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Table 1 Baseline characteristics according to randomisation arm of the 106 HIV-1-infected children randomised in the ANRS 12206 MONOD trial (Abidjan and Ouagadougou, May 2011–April 2014)

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

Characteristics Total N = 106 AZT or ABC + 3TC + LPV/r (twice daily) N = 54 ABC + 3TC + EFV (once daily) N = 52 p value
Pre-trial characteristics
 Abidjan site, n (%) 71 (67.0) 36 (66.7) 35 (67.3) 0.94
 Age (months) at HIV-1 diagnosis, median (IQR) 8. 5 (3.3–15.6) 8.4 (3.8–16.5) 9.8 (2.8–15.4) 0.84
 Age (months) at ART initiation, median (IQR) 13.7 (7.9–18.4) 12.8 (8.1–18.4) 14.2 (7.6–18.4) 0.96
 Female, n (%) 59 (55.7) 35 (64.8) 24 (46.2) 0.05
 Father or other as main caregiver, n (%) 18 (17.0) 10 (18.5) 8 (15.4) 0.67
 Tap water at home, n (%) 78 (73.6) 39 (72.2) 39 (75.0) 0.74
 Electricity at home, n (%) 84 (79.2) 43 (79.6) 41 (78.9) 0.92
 Ever breastfed from birth, n (%) 92 (86.8) 45 (83.3) 47 (90.4) 0.28
 Breastfeeding duration (months) for those breastfed, median (IQR) 13.8 (7.6–21.4) 16.0 (7.5–21.5) 12.0 (7.7–19.6) 0.49
History of antiretroviral drug exposure
 Prenatal maternal ART, n (%) 9 (8.5) 5 (9.3) 4 (7.7) 1.00
  AZT/TDF + 3TC/FTC + NVP 8 (88.9) 4 (80.0) 4 (100.0)  
  AZT + 3TC + EFV 1 (11.1) 1 (20.0) 0 (0.0)  
 PMTCT and postnatal maternal ART 10 (9.4) 7 (13.0) 3 (5.8) 0.32
  PMTCT     1.00
   sdNVP-based PMTCT 2 (20.0) 2 (28.6) 0 (0.0)  
   Other than sdNVP-based PMTCT 8 (80.0) 5 (71.4) 3 (100.0)  
  Postnatal maternal HAART     1.00
   AZT/TDF + 3TC/FTC + NVP 8 (80.0) 5 (71.4) 3 (100.0)  
   AZT + 3TC + LPV/r 2 (20.0) 2 (28.6) 0 (0.0)  
 PMTCT only 32 (30.2) 15 (27.8) 17 (32.7) 0.58
  Only sdNVP-based PMTCT 5 (15.6) 3 (20.0) 2 (11.8)  
  Other than sdNVP-based PMTCT 27 (84.4) 12 (80.0) 15 (88.2)  
 Postnatal maternal ART only 13 (12.3) 7 (13.0) 6 (11.5) 0.82
  D4T/AZT + 3TC + NVP 8 (61.5) 4 (57.1) 4 (66.7)  
  AZT/D4T/TDF + 3TC/FTC + EFV 3 (23.1) 2 (28.6) 1 (16.7)  
  D4T + 3TC + LPV/r 1 (7.7) 0 (0.0) 1 (16.7)  
  Missing 1 (7.7) 1 (14.3) 0 (0.0)  
 No previous exposure to any PMTCT or maternal ART 42 (39.6) 20 (37.0) 22 (42.3) 0.58
Z-scores at child’s ART initiation, mean (SD)
  Weight-for-age −2.3 (1.5) −2.3 (1.4) −2.3 (1.6) 0.81
  Height-for-age −2.2 (1.7) −2.1 (1.7) −2.3 (1.7) 0.53
  Weight-for-height −1.5 (1.4) −1.5 (1.3) −1.4 (1.5) 0.84
 WHO stage     0.86
  Stage 1 or 2, n (%) 48 (45.3) 24 (44.4) 24 (46.2)  
  Stage 3 or 4, n (%) 58 (54.7) 30 (55.6) 28 (53.9)  
 Haemoglobin (g/dL), median (IQR) 9.2 (8.4–9.9) 9.1 (8.5–10.0) 9.4 (8.4–9.9) 0.75
 CD4 %, median (IQR) 20.8 (14.2–28.1) 18.9 (13.9–27.4) 21.2 (15.0–28.8) 0.65
 Viral load (log10 copies/mL), median (SD) 6.1 (1.0) 6.2 (1.0) 6.0 (1.0) 0.51
 Viral load ≥6 log10 copies/mL, n (%) 58 (54.7) 30 (55.6) 28 (53.8) 0.86
 First-line NRTI backbone     0.31
  ZDV-3TC, n (%) 95 (89.6) 50 (92.6) 45 (86.5)  
  ABC-3TC, n (%) 11 (10.4) 4 (7.4) 7 (13.5)  
 Ever start cotrimoxazole, n (%) 104 (98.1) 53 (98.1) 51 (98.1) 1.00
At randomisation
 Age (months), median (IQR) 26.8 (21.5–31.5) 26.0 (21.8–31.3) 27.2 (20.8–31.5) 0.84
 Duration on HAART (months), median (IQR) 12.7 (12.1–13.0) 12.7 (12.1–13.0) 12.6 (12.1–13.0) 0.86
 Weight (kg), median (IQR) 10.2 (9.2–11.4) 10.2 (9.3–11.2) 10.2 (9.1–11.6) 0.92
 WHO stage 3 or 4, n (%) 49 (46.2) 25 (46.3) 24 (46.1) 0.99
 CD4 %, median (IQR) 35.9 (28.5–40.9) 36.4 (28.5–40.7) 34.9 (28.5–41.1) 0.63
 On cotrimoxazole, n (%) 106 (100.0) 54 (100.0) 52 (100.0)
  1. AZT Zidovudine, ABC Abacavir, 3TC Lamivudine, LPV/r Lopinavir-boosted ritonavir, EFV Efavirenz, IQR Interquartile range, ART Antiretroviral therapy, TDF Tenofovir, FTC Emtricitabine, NVP Nevirapine, PMTCT Prevention of mother-to-child-transmission, sdNVP Single-dose nevirapine, HAART Highly active antiretroviral therapy, D4T Stavudine, SD Standard deviation, WHO World Health Organization, NRTI Nucleoside reverse transcriptase inhibitor