Skip to main content

Table 1 Baseline Characteristics for Women Eligible for TDF Randomization

From: Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial

  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)
  Malawi 155 (35) 154 (34) 153 (34) 462 (35)
  Zambia 18 (4) 19 (4) 19 (4) 56 (4)
  Uganda 85 (19) 85 (19) 85 (19) 255 (19)
  Zimbabwe 99 (22) 96 (21) 99 (22) 294 (22)
  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)
  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)
  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)
  Clinical stage II 11 (2) 11 (2) 15 (3) 37 (3)
HBsAg Positive 48 (11) 48 (11) 42/445 (9) 138/1337 (10)
  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)
  1. TDF tenofovir disoproxil fumarate, ZDV zidovudine, Q1 1st Quartile, Q3 3rd Quartile, AP antepartum, HBsAg hepatitis B surface antigen, CrCl creatinine clearance