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Table 6 Baseline characteristics of odyssey participants ≥14 kg at randomisation

From: ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing

   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)   
  1. Percentages are of non-missing values. Abbreviations: BMI Body Mass Index, ART Antiretroviral Therapy, NRTI Nucleos(t) ide reverse transcriptase inhibitors, PI Protease Inhibitors, NNRTI Non-nucleoside reverse-transcriptase inhibitors, IQR Interquartile Range
  2. aAssessed using World Health Organization (WHO) 2007 STATA macro package [35].
  3. bMean of results at screening and randomisation if both are available
  4. cExcluding any PMTCT exposure
  5. d 1 injecting drug use; 1 possible transmission father-to-child
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