Table 2 Twelve-month post-randomisation primary and secondary outcomes in the 106 HIV-1-infected children randomised in the ANRS 12206 MONOD study according to arm (Abidjan and Ouagadougou, February 2013–April 2015)
12-month outcomes | Total N = 106 | Arm 1: AZT + 3TC + LPV/r (twice daily) N = 54 | Arm 2: ABC + 3TC + EFV (once daily) N = 52 | p value |
|---|---|---|---|---|
Follow-up (months), median (IQR) | 12.7 (12.1–13.0) | 12.7 (12.1–13.0) | 12.6 (12.1–13.0) | 0.44 |
Death | 0 (0.0) | 0 (0.0) | 0 (0.0) | - |
Loss to follow-up | 0 (0.0) | 0 (0.0) | 0 (0.0) | - |
Withdrawal | 0 (0.0) | 0 (0.0) | 0 (0.0) | - |
Virological success (VL < 500 copies/mL) | 89 (84.0) | 46 (85.2) | 43 (82.7) | 0.72 |
Virological failure (500 ≥ VL < 1000 copies/mL) | 3 (2.8) | 1 (1.8) | 2 (3.8) | - |
Virological failure (VL ≥ 1000 copies/mL) | 14 (13.2) | 7 (13.0) | 7 (13.5) | 0.59 |
CD4 %, median (IQR) | 37.3 (31.6–41.9) | 37.3 (31.3–41.6) | 37.1 (31.6–42.0) | 0.85 |
Immunodeficiency for agea | 0.59 | |||
None | 57 (53.8) | 32 (59.3) | 25 (48.1) | |
Mild | 38 (35.9) | 17 (31.5) | 21 (40.4) | |
Severe | 3 (2.8) | 2 (3.7) | 1 (1.9) | |
Missing | 8 (7.6) | 3 (5.6) | 5 (9.6) | |
Z-score, mean (SD) | ||||
Weight-for-age | −1.2 (0.9) | −1.3 (0.8) | −1.2 (1.0) | 0.63 |
Height-for-age | −1.4 (1.1) | −1.5 (1.1) | −1.4 (1.2) | 0.84 |
Weight-for-height | −0.6 (0.8) | −0.6 (0.9) | −0.5 (0.8) | 0.62 |