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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)

From: Efavirenz-based simplification after successful early lopinavir-boosted-ritonavir-based therapy in HIV-infected children in Burkina Faso and Côte d’Ivoire: the MONOD ANRS 12206 non-inferiority randomised trial

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
  1. AZT Zidovudine, ABC Abacavir, 3TC Lamivudine, LPV/r Lopinavir-boosted ritonavir, EFV Efavirenz, IQR Interquartile range, VL Viral load, SD Standard deviation
  2. aSevere immunodeficiency for age: CD4 < 25% if aged <2 years, CD4 < 20% if aged ≥2 years; mild immunodeficiency for age: CD4 between 25 and 35% if aged <2 years, CD4 between 20 and 35% if aged ≥2 years; No immunodeficiency for age if CD4 > 35%