Secondary endpoints were the proportion of patients

maintaining an undetectable viral load below 50 HIV-1 RNA copies/mL (in centres with an ultrasensitive assay), time to virological failure, changes in CD4 T-lymphocyte count, the frequency and severity of clinical and laboratory adverse events, withdrawals because of adverse events, change from baseline in fasting lipid values (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides), glucose levels, the degree of adherence as reported by the patient and perceived quality of life/treatment satisfaction. Effectiveness was measured according to the following final events. Virological failure: detectable viral loads confirmed in at least two consecutive determinations separated see more by 1 month were considered as failures. A sample size of 144 participants provided a power of at least 80% to establish 85% effectiveness with a precision of 6% (79–91%) and an alpha of 5%. The primary analysis of effectiveness and safety was performed in all study patients who received at least one dose of ATV. The baseline characteristics of the participants were analysed

using descriptive statistics. Final events and missing study data were considered failures [intent-to-treat (ITT) analysis]. Bivariate and multivariate analyses were performed to study the factors associated with failure. Variables were included in the logistic regression model according to their significance in the bivariate analysis. Analysis of time to virological failure and time to treatment failure was performed using Kaplan–Meier survival www.selleckchem.com/products/FK-506-(Tacrolimus).html curves. For lipid parameters, Beta adrenergic receptor kinase data were censored after any change in lipid-lowering agents. The analysis performed was based on the last on-treatment observation carried forward (LOCF). For laboratory parameter analyses, proportions were compared using the χ2 test or phi coefficient as appropriate. Median baseline and 12-month values were compared using nonparametric

tests for related samples (Wilcoxon test). Adherence to treatment and patient satisfaction were measured as proportions. Baseline and 12-month values were compared using the McNemar test. A significance level of P=0.05 was used in all cases. The statistical analysis was performed using spss software (version 14.0; SPSS, Chicago, IL, USA). A total of 183 patients were included in the study and received at least one dose of ATV/r (Fig. 1). Patients were followed for a median of 11.9 months [interquartile range (IQR) 10.9–12.9 months]. Twenty-five patients (14%) did not complete the study; the main reasons were loss to follow-up and patient decision (Fig. 1). Baseline characteristics and ARV drug history are shown in Table 1. The median CD4 T-lymphocyte count was 514 cells/μL (IQR 364–748 cells/μL) and 92% had a viral load<50 copies/mL.