The primary endpoint was treatment response [viral load (VL) <50 HIV-1 RNA copies/mL]. NVP demonstrated noninferiority to ATZ/r at 48 weeks with 66.8% of NVP and 65.3% of ATZ/r patients achieving the primary endpoint [difference 1.9%; 95% confidence interval (CI) −5.9 to 9.8%] . Each
NVP arm alone also demonstrated noninferiority of NVP compared with ATZ/r on the primary endpoint. Week 48 efficacy and safety primary endpoints have been reported previously in detail elsewhere . Week 48 lipid and cardiovascular risk results from the ARTEN trial are now reported here. The planned analyses for the check details lipid results were on the two NVP arms (combined for greater power) vs. ATZ/r. ARTEN is an ongoing multinational, multicentre, randomized, open-label study, conducted in ARV-naïve HIV-1-infected
patients, that compares the efficacy and safety of (i) NVP 200 mg bid, (ii) NVP 400 mg qd and (iii) AZT/r 300 mg/100 mg qd, all combined with TDF/FTC 200 mg/300 mg qd. A total of 710 patients were Selleckchem GSK1120212 screened, of whom 576 were randomized 1:1:1 to these three treatment arms and 569 actually received treatment. Patients randomized to either NVP dose started out with a 14-day lead-in dose of NVP 200 mg qd. Clinical and laboratory data were collected from baseline to week 48. Blood samples for lipid parameters were taken from all patients at baseline, and at weeks 4, 8, 12, 24, 36 and
48. Changes from baseline in fasting plasma levels of total cholesterol (TC), HDL-c, low-density lipoprotein cholesterol (LDL-c), the TC:HDL-c ratio, apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB), and total triglycerides IMP dehydrogenase (TG) were determined at each of the above-mentioned time-points. LDL-c levels were calculated using the Friedewald formula ; therefore, LDL-c levels in patients with TG >400 mg/dL (or >4.52 mmol/L) were not included as no reliable estimate was possible. The ApoB:ApoA1 ratio was also calculated and lipid parameters were evaluated with regard to the National Cholesterol Education Programme (NCEP) established thresholds . Analyses of fasting lipids over time excluded values obtained after the initiation of lipid-lowering therapy. Change in the estimated cardiovascular risk from baseline to week 48 was determined using the Framingham algorithm . Risk factors applied in the algorithm included gender, age, TC, HDL-c, systolic blood pressure (SBP) and smoking status.