Table 1.
Baseline Demographic and Clinical Characteristics of the Infants and Mothers.*
| Characteristic | Overall (N = 1684)† | Zidovudine (N = 566) | Zidovudine plus Nevirapine (N = 562) | Zidovudine plus Nelfinavir and Lamivudine (N = 556) | P Value‡ |
|---|---|---|---|---|---|
| Infant’s age at time of ART delivery — hr§ | |||||
| Median | 29 | 28 | 29 | ||
| Range | 2–48 | 3–48 | 3–48 | ||
| Inadvertent enrollment: mother HIV-negative on confirmatory testing — no./total no. (%) | 51/1735 (2.9) | 15/581 (2.6) | 18/580 (3.1) | 18/574 (3.1) | 0.83 |
| Maternal age | |||||
| Median — yr | 26 | 26 | 26 | 26 | 0.86 |
| Range — yr | 13–47 | 13–43 | 14–47 | 14–45 | |
| 13–24 yr — no./total no. (%) | 658/1664 (39.5) | 218/563 (38.7) | 207/1230 (37.2) | 233/544 (42.8) | 0.15 |
| 25–29 yr — no./total no. (%) | 470/1664 (28.2) | 166/563 (29.5) | 171/557 (30.7) | 133/544 (24.4) | |
| ≥30 yr — no./total no. (%) | 536/1664 (32.2) | 179/563 (31.8) | 179/557 (32.1) | 178/544 (32.7) | |
| Race — no./total no. (%)¶ | |||||
| Black | 819/1664 (49.2) | 273/563 (48.5) | 283/557 (50.8) | 263/544 (48.3) | 0.50 |
| Mixed | 451/1664 (27.1) | 145/563 (25.8) | 147/557 (26.4) | 159/544 (29.2) | |
| White or other | 394/1664 (23.7) | 145/563 (25.8) | 127/557 (22.8) | 122/544 (22.4) | |
| Viral load — no./total no. (%) | |||||
| >100,000 copies/ml | 226/1656 (13.6) | 71/559 (12.7) | 82/554 (14.8) | 73/543 (13.4) | 0.49 |
| 10,000–100,000 copies/ml | 726/1656 (43.8) | 254/559 (45.4) | 247/554 (44.6) | 225/543 (41.4) | |
| <10,000 copies/ml | 704/1656 (42.5) | 234/559 (41.9) | 225/554 (40.6) | 245/543 (45.1) | |
| Log10 viral load — copies/ml|| | |||||
| Median | 4.17 | 4.17 | 4.20 | 4.13 | 0.29 |
| Range | 1.65–6.78 | 1.65–6.78 | 1.84–6.36 | 1.86–6.49 | |
| CD4+ count | |||||
| Median — cells/mm3 | 459 | 471 | 447 | 458 | 0.83 |
| Range — cells/mm3 | 12–2678 | 31–1748 | 12–2678 | 23–2556 | |
| <200 cells/mm3 — no./total no. (%) | 191/1633 (11.7) | 67/548 (12.2) | 55/546 (10.1) | 69/539 (12.8) | 0.33 |
| 200–350 cells/mm3 — no./total no. (%) | 358/1633 (21.9) | 115/548 (21.0) | 137/546 (25.1) | 106/539 (19.7) | |
| 351–500 cells/mm3 — no./total no. (%) | 358/1633 (21.9) | 115/548 (21.0) | 120/546 (22.0) | 123/539 (22.8) | |
| >500 cells/mm3 — no./total no. (%) | 726/1633 (44.5) | 251/548 (45.8) | 234/546 (42.9) | 241/539 (44.7) | |
| Use of zidovudine during labor — no./total no. (%) | 682/1664 (41.0) | 227/563 (40.3) | 231/557 (41.5) | 224/544 (41.2) | 0.92 |
| Maternal syphilis — no./total no. (%) | 151/1626 (9.3) | 49/549 (8.9) | 56/545 (10.3) | 46/532 (8.6) | 0.61 |
| Timing of maternal diagnosis — no./total no. (%) | |||||
| During labor and delivery with rapid testing for HIV-1 | 1218/1664 (73.2) | 413/563 (73.4) | 413/557 (74.1) | 392/544 (72.1) | 0.73 |
| Before labor, with 2 positive serologic tests | 446/1664 (26.8) | 150/563 (26.6) | 144/557 (25.9) | 152/544 (27.9) | |
| Type of delivery — no./total no. (%) | |||||
| Cesarean before membrane rupture | 395/1683 (23.5) | 132/566 (23.3) | 131/561 (23.4) | 132/556 (23.7) | 0.98 |
| Vaginal or cesarean after membrane rupture | 1288/1683 (76.5) | 434/566 (76.7) | 430/561 (76.6) | 424/556 (76.3) | |
| Gestational age | |||||
| Median — wk | 39 | 39 | 39 | 39 | 0.76 |
| Range — wk | 32–42 | 32–42 | 32–42 | 32–42 | |
| ≥37 wk — no./total no. (%) | 1509/1684 (89.6) | 510/566 (90.1) | 509/562 (90.6) | 490/556 (88.1) | 0.37 |
*
ART denotes antiretroviral therapy.
†
The total number of infants was 1684. Because there were 10 pairs of twin babies, the total number of mothers was 1664.
‡
P values were calculated with the use of Pearson chi-square tests.
§
Two thirds of mothers received standard-of-care treatment with zidovudine before the initiation of the study regimen.
¶
Race was determined by self-report.
||
A viral load of 400 copies per milliliter or less was recorded as 400 divided by the square root of 2.