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)
| 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) | – |
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