Table 2 Patient characteristics

Number of patients

79

56

94

229

Age at randomisation (weeks)

7.3 (6.4, 9.1) [79]

7.9 (7.3, 9.2) [56]

7.6 (6.7, 8.6) [94]

7.6 (6.7, 9.0) [229]

Age at ART start (weeks)

26.1 (20.0, 42.9) [79]

7.9 (7.3, 9.2) [56]

7.6 (6.7, 8.6) [94]

8.7 (7.4, 20.1) [229]

Birthweight (kg)

2.9 (2.6, 3.3) [79]

2.9 (2.6, 3.2) [56]

3.0 (2.7, 3.3) [94]

2.9 (2.6, 3.3) [229]

Gender

 Female

49 (62.0%)

28 (50.0%)

52 (55.3%)

129 (56.3%)

 Male

30 (38.0%)

28 (50.0%)

42 (44.7%)

100 (43.7%)

Ethnic origin

 Black

79 (100.0%)

52 (92.9%)

89 (94.7%)

220 (96.1%)

 Non-black

0 (0.0%)

4 (7.1%)

5 (5.3%)

9 (3.9%)

Infant PMTCT

 No

9 (11.4%)

5 (8.9%)

14 (14.9%)

28 (12.2%)

 Yes

67 (84.8%)

49 (87.5%)

77 (81.9%)

193 (84.3%)

 Unknown

3 (3.8%)

2 (3.6%)

3 (3.2%)

8 (3.5%)

Mother PMTCT

 No

10 (12.7%)

6 (10.7%)

10 (10.6%)

26 (11.4%)

 Yes

69 (87.3%)

50 (89.3%)

84 (89.4%)

203 (88.6%)

Clinical site

 KIDCRU

24 (30.4%)

26 (46.4%)

29 (30.9%)

79 (34.5%)

 PHRU

55 (69.6%)

30 (53.6%)

65 (69.1%)

150 (65.5%)

CDC stage

 A

6 (7.6%)

19 (33.9%)

13 (13.8%)

38 (16.6%)

 B

4 (5.1%)

1 (1.8%)

6 (6.4%)

11 (4.8%)

 N

69 (87.3%)

36 (64.3%)

75 (79.8%)

180 (78.6%)

Cytomegalovirus serology

 Negative

49 (62.0%)

37 (66.1%)

64 (68.1%)

150 (65.5%)

 Positive

10 (12.7%)

11 (19.6%)

18 (19.1%)

39 (17.0%)

 No sample/missing

20 (25.3%)

8 (14.3%)

12 (12.8%)

40 (17.5%)

Viral load (copies/ml)

 At randomisation

7,50,001 (5,01,000; 7,50,001) [79]

5,57,500 (1,94,000; 7,50,001) [56]

7,50,001 (6,45,000; 7,50,001) [94]

7,50,001 (4,39,000; 7,50,001) [229]

 At ART start

7,50,001 (1,42,400; 7,50,001) [78]

5,57,500 (1,94,000; 7,50,001) [56]

7,50,001 (6,45,000; 7,50,001) [94]

7,50,001 (3,38,000; 7,50,001) [228]

Log₁₀ viral load (copies/ml)

 At randomisation

5.9 (5.7, 5.9) [79]

5.7 (5.3, 5.9) [56]

5.9 (5.8, 5.9) [94]

5.9 (5.6, 5.9) [229]

 At ART start

5.9 (5.2, 5.9) [78]

5.7 (5.3, 5.9) [56]

5.9 (5.8, 5.9) [94]

5.9 (5.5, 5.9) [228]

Immunology

 CD4%

  At screening

37 (31, 42) [78]

34 (29, 40) [56]

36 (31, 42) [94]

36 (31, 42) [228]

  At randomisation

35 (29, 39) [75]

35 (30, 41) [54]

34 (29, 38) [89]

35 (29, 39) [218]

  At ART start

22 (19, 30) [78]

35 (30, 41) [54]

34 (29, 38) [89]

31 (25, 37) [221]

 CD4 count

  At screening

2543 (1771, 3062) [78]

1955 (1405, 2431) [56]

2242 (1661, 2995) [94]

2225 (1611, 2986) [228]

  At randomisation

1968 (1572, 2542) [75]

1918 (1279, 2555) [54]

2002 (1480, 2762) [89]

1956 (1446, 2688) [218]

  At ART start

1079 (712, 1495) [78]

1918 (1279, 2555) [54]

2002 (1480, 2762) [89]

1574 (1103, 2425) [221]

 CD8%

  At screening

23 (21, 34) [77]

28 (20, 34) [54]

26 (21, 33) [93]

26 (21, 34) [224]

  At randomisation

25 (21, 33) [78]

28 (22, 34) [54]

27 (22, 34) [93]

27 (21, 34) [225]

  At ART start

34 (29, 43) [79]

28 (22, 34) [54]

27 (22, 34) [93]

30 (23, 37) [226]

 CD8 count

  At screening

1589 (1153, 2480) [77]

1494 (1050, 2026) [54]

1648 (1142, 2243) [93]

1597 (1135, 2238) [224]

  At randomisation

1416 (1115, 2227) [78]

1331 (998, 2025) [54]

1686 (1139, 2386) [93]

1471 (1094, 2258) [225]

  At ART start

1465 (874, 2454) [79]

1331 (998, 2025) [54]

1686 (1139, 2386) [93]

1530 (1036, 2294) [226]