Table 1. Patient characteristics.
Placebo n = 163 | Prednisolone n = 163 | P value* Placebo vs. Prednisolone | |
---|---|---|---|
Female Sex (%) | 80.4 | 81.0 | P = 0.888 |
Age (years as mean with S.D.) | 35.27 ± 0.70 | 34.09 ± 0.66 | P = 0.221 |
Body mass index (median) [IQR 25%-75%] | 23.44 [20.44–26.11] | 22.15 [20.55–24.70] | P = 0.119 |
CD4 counts (cells/μl, median) [IQR 25%-75%] | 530 [395–659] | 470 [397–598] | P = 0.058 |
females | 531 [394–699] | 484 [398–619.5] | P = 0.0883 |
males | 519.5 [410.3–583.3] | 447 [380–530] | P = 0.2267 |
P value females vs males | P = 0.2638 | P = 0.3436 | - |
CD4/CD8 ratio (median) [IQR 25%-75%] | 0.39 [0.30–0.54] | 0.35 [0.26–0.54] | P = 0.0632 |
females | 0.41 [0.31–0.57] | 0.37 [0.27–0.55] | P = 0.1558 |
males | 0.33 [0.26–0.49] | 0.29 [0.20–0.71] | P = 0.1350 |
P value females vs males | P = 0.0387* | P = 0.0083** | - |
CD4 strata ≥ 500 cells/μl (%) | 57.1 | 44.8 | |
CD4 strata < 500 cells/μl (%) | 42.9 | 55.2 | P = 0.0351§ |
≥ 500 females | 57.3 | 46.2 | |
< 500 females | 42.7 | 53.8 | P = 0.0844§ |
≥ 500 males | 56.2 | 38.7 | |
< 500 males | 43.8 | 61.3 | P = 0.2101§ |
P value females vs males | P = 1.000 | P = 0.5483 | - |
HIV viral load** LOG10 RNA copies/ml (median) [IQR 25%-75%] | 4.35 [3.60–4.81] | 4.22 [3.75–4.95] | P = 0.599 |
females | 4.33 [3.59–4.75] | 4.20 [3.75–4.92] | P = 0.5542 |
males | 4.57 [3.68–4.98] | 4.38 [4.00–5.07] | P = 0.7202 |
P value females vs males | P = 0.3446 | P = 0.3895 | - |
study drug dosage relative to body weight (μg/kg, median) [IQR 25%-75%] | 82.0 [71.4–90.9] | 84.7 [76.9–94.3] | P = 0.0535 |
females | 84.7 [72.5–94.3] | 87.7 [77.2–98.0] | P = 0.0884 |
males | 78.8 [70.4–87.3] | 80.6 [74.6–87.7] | P = 0.3753 |
P value of difference females vs males | P = 0.0868 | P = 0.0193* | - |
*) P-values were determined using Mann-Whitney U-test if not indicated otherwise.
**) Baseline HIV viral load data available from 86 (placebo) and 80 (prednisolone) study participants. Data as LOG10 of RNA copies/ml.
§) p-value calculated from chi square test for strata ≥ 500 cells/μl (%) vs < 500 cells/μl.