Table 1.
Characteristics of women at enrollment, delivery and neonates
| Maternal Characteristics at enrollment
|
NVP-NVP (N=138)
|
Infant-only NVP (N=129)
|
LPV/r (N=145)
|
All (N=412)
|
|---|---|---|---|---|
| Median Age (Interquartile range)(IQR) (years) | 27 (23.0–32.0) | 28 (23.0–33.0) | 27 (23.0–32.0) | 27 (23.0–32.0) |
| Median gestational age at enrollment (IQR) (weeks) | 28.7 (28.3–31.0) | 28.6 (28.1–30.4) | 28.4 (28.1–30.4) | 28.6 (28.1–30.4) |
| Median CD4 count (IQR) (cells/mm3) | 456 (366–577) | 452 (360–568) | 451 (363–583) | 453 (363–577) |
| Median Viral load (IQR) (log10 copies/mL) | 4.0 (3.5–4.6) | 3.9 (3.4–4.3) | 4.1 (3.4–4.5) | 4.0 (3.4–4.4) |
| WHO classification stage 2 (%) | 2.9 | 1.6 | 2.1 | 2.2 |
| Median gestational age at start of ZDV (IQR) (weeks) | 28.4 (28.0–29.0) | 28.3 (28.0–28.9) | 28.3 (28.0–29.0) | 28.3 (28.0–28.9) |
| Median Hemoglobin level (IQR) (g/dL) | 11.2 (10.4–11.8) | 11.0 (10.4–11.6) | 11.1 (10.5–11.7) | 11.1 (10.4–11.7) |
| Hepatitis B surface antigenemia (%) | 4.4 | 5.4 | 4.8 | 4.9 |
| Hepatitis C antibodies (%) | 4.4 | 2.3 | 2.8 | 3.2 |
| Exposure to PMTCT during a previous pregnancy (%) | 4.9 | 5.0 | 4.6 | 4.8 |
| Delivery Characteristics (excluding women who delivered after study unblinding)
|
NVP-NVP (N=135)
|
Infant-only NVP (N=128)
|
LPV/r (N=142)
|
All (N=405)
|
|---|---|---|---|---|
| Median length of gestation at delivery (IQR) (weeks) | 38.7 (37.8–39.6) | 38.9 (37.9–40.0) | 38.5 (37.6–39.5) | 38.7 (37.8–39.7) |
| Median duration of ZDV therapy (IQR) (weeks) | 10.1 (8.4–11.1) | 10.3 (9.1–11.4) | 10.0 (8.6–11.1) | 10.1 (8.6–11.1) |
| Median time from onset of labor to maternal study drug administration (hours) | 3.0 (1.7–5.9) | 2.9 (1.5–5.6) | - | 3.0 (1.6–5.6) |
| Median time from maternal study drug administration to delivery (hours) | 4.4 (1.9–8.4) | 4.0 (1.6–7.8) | - | 4.2 (1.7–8.1) |
| Median duration of membranes rupture (hours) | 0.5 (0.1–2.0) | 0.3 (0.1–2.2) | 0.6 (0.1–3.5) | 0.5 (0.1–2.7) |
| C-section delivery (%) | 28.9 | 31.3 | 31.7 | 30.6 |
| Among C-section, % before onset of labor and rupture of membranes | 43.6 | 52.5 | 44.4 | 46.8 |
| Median CD4 count (IQR) (cells/mm3) | 533 (400–728) | 515 (401–681) | 558 (434–679) | 552 (414–689) |
| Median Viral load (IQR) (log10 copies/mL) | 3.7 (3.0–4.2) | 3.5 (3.1–4.0) | 1.6 (1.3–2.0) | 3.1 (1.9–3.8) |
| Characteristics of live-born infants
|
NVP-NVP (N=134)
|
Infant-only NVP (N=130)
|
LPV/r (N=143)
|
All (N=407)
|
|---|---|---|---|---|
| Male sex (%) | 49.3 | 53.1 | 46.2 | 49.4 |
| Median Birth weight (IQR) (kg) | 3.0 (2.7–3.3) | 3.0 (2.8–3.3) | 2.9 (2.6–3.2) | 3.0 (2.7–3.3) |