Table 2.
Immunological and hemostatic parameters
| Parameter | Value for control groupa |
P valueb | Direction of changec | Value for Cox-2i-treated groupa |
P valueb | Direction of changec | ||
|---|---|---|---|---|---|---|---|---|
| Week 0 | Week 12 | Week 0 | Week 12 | |||||
| Markers of chronic immune activation | ||||||||
| CD4 cell count (×106/liter) | 405 (340–490) | 380 (290–470) | 0.37 | 400 (300–550) | 390 (340–540) | 0.66 | ||
| CD8 cell count (×106/liter) | 1,110 (800–1,550) | 1,170 (770–1,740) | 0.59 | 1,320 (920–1,710) | 1,340 (1,150–1,740) | 0.75 | ||
| HIV-RNA level (×103 copies/ml) | 46 (22–190) | 56 (26–120) | 0.06 | ↑ | 36 (17–91) | 41 (29–110) | 0.25 | |
| β2-Microglobulin level (mg/liter) | 3.2 (2.4–4.1) | 3.0 (2.4–3.1) | 0.97 | 2.8 (2.6–3.1) | 2.8 (2.2–3.2) | 0.21 | ||
| IgA level (g/liter) | 3.1 (2.8–3.8) | 3.2 (2.6–4.2) | 0.19 | 3.6 (2.7–4.3) | 2.9 (2.6–3.7) | 0.04 | ↓ | |
| Total IgG level (g/liter) | 21.2 (16.3–22.6) | 19.3 (16.7–26.6) | 0.48 | 18.8 (17.0–20.4) | 19.1 (15.8–20.2) | 0.30 | ||
| IgG2 level (g/liter) | 2.0 (1.5–3.0) | 2.0 (1.6–3.4) | 0.07 | ↑ | 2.8 (2.0–3.4) | 2.6 (1.7–3.0) | 0.06 | ↓ |
| CRP level (mg/liter) | 1.3 (0.8–2.7) | 2.6 (1.3–3.9) | 0.26 | 1.5 (0.7–3.3) | 1.3 (1.2–4.4) | 0.97 | ||
| IL-6 level (pg/ml) | 2.4 (1.8–3.0) | 1.7 (1.4–2.4) | 0.78 | 1.8 (1.5–2.8) | 1.8 (1.2–2.2) | 0.10 | ↓ | |
| sCD14 level (ng/ml) | 1,660 (1,414–1,870) | 1,769 (1,582–1,881) | 0.55 | 1,786 (1,560–1,901) | 1,682 (1,610–1,989) | 0.86 | ||
| LPS level (EU/liter) | 544 (476–616) | 514 (472–528) | 0.55 | 488 (448–584) | 536 (432–600) | 0.63 | ||
| sICAM-1 level (ng/ml) | 290 (238–311) | 288 (263–386) | 0.07 | ↑ | 329 (264–347) | 290 (259–346) | 0.70 | |
| sVCAM-1 level (ng/ml) | 1,171 (1,030–1,452) | 1,311 (1,024–1,430) | 0.51 | 1,242 (923–1,330) | 1,247 (1,143–1,367) | 0.31 | ||
| Lymphocyte subsets | ||||||||
| % B cells | 4.5 (3.5–7.0) | 5.4 (3.6–6.5) | 0.51 | 4.6 (3.5–6.5) | 5.0 (3.5–6.7) | 0.48 | ||
| % CD4+ T regulatory cells | 4.6 (2.8–5.8) | 4.0 (2.4–5.7) | 0.83 | 3.2 (2.7–3.8) | 5.9 (5.0–7.0) | 0.02 | ↑ | |
| Absolute no. of Treg cells (×106/liter) | 19.3 (15.2–22.3) | 20.1 (10.6–23.9) | 0.13 | 11.0 (10.0–22.5) | 22.9 (18.7–27.2) | 0.06 | ↑ | |
| HIV specific responses on CD8+ CD107a+ T cells | ||||||||
| % Gag responses | 0.91 (0.35–2.70) | 1.06 (0.69–2.67) | 0.94 | 2.06 (1.26–3.36) | 0.65 (0.48–1.50) | 0.27 | ||
| % PD-1 on Gag-responsive cells | 87.6 (77.3–90.3) | 87.5 (79.3–94.4) | 0.64 | 86.5 (82.2–94.3) | 75.0 (65.9–90.9) | 0.02 | ↓ | |
| % Env responses | 0.12 (0.09–0.61) | 0.12 (0.03–0.48) | 0.31 | 0.26 (0.11–0.97) | 0.12 (0.04–0.34) | 0.21 | ||
| % PD-1 on Env-responsive cells | 56.7 (40.8–70.8) | 45.3 (25.0–68.8) | 0.52 | 77.5 (62.5–85.7) | 71.7 (48.3–77.8) | 0.09 | ↓ | |
| % Nef responses | 0.86 (0.55–1.98) | 0.85 (0.38–1.30) | 0.31 | 0.87 (0.38–1.70) | 1.21 (0.69–2.25) | 0.53 | ||
| % PD-1 on Nef-responsive cells | 87.1 (64.8–88.7) | 68.4 (65.1–86.7) | 0.12 | 82.0 (76.4–87.5) | 77.9 (56.6–86.1) | 0.14 | ||
| Parameters of coagulation and endothelial damage | ||||||||
| D dimer level (ng/ml) | 266 (178–398) | 332 (222–455) | 0.10 | ↑ | 303 (211–339) | 315 (251–505) | 0.70 | |
| % von Willebrand factor antigen | 123 (96–147) | 129 (103–182) | 0.07 | ↑ | 144 (114–191) | 137 (95–164) | 0.53 | |
a
Data are medians (IQR).
b
By Wilcoxon matched-pair test.
c
The direction of change (up or down) in medians between baseline and the end of the study is listed when the P value is <0.10.