Skip to main content

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