Table 1 Baseline Characteristics for Women Eligible for TDF Randomization
|  | TDF-ART (N = 445) | ZDV-ART (N = 447) | ZDV Alone (N = 446) | Total (N = 1338) | |
|---|---|---|---|---|---|
Age at randomization (years) | Median (Q1, Q3) | 26.4 (22.7, 30.4) | 26.6 (23.4, 30.3) | 26.0 (22.3, 29.5) | 26.4 (22.8, 30.1) |
|  | 18–< 30 years | 326 (73) | 324 (72) | 344 (77) | 994 (74) |
|  | 30–< 40 years | 118 (27) | 114 (26) | 99 (22) | 331 (25) |
|  | 40–< 50 years | 1 (< 0.5) | 9 (2) | 3 (1) | 13 (1) |
Race | Black African | 444 (≥ 99.5) | 446 (≥ 99.5) | 444 (≥ 99.5) | 1334 (≥ 99.5) |
|  | Indian | 0 (0) | 1 (< 0.5) | 1 (< 0.5) | 2 (< 0.5) |
|  | Other | 1 (< 0.5) | 0 (0) | 1 (< 0.5) | 2 (< 0.5) |
Country | South Africa | 78 (18) | 80 (18) | 77 (17) | 235 (18) |
| Â | Malawi | 155 (35) | 154 (34) | 153 (34) | 462 (35) |
| Â | Zambia | 18 (4) | 19 (4) | 19 (4) | 56 (4) |
| Â | Uganda | 85 (19) | 85 (19) | 85 (19) | 255 (19) |
| Â | Zimbabwe | 99 (22) | 96 (21) | 99 (22) | 294 (22) |
| Â | Tanzania | 10 (2) | 12 (3) | 12 (3) | 34 (3) |
|  | India | 0 (0) | 1 (< 0.5) | 1 (< 0.5) | 2 (< 0.5) |
AP Period | Period 1 | 33 (7) | 33 (7) | 29 (7) | 95 (7) |
| Â | Period 2 | 412 (93) | 414 (93) | 417 (93) | 1243 (93) |
Weight (kg) | Median (Q1, Q3) | 64.4 (58.0, 75.9) | 64.0 (58.0, 73.0) | 63.0 (57.0, 71.1) | 63.8 (57.6, 73.3) |
CD4 Cell Count (cells/mm3) | Median (Q1, Q3) | 534.0 (432.0, 684.0) | 540.0 (450.0, 660.0) | 529.0 (431.0, 687.0) | 536.0 (436.0, 680.0) |
|  |  < 350 | 2 (< 0.5) | 2 (< 0.5) | 0 (0) | 4 (< 0.5) |
|  | 350–< 400 | 54 (12) | 49 (11) | 63 (14) | 166 (12) |
|  | 400–< 450 | 82 (18) | 59 (13) | 81 (18) | 222 (17) |
|  | 450–< 500 | 45 (10) | 55 (12) | 48 (11) | 148 (11) |
|  | 500–< 750 | 182 (41) | 208 (47) | 182 (41) | 572 (43) |
|  |  ≥ 750 | 80 (18) | 74 (17) | 72 (16) | 226 (17) |
HIV RNA level (copies/mL) | N | 445 | 447 | 444 | 1336 |
Median (Q1, Q3) | 8393.0 (1909.0, 28,454.0) | 7003.0 (1510.0, 28,767.0) | 6247.5 (1471.0, 24,133.0) | 7339.5 (1604.0, 26,729.0) | |
| Â | Below lower limit of quantification (LLQ) of the assay | 19 (4) | 21 (5) | 10/444 (2) | 50/1336 (4) |
|  |  < 400 | 26 (6) | 33 (7) | 45/444 (10) | 104/1336 (8) |
|  | 400–1000 | 28 (6) | 31 (7) | 38/444 (9) | 97/1336 (7) |
|  | 1000– < 10,000 | 165 (37) | 170 (38) | 165/444 (37) | 500/1336 (37) |
|  | 10,000–< 100,000 | 170 (38) | 163 (36) | 153/444 (34) | 486/1336 (36) |
|  | 100,000–< 200,000 | 24 (5) | 14 (3) | 17/444 (4) | 55/1336 (4) |
|  |  ≥ 200,000 | 13 (3) | 15 (3) | 16/444 (4) | 44/1336 (3) |
WHO Clinical Stage | Clinical stage I | 434 (98) | 436 (98) | 431 (97) | 1301 (97) |
| Â | Clinical stage II | 11 (2) | 11 (2) | 15 (3) | 37 (3) |
HBsAg | Positive | 48 (11) | 48 (11) | 42/445 (9) | 138/1337 (10) |
| Â | Negative | 397 (89) | 399 (89) | 403/445 (91) | 1199/1337 (90) |
Gestational age at Randomization (weeks) | N | 445 | 446 | 446 | 1337 |
Median (Q1, Q3) | 26.0 (21.9, 31.1) | 26.1 (21.3, 31.1) | 26.1 (21.0, 31.1) | 26.1 (21.3, 31.1) | |
|  |  < 14 | 2 (< 0.5) | 1/446 (< 0.5) | 1 (< 0.5) | 4/1337 (< 0.5) |
|  | 14–< 28 | 264 (59) | 272/446 (61) | 268 (60) | 804/1337 (60) |
|  | 28–< 34 | 116 (26) | 115/446 (26) | 118 (26) | 349/1337 (26) |
|  |  ≥ 34 | 63 (14) | 58/446 (13) | 59 (13) | 180/1337 (13) |
Calculated CrCl (mL/min) | Median (Q1, Q3) | 173.2 (141.7, 213.9) | 168.0 (140.7, 201.7) | 169.3 (141.6, 202.4) | 170.1 (141.0, 206.1) |
|  |  > 50–60 | 1 (< 0.5) | 0 (0) | 0 (0) | 1 (< 0.5) |
|  |  > 60–80 | 2 (< 0.5) | 2 (< 0.5) | 2 (< 0.5) | 6 (< 0.5) |
|  |  > 80–100 | 5 (1) | 14 (3) | 10 (2) | 29 (2) |
|  |  > 100–120 | 41 (9) | 40 (9) | 30 (7) | 111 (8) |
|  |  > 120 | 396 (89) | 391 (87) | 404 (91) | 1191 (89) |