Table 1. Enfuvirtide (T20 Wilcoxon test results).
n = 12 Volunteers; all men; mean age 29.2 ± 1.27. Significance was calculated among absolute values. "p value of change" represents the significance between endpoints after Phase 1 and Phase 2. "p value PREs" represents significance between values in basal circumstances. No changes were significant.
| Parameters | CHOL | HDL | LDL | TAG | GLU | mtDNA | Crt | AST | ALT | BIL | PROTp |
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean
PRE Placebo |
181.83 ± 10.9 | 50.45 ± 2.8 | 110.64 ± 7.6 | 85.08 ± 14.6 | 81.00 ± 2.4 | 0.713 ± 0.08 | 1.15 ± 0.03 | 26.08 ± 2.8 | 23.33 ± 1.5 | 0.90 ± 0.10 | 74.50 ± 2.0 |
|
Mean
POST Placebo |
173.17 ± 11.6 | 48.08 ± 2.6 | 108.00 ± 8.9 | 85.25 ± 13.1 | 82.83 ± 2.4 | 0.625 ± 0.07 | 1.14 ± 0.03 | 23.50 ± 1.8 | 21.17 ± 1.3 | 0.97 ± 0.16 | 74.25 ± 1.8 |
|
Mean
PRE T20 |
183.92 ± 13.5 | 48.25 ± 2.2 | 118.33 ± 11.4 | 86.67 ± 10.8 | 82.50 ± 2.0 | 0.620 ± 0.05 | 1.11 ± 0.03 | 23.45 ± 1.9 | 22.27 ± 2.4 | 0.79 ± 0.05 | 74.27 ± 1.9 |
|
Mean
POST T20 |
172.42 ± 10.1 | 49.42 ± 2.6 | 104.42 ± 8.1 | 92.75 ± 13.8 | 84.75 ± 1.7 | 0.682 ± 0.07 | 1.15 ± 0.02 | 23.73 ± 1.5 | 23.64 ± 2.5 | 1.07 ± 0.12 | 74.91 ± 2.1 |
|
Change
Placebo (%) |
−4.77 ± 6.4 | −4.70 ± 5.2 | −2.38 ± 8.0 | 0.20 ± 15.4 | 2.26 ± 3.0 | −12.32 ± 9.6 | −0.72 ± 2.5 | −9.90 ± 6.8 | −9.29 ± 5.8 | 7.41 ± 17.4 | −0.34 ± 2.4 |
|
Change
T20 (%) |
−6.25 ± 5.5 | 2.42 ± 5.4 | −11.76 ± 6.9 | 7.02 ± 15.9 | 2.73 ± 2.0 | 10.02 ± 11.3 | 4.10 ± 2.1 | 1.16 ± 6.3 | 6.12 ± 10.9 | 35.63 ± 14.3 | 0.86 ± 2.7 |
|
p value
change |
0.937 | 0.200 | 0.798 | 0.695 | 0.656 | 0.060 | 0.194 | 0.722 | 0.192 | 0.349 | 0.473 |
|
p value
PREs |
0.695 | 0.075 | 0.211 | 0.784 | 0.594 | 0.239 | 0.334 | 0.893 | 0.422 | 0.177 | 0.503 |
CHOL = Total cholesterol; HDL = High density lipoproteins; LDL = Low density lipoproteins; TAG = Triglycerides; GLU = Glucose; mtDNA = Mitochondrial DNA; Crt = Creatinine; AST = Aspartate aminotransferase; ALT = Alanine transferase; BIL = Bilirubin; PROTp = Total plasma proteins; PRE = Values before starting placebo/T20; POST = Values after starting placebo/T20.