Table 1. Baseline characteristics.
| Postpartum Randomization Arm | |||||
|---|---|---|---|---|---|
| Maternal TDF-ART (N = 200) | iNVP (N = 198) | Total (N = 398) | P-Value | ||
| Age (years) | Median (Q1-Q3) | 26.3 (23.4–29.5) | 26.7 (23.2–31.3) | 26.5 (23.3–30.2) | 0.73a |
| Country | Malawi | 12 (6%) | 15 (8%) | 27 (7%) | 0.34b |
| South Africa | 24 (12%) | 14 (7%) | 38 (10%) | ||
| Uganda | 85 (43%) | 82 (41%) | 167 (42%) | ||
| Zimbabwe | 79 (40%) | 87 (44%) | 166 (42%) | ||
| Previous PROMISE Component | 1077BA–breastfeeding | 180 (90%) | 180 (91%) | 360 (90%) | 0.60b |
| 1077BL–late presenters | 19 (10%) | 18 (9%) | 37 (9%) | ||
| 1077FA–formula feeding | 1 (1%) | 0 (0%) | 1 (0%) | ||
| PROMISE Antepartum Randomization | # missing (late presenters) | 19 | 18 | 37 | |
| Triple ARV (3TC-ZDV/LPV-RTV) | 87 (48%) | 98 (54%) | 185 (51%) | 0.22b | |
| ZDV+sdNVP+TRV tail | 94 (52%) | 82 (46%) | 176 (49%) | ||
| Weight (kg) | Median (Q1-Q3) | 60.6 (55.1–70.3) | 62.0 (56.0–69.6) | 61.2 (55.7–70.0) | 0.74a |
| Height (cm) | Median (Q1-Q3) | 158.3 (152.7–163.0) | 159 (152–163) | 159.0 (152.5–163.0) | 0.94a |
| BMI (kg/m2) | Median (Q1-Q3) | 24.6 (22.2–28.1) | 24.9 (22.6–27.7) | 24.8 (22.4–28.0) | 0.65a |
| CD4 at Antepartum Screening (cells/mm3) | # missing (late presenters) | 19 | 18 | 37 | |
| Median (Q1-Q3) | 544 (450–707) | 539.0 (434.5–691.5) | 540 (446–701) | 0.31a | |
| CD4 at Postpartum Screening (cells/mm3)c | Median (Q1-Q3) | 683.5 (548.0–873.0) | 665 (542–849) | 671 (544–855) | 0.41a |
| HIV RNA level prior to randomization (copies/ml) | Median (Q1-Q3) | 400.0 (61.5–1314.5) | 400 (142–3182) | 400 (83–2289) | 0.07a |
| Calcium (mg/dL) | # missing | 10 | 9 | 19 | 0.73a |
| Median (Q1-Q3) | 8.5 (8.2–8.9) | 8.6 (8.1–9.0) | 8.5 (8.2–8.9) | ||
| Phosphate (mg/dL) | # missing | 8 | 8 | 16 | 0.97a |
| Median (Q1-Q3) | 3.6 (3.2–4.1) | 3.6 (3.3–4.0) | 3.6 (3.2–4.0) | ||
| WHO Stagec | # missing | 169 | 167 | 336 | |
| Clinical stage I | 30 (97%) | 27 (87%) | 57 (92%) | 0.16 b | |
| Number of years of smokingc | # missing | 142 | 137 | 279 | |
| No history of smoking | 57 (98%) | 61 (100%) | 118 (99%) | ||
| History of alcohol use prior to randomizationc | # missing | 162 | 160 | 322 | |
| Yes | 6 (16%) | 3 (8%) | 9 (12%) | 0.29b | |
| Week 1 DXA Lumbar Spine (g/cm2) | # missing | 6 | 9 | 15 | |
| Median (Q1-Q3) | 0.95 (0.87, 1.01) | 0.93 (0.87, 1.00) | 0.94 (0.87, 1.00) | ||
| Mean (95%CI) | 0.94 (0.93–0.96) | 0.94 (0.92–0.95) | 0.94 (0.93–0.95) | ||
| Standard Dev. | 0.11 | 0.11 | 0.11 | ||
| Week 1 DXA Hip (g/cm2) | # missing | 4 | 10 | 14 | |
| Median (Q1-Q3) | 0.98 (0.90, 1.04) | 0.98 (0.90, 1.05) | 0.98 (0.90, 1.05) | ||
| Mean (95%CI) | 0.98 (0.96–0.99) | 0.98 (0.96–1.00) | 0.98 (0.97–0.99) | ||
| Standard Dev. | 0.11 | 0.12 | 0.11 | ||
aWilcoxon Test;
bChi-Square Test;
cCharacteristics with small sample sizes (for WHO Stage, current and history of smoking, and alcohol use) may have had an evaluation >30 days before randomization. Data for Postpartum Screening CD4 Count were missing for one participant (from iNVP arm).