Table 1.
Clinical, laboratory, immunological, and surrogate parameter (mean ± standard deviation) determined at the beginning and the end of the treatment period with PMPDAP. Changes on day 42 between both groups were compared by Mann Whitney U-test for clinical parameter and by Student’s t-test for laboratory parameter (P ≤ 0.05)
| PMPDAP | Placebo | P | |||||
|---|---|---|---|---|---|---|---|
| Day 0 | Day 42 | P | Day 0 | Day 42 | P | PMPDAP vs placebo (day 42) | |
| Clinical parameter | |||||||
| Karnofsky’s score (%) (score 0–100) | 72.0 ± 14.0 | 83.0 ± 12.5 | 0.084 | 83.0 ± 17.0 | 82.0 ± 19.3 | 0.814 | 0.938 |
| Conjunctivitis (score 0–10) | 2.0 ± 0.9 | 1.2 ± 1.3 | 0.129 | 1.9 ± 2.1 | 1.7 ± 2.0 | 0.938 | 0.455 |
| Stomatitis (score 0–10) | 4.0 ± 3.1 | 3.0 ± 2.4 | 0.400 | 1.2 ± 1.2 | 1.1 ± 1.2 | 0.874 | 0.074 |
| Body weight (kg) | 4.8 ± 1.4 | 4.5 ± 1.2 | 0.626 | 4.5 ± 1.0 | 4.3 ± 0.8 | 0.690 | 0.376 |
| Laboratory parameter | |||||||
| Packed cell volume (%) (29.3–49.8 %) | 36.8 ± 5.9 | 31.7 ± 6.8 | 0.089 | 37.3 ± 5.5 | 36.4 ± 3.7 | 0.672 | 0.070 |
| Haemoglobin (g/dl) (9.0–15.6 g/dl) | 11.7 ± 2.3 | 10.5 ± 2.5 | 0.254 | 12.6 ± 2.1 | 12.2 ± 1.6 | 0.621 | 0.090 |
| White blood cells (x 103/µl) (4.87–20.10 × 103/µl) | 10.46 ± 4.48 | 9.83 ± 6.03 | 0.794 | 11.05 ± 4.46 | 12.82 ± 8.41 | 0.562 | 0.372 |
| Lymphocytes (× 103/µl) (1.5–7.0 x 103/µl) | 2.75 ± 1.42 | 3.17 ± 2.30 | 0.628 | 3.27 ± 1.31 | 3.79 ± 2.05 | 0.502 | 0.528 |
| Immunologic parameter | |||||||
| CD4+ (× 103/µl) (0–2.87 × 103/µl) | 0.51 ± 0.32 | 0.64 ± 0.53 | 0.547 | 0.63 ± 0.36 | 0.70 ± 0.39 | 0.705 | 0.796 |
| CD4+ (%) (14.7–50.3%) | 20.1 ± 9.5 | 22.1 ± 7.3 | 0.622 | 21.1 ± 8.0 | 20.4 ± 7.5 | 0.857 | 0.640 |
| CD8+ (x 103/µl) (0–1.37 × 103/µl) | 0.79 ± 0.51 | 0.83 ± 0.70 | 0.892 | 0.69 ± 0.41 | 0.81 ± 0.45 | 0.547 | 0.951 |
| CD8+ (%) (7.0–25.8%) | 26.8 ± 10.6 | 23.1 ± 8.7 | 0.403 | 21.1 ± 9.3 | 23.9 ± 10.3 | 0.193 | 0.857 |
| CD4/CD8 (0.4–4.0) | 0.91 ± 0.61 | 1.20 ± 0.83 | 0.429 | 1.18 ± 0.62 | 1.08 ± 0.72 | 0.753 | 0.752 |
| Surrogate parameter | |||||||
| Biopterin serum (nmol/l) (7.2–7.1 nmol/l) | 18.18 ± 7.6 | 17.70 ± 7.17 | 0.888 | 21.53 ± 6.66 | 19.16 ± 11.75 | 0.587 | 0.741 |
| Biopterin urine (nmol/mmol urine creatine) (0–593.2 nmol/mmol urine creatine) | 225.4 ± 126.9 | 219.4 ± 102.9 | 0.667 | 270.4 ± 98.9 | 219.4 ± 117.4 | 0.363 | 0.713 |
| 7-xanthopterin serum (nmol/l) (3.4–18.6 nmol/l) | 16.36 ± 3.25 | 17.03 ± 5.25 | 0.813 | 19.30 ± 6.91 | 17.71 ± 6.47 | 0.601 | 0.590 |
| 7-xanthopterin urine (nmol/mmol urine creatine) (0–1043.5 nmol/mmol urine creatine) | 697.9 ± 277.1 | 691.7 ± 370.1 | 0.971 | 619.9 ± 129.4 | 595.0 ± 217.0 | 0.791 | 0.491 |