Table 3. Treatment Effect on Body Composition, Metabolic, Immune Function and Safety Parameters.
| ATV/r | LPV/r | Treatment Effect (ATV/r vs LPV/r) | p-value | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 2wk | 1mo | 2mo | 4mo | 6mo | Baseline | 2wk | 1mo | 2mo | 4mo | 6mo | |||
| Body Composition | ||||||||||||||
| Body weight (kg) | 90.0 ± 14.2 | 89.5±14.3 | 93.1 ± 16.2 | 94.2 ± 19.7 | 94.2 ± 18.5 | 92.2 ± 19.0 | 86.3 ± 4.4 | 86.7±5.1 | 86.1 ± 4.5 | 85.8±4.3 | 85.2 ± 4.5 | 85.7 ± 4.5 | -1.2 ± 0.7 | 0.10 |
| DEXA % Body Fat | 26.2 ± 2.1 | - | - | - | - | 23.4± 3.2 | 23.0 ± 2.7 | - | - | - | - | 24.1 ± 3.0 | -3.3 ± 2.3 | 0.23 |
| VAT (cm2) | 116 ± 17 | - | - | - | - | 91 ± 15 | 159 ± 21 | - | - | - | - | 167 ± 23 | -31 ± 11 | 0.047 |
| SAT (cm2) | 322 ± 84 | - | - | - | - | 205 ± 41 | 229 ± 48 | - | - | - | - | 242 ± 51 | -41 ± 33 | 0.29 |
| Thigh SC fat (cm2) | 89 ± 19 | - | - | - | - | 87 ± 23 | 56 ± 11 | - | - | - | - | 64 ± 12 | -15 ± 11 | 0.24 |
| Glucose Parameters | ||||||||||||||
| Thigh muscle glucose uptake by PET (μmol/kg/min) | 13.0 ± 4.9 | - | - | - | - | 26.7 ± 5.7 | 26.7 ± 5.9 | - | - | - | - | 24.4 ± 7.9 | 18.2 ± 5.9 | 0.035 |
| Fasting gluc (mg/dL) | 87 ± 3 | 73 ± 4 | 78 ± 4 | 78 ± 6 | 82 ± 5 | 84 ± 3 | 87 ± 4 | 100 ± 12 | 98 ± 10 | 96 ± 8 | 93 ± 9 | 90 ± 8 | -15 ± 4 | 0.002 |
| M/I LBM (μmol/kg/min per μu/mL insulin × 100) | 60.7 ± 20.1 | 187.5±146.9 | 39.0 ± 7.9 | 105.7 ± 41.9 | 61.7 ± 18.1 | 49.2 ± 8.5 | 94.9 ± 56.2 | 0.12 | ||||||
| Lipid Parameters | ||||||||||||||
| Triglycerides (mg/dL) | 302 ± 134 | 171 ± 14 | 159 ± 21 | 161 ± 10 | 109 ± 16 | 147 ± 41 | 283 ± 61 | 383±155 | 293 ± 88 | 369±155 | 337 ± 172 | 209 ± 33 | -182 ± 64 | 0.02 |
| Total cholesterol (mg/dL) | 215 ± 12 | 213 ± 18 | 197 ± 18 | 194 ± 12 | 201 ± 16 | 171 ± 10 | 182 ± 10 | 195 ± 17 | 193 ± 11 | 194 ± 14 | 192 ± 14 | 178 ± 6 | -23 ± 8 | 0.01 |
| HDL (mg/dL) | 42 ± 4 | 45 ± 4 | 42 ± 7 | 46 ± 5 | 47 ± 7 | 42 ± 4 | 36 ± 4 | 41 ± 6 | 38 ± 4 | 37 ± 3 | 41 ± 4 | 36 ± 3 | 1 ± 2 | 0.54 |
| LDL (mg/dL) | 128 ± 8 | 133 ± 15 | 126 ± 10 | 124 ± 10 | 130 ± 10 | 106 ± 8 | 94 ± 12 | 92 ± 14 | 104 ± 11 | 106 ± 13 | 100 ± 12 | 103 ± 9 | -5 ± 6 | 0.44 |
| Non-HDL Cholesterol (mg/dL) | 173 ± 9 | 168 ± 17 | 156 ± 15 | 148 ± 12 | 154 ± 13 | 129 ± 6 | 147 ± 10 | 154 ± 16 | 156 ± 12 | 157 ± 13 | 151 ± 15 | 142 ± 6 | -25 ± 8 | 0.007 |
| Immune Function | ||||||||||||||
| CD4 count (th/mm3) | 417 ± 70 | - | 402 ± 88 | 478 ± 92 | 475 ± 135 | 432 ± 86 | 623 ± 66 | - | 593 ± 66 | 617 ± 78 | 734 ± 70 | 688 ± 87 | 12 ± 34 | 0.72 |
| Viral load (Log10 copies/mL) | 0.5 ± 0.3 | - | 0.7 ± 0.7 | 0.0 ± 0.0 | 0.0 ± 0.0 | 0.0 ± 0.0 | 0.6 ± 0.4 | - | 0.6 ± 0.4 | 0.4 ± 0.4 | 0.0 ± 0.0 | 0.8 ± 0.8 | -0.2 ± 0.2 | 0.31 |
| Safety Parameters | ||||||||||||||
| ALT (U/L) | 55 ± 9 | 71 ± 9 | 65 ± 5 | 58 ± 8 | 68 ± 15 | 61 ± 13 | 60 ± 10 | 55 ± 8 | 48 ± 7 | 50 ± 9 | 59 ± 13 | 65 ± 13 | 16 ± 4 | 0.004 |
| AST (U/L) | 43 ± 8 | 40 ± 8 | 44 ± 7 | 36 ± 7 | 61 ± 32 | 39 ± 13 | 38 ± 10 | 31 ± 6 | 33 ± 12 | 29 ± 7 | 42 ± 15 | 42 ± 11 | 7 ± 6 | 0.22 |
| Total bilirubin (mg/dL) | 0.7 ± 0.1 | 2.1 ± 0.5 | 3.2 ± 0.9 | 3.2 ± 1.3 | 1.8 ± 1.0 | 2.8 ± 1.2 | 0.5 ± 0.1 | 0.5 ± 0.1 | 0.5 ± 0.1 | 0.6 ± 0.1 | 0.6 ± 0.1 | 0.6 ± 0.1 | 1.7 ± 0.3 | 0.0002 |
Mean ± SEM for each treatment group at each study visit. For variables measured only at baseline and 6 months, treatment effect and p-value determined by Student's t-test for normally distributed variables. For all other variables, measured at multiple time points, treatment effect equal to the net difference between the treatment groups over time and p-value determined from repeated measures ANCOVA. All baseline comparisons P>0.05 between groups except for CD4, P=0.05 and LDL, P=0.03. VAT is visceral adipose tissue; SAT is subcutaneous adipose tissue. Thigh SC fat determined by cross-sectional CT scan.