Table 4.
| Variable | Treatment | n Median (Q1-Q3) | P-valued | |||||
|---|---|---|---|---|---|---|---|---|
| Baseline | LOCFc | Delta | ||||||
| CD4 (cells/uL) | SBI | 25 | 308 (251–367) | 24 | 385.50 (298–445) | 24 | 25.50 (-0.50–125) | 0.002 |
| CD4/CD8 | SBI | 25 | 0.38 (0.24–0.53) | 24 | 0.33 (0.27–0.57) | 24 | 0.01 (-0.06–0.06) | 0.848 |
| I-FABP (ng/μL) | SBI | 25 | 1.81 (0.99–2.40) | 24 | 1.46 (0.90–2.15) | 24 | -0.35 (-0.78–0.30) | 0.244 |
| Zonulin (ng/μL) | SBI | 25 | 35.42 (31.35–48.07) | 24 | 34.08 (26.74–38.79) | 24 | -1.93 (-15.89–4.63) | 0.274 |
| Flagellin (ng/μL) | SBI | 25 | 5.04 (2.53–7.17) | 24 | 4.78 (3.04–5.86) | 24 | -0.57 (-2.06–0.94) | 0.122 |
| sCD14 (ng/μL) | SBI | 25 | 1.78 (1.40–2) | 24 | 1.69 (1.40–1.94) | 24 | 0.01 (-0.30–0.25) | 0.825 |
| IL-6 (pg/μL) | SBI | 25 | 1.51 (0.65–2.74) | 24 | 0.77 (0.06–1.73) | 24 | -0.57 (-1.26–-0.16) | 0.001 |
a
Analysis population = Participants receiving SBI for 24 weeks and participants crossing-over from PBO to SBI after week 4
b
Analysis subpopulation = participants in first CD4+T-cell quartile ranges were as follows: Q1: ≤418 (cell/uL) at baseline. Q2-Q4 are: > 418 to ≤ 630, > 630 to ≤ 893, and > 893, respectively
c
Last observation carried forward, to 24 weeks for SBI-treated group and to 20 weeks for PBOSBI cross-over group
d
Wilcoxon Signed-Rank test.
Abbreviations: SBI, Serum-derived bovine immunoglobulin/protein isolate; LOCF, Last observed carried forward; I-FABP, intestinal fatty acid binding protein; sCD14, soluble CD14