Table 1. Baseline Characteristics-Health Status.
| Variable | ART-Def | ART-40W | ART-96W |
|---|---|---|---|
|
| |||
| Number of participants enrolled | 125 | 126 | 126 |
| Age (weeks) at randomization | |||
| Median (IQR) | 7.1 (6.4 to 8.9) | 7.4 (6.6 to 8.7) | 7.5 (6.6 to 9.0) |
| Mother/Child receiving ART for PMTCT | |||
| No therapy (%) | 15 (12)/19 (15) | 13 (10)/18 (14) | 12 (10)/18 (14) |
| * NVP (%) | 72 (58)/67 (54) | 85 (68)/66 (52) | 80 (64)/61 (48) |
| AZT (%) | 5 (4)/1 (< 1) | 6 (5)/2 (2) | 3 (2)/3 (2) |
| AZT + NVP (%) | 26 (21)/34 (27) | 20 (16)/32 (25) | 30 (24)/37 (29) |
| HAART (%) | 7 (6)/0 (0) | 2 (2)/0 (0) | 1 (< 1)/0 (0) |
| Baseline weight (kg) | |||
| Median (IQR) | 4.5 (4.0 to 5.0) | 4.3 (4.0 to 4.8) | 4.4 (3.8 to 5.0) |
| Weight Z-score | |||
| Median (IQR) | -0.6 (-1.3 to 0.2) | -0.8 (-1.4 to-0.2) | -0.7 (-1.6 to 0.0) |
| Birth weight (kg) | |||
| < 2.5 (%) | 23 (18.4) | 18 (14.3) | 21 (16.7) |
| 2.5-3.0 (%) | 39 (31.2) | 46 (36.5) | 42 (33.3) |
| 3.0-3.5 (%) | 50 (40.0) | 47 (37.3) | 52 (41.3) |
| ≥3.5 (%) | 13 (10.4) | 15 (11.9) | 11 (8.7) |
| Median (IQR) | 3 (2.7 to 3.2) | 3 (2.7 to 3.2) | 3 (2.7 to 3.3) |
| CDC Classification | |||
| Class N (%) | 106 (84.8) | 97 (77.0) | 105 (83.3) |
| Class A (%) | 13 (10.4) | 24 (19.0) | 13 (10.3) |
| Class B (%) | 6 (4.8) | 5 (4.0) | 8 (6.3) |
| CD4% | |||
| Median (IQR) | 35.7 (29.1 to 43.6) | 35.3 (29.5 to 41.8) | 34.1 (29.0 to 39.9) |
| CD4 Count (cells/mm3) | |||
| Median (IQR) | 2039 (1585 to 2960) | 1985.5 (1476 to 2793) | 2069.5 (1537 to 2743) |
| Screening viral loads (1,000/ml) | |||
| 10-100 (%) | 9 (7) | 6 (5) | 6 (5) |
| 100-500 (%) | 27 (22) | 42 (33) | 26 (21) |
| 500-750 (%) | 15 (12) | 15 (12) | 19 (15) |
| >750 (%) | 74 (59) | 63 (50) | 75 (60) |
| Mean log10 viral load (std) | 5.7 (0.4) | 5.6 (0.3) | 5.7 (0.4) |
*
Single dose nevirapine