Table 1 Baseline characteristics of the 625 study participants (who did not experience protocol defined virologic failure through to week 48), and univariate associations with suboptimal CD4 response
Characteristics | All women without virologic failure through week 48 (N = 625) | SCR (N = 71) | Non-SCR (N = 554) | Univariate Pvalue | |
|---|---|---|---|---|---|
Age (years) | Median (IQR1) | 33 (28, 38) | 37 (31, 41) | 32 (28, 37) | <.001 |
Screening CD4 (cells/μL) | Median (IQR) | 134 (88, 168) | 127 (80, 163) | 135 (90, 168) | 0.38 |
Baseline CD4 (cells/μL) | Median (IQR) | 132 (88, 177) | 141 (104, 193) | 130 (85, 174) | 0.08 |
<50 | 63 (10%) | 3 (4%) | 60 (11%) | ||
> = 50 | 562 (90%) | 68 (96%) | 494 (89%) | ||
HIV-1 RNA (copies/ml) | Median (IQR) | 5.13 (4.72, 5.53) | 5.00 (4.29, 5.41) | 5.15 (4.77, 5.53) | 0.005 |
CD4/CD8 ratio | Median (IQR) | 0.17 (0.10, 0.25) | 0.19 (0.11, 0.26) | 0.17 (0.10, 0.25) | 0.48 |
BMI (kg/m2) | Underweight:<18.5 | 58 (9%) | 6 (8%) | 52 (9%) | 0.18 |
Normal: 18.5- < 25 | 372 (60%) | 48 (68%) | 324 (58%) | ||
Overweight: 25- < 30 | 123 (20%) | 14 (20%) | 109 (20%) | ||
Obese: > = 30 | 72 (11%) | 3 (4%) | 69 (12%) | ||
Hepatitis B surface antigen | Positive | 35 (6%) | 7 (10%) | 28 (5%) | 0.10 |
Negative | 587 (94%) | 64 (90%) | 523 (95%) | ||
Missing | 3 | 0 | 3 | ||
WHO stage | I | 254 (41%) | 36 (51%) | 218 (39%) | 0.02 |
II | 187 (30%) | 22 (31%) | 165 (30%) | ||
III/IV | 184 (29%) | 13 (18%) | 171 (31%) | ||
SD NVP exposure prior to study entry | Yes | 204 (33%) | 17 (24%) | 187 (34%) | 0.11 |
No | 421 (67%) | 54 (76%) | 367 (66%) | ||
Initial randomized regimen | NVP | 298 (48%) | 38 (54%) | 260 (47%) | 0.32 |
LPV/r | 327 (52%) | 33 (46%) | 294 (53%) | ||
Site | Botswana | 81 (13%) | 8 (11%) | 73 (13%) | 0.001 |
Durban (SA2) | 44 (7%) | 5 (7%) | 39 (7%) | ||
Eldoret(Kenya) | 54 (9%) | 16 (23%) | 38 (7%) | ||
Kericho(Kenya) | 70 (11%) | 6 (8%) | 64 (12%) | ||
Jo’burg3(SA2) | 56 (9%) | 2 (3%) | 54 (10%) | ||
Jo’burg3 (Wits4)(SA2) | 74 (12%) | 8 (11%) | 66 (12%) | ||
Malawi | 50 (8%) | 5 (7%) | 45 (8%) | ||
Uganda | 50 (8%) | 6 (8%) | 44 (8%) | ||
Zambia | 55 (9%) | 10 (14%) | 45 (8%) | ||
Zimbabwe | 91 (15%) | 5 (7%) 86 | (16%) |