Table 2.
Patient characteristics
| ART-Def, Median (IQR) [N] or N (%) | ART-40 W, Median (IQR) [N] or N (%) | ART-96 W, Median (IQR) [N] or N (%) | Total, Median (IQR) [N] or N (%) | |
|---|---|---|---|---|
| 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] |
PMTCT prevention of mother to child transmission