) | 174 | (25%) | |
Median Log10 Viral load (IQR), copies/mLb | 4.6 | (3.9–5.1) | 4.3 | (3.8–4.8) | 4.4 | (3.9–5.0) | |
Clinical (WHO) Staging | |||||||
I | 127 | (41%) | 143 | (36%) | 270 | (38%) | |
II | 113 | (36%) | 135 | (34%) | 248 | (35%) | |
III | 47 | (15%) | 81 | (21%) | 128 | (18%) | |
IV | 23 | (8%) | 37 | (9%) | 60 | (8%) | |
Previous ART Class Exposurec | |||||||
NRTI/NNRTI | 382 | (96%) | |||||
NRTI/NNRTI/PIs | 4 | (1%) | |||||
NRTI/PIs | 10 | (3%) | |||||
Median cumulative ART exposure (IQR), yearsc | 5.5 | (3.5–8.1) |