001) and 0.9 kg (IQR –0.51 to +2.34 kg) in the

darunavir/r triple-therapy group (P = 0.001), with no significant difference BTK inhibitors between the groups (P = 0.40; Fig. 3). Overall, patients gained a median of 6.3% (IQR –5.4 to +25.0%) and 12.5% (IQR –1.9 to +28.0%) trunk fat, respectively, in the monotherapy and triple-therapy groups. An increase in trunk fat of > 20% over 96 weeks was observed in 37% of patients (22 of 59) in the darunavir/r monotherapy arm and in 34% of patients (24 of 70) in the darunavir/r triple-therapy arm. In contrast to fat tissue modification, no significant change in the squelettic mass index (SMI) was observed in either group during the study period. Linear regression analyses by ITT were performed to assess baseline factors associated Selleckchem JQ1 with the changes in limb fat and trunk fat at weeks 48 and 96. In the multivariate analysis, no baseline variable, such as prior antiretroviral regimen (PI-containing regimen vs. non-PI-containing regimen), NRTI association or body composition, was significantly associated with limb or abdominal modification as measured by DEXA. A significant median change in body weight was observed between baseline and week 96, with a weight gain of +2.0 kg (IQR –1.0 to +4.0 kg) (P < 0.001) in the darunavir/r monotherapy group and +0.5 kg (IQR –2.50 to +3.0 kg) (not significant) in the darunavir/r triple-therapy group, with a significant difference between the two

groups by week 96 (P = 0.012). Significant median changes in body mass index and waist circumference were also found within the two arms, but there were no significant differences between the arms in body mass index or thoracic, waist, hip or thigh circumference. Table 2 summarizes changes in metabolic parameters from baseline to week 96. No significant changes were observed within and between treatment groups with regard to total cholesterol, HDL cholesterol and LDL cholesterol. The only significant difference was increased glucose levels in the darunavir/r

monotherapy arm (median +4.0 mg/dL; IQR –4.0 to +7.0 mg/dL) compared with the darunavir/r triple-therapy group (median –2.0 mg/dl; IQR –5.0 to +4.0 mg/dL) (P = 0.012). However, blood glucose level remained < 126 mg/dL in all patients except Ureohydrolase for one in the darunavir/r monotherapy arm. Bone mineral density of the lumbar spine and both hips was evaluated at week 96 in 87 patients: 50 from the triple-therapy group and 37 from the monotherapy group. Overall, osteoporosis was observed in 11 of 87 patients (12%) and osteopenia in 32 of 87 patients (37%), with no difference between groups. Serum 25-hydroxyvitamin D, PTH, calcium and phosphate levels were similar in the two groups, with median levels of 22 ng/ml (IQR +16 to +28) for 25-hydroxyvitamin D, 47.3 pg/ml (IQR +35.7 to +63.5) for PTH, 2.3 mmol/L (IQR +2.3 to +2.4) for calcium, and 1.0 mmol/L (IQR +0.8 to +1.1) for phosphate.