Written informed consent was obtained from all patients. The study protocol was approved by the appropriate committees and authorities and was conducted in accordance with the Declaration Raf inhibitor of Helsinki. The cut-off date for this analysis was when all patients had reached week

192 or had discontinued earlier. Efficacy and safety variables were assessed at screening, at baseline, at 2 weeks, at 4 weeks, then every 4 weeks until week 16, at week 24, and every 12 weeks until week 192 (or earlier discontinuation). The primary population for the efficacy analyses was the ITT population. This was used to test for noninferiority with the TLOVR algorithm being followed to assess virological response (HIV-1 RNA < 50 copies/mL). Response GSK1120212 and loss of response needed to be confirmed and were defined as response/lack of response at two consecutive visits. Intermittent missing values were imputed as responders only if the patient was responding at the preceding and following visits. If noninferiority was established in the study, superiority testing was also to be performed on this population. Efficacy analyses were also performed on the per-protocol (PP) population: all patients who were randomized, who had taken trial medication and who did not take any disallowed antiretroviral medication

as described in the protocol for > 1 week. Noninferiority at week 192 was confirmed if the lower limit of the 95% confidence interval (CI) of the difference between the DRV/r and LPV/r arms was higher than –12%. Superiority

was confirmed if the lower limit of the 95% CI for the difference in treatment response between the treatment arms was greater than 0%. In this study, secondary efficacy variables Thymidine kinase included the percentage of patients with plasma viral load < 400 copies/mL at all time-points. Additional sensitivity analyses were also performed to compare virological response rates. These included: PP-TLOVR; ITT missing=failure (M = F); ITT-TLOVR non-VF-censored (patients are censored out after they discontinued for reasons other than VF); and Food and Drug Administration snapshot, whereby only the last HIV-1 RNA measurement within a window of the assessed time-point was taken into account to determine response. Virological response rates were also analysed by the following subgroups: baseline HIV-1 RNA, CD4 cell count, gender, race, age and viral clade. Statistical analyses were carried out using a logistic regression model adjusted for treatment and stratification factors. Changes in CD4 cell count were analysed using the noncompleter=failure (NC = F) imputation. A modified medication adherence self-report inventory (M-MASRI) questionnaire was used to evaluate patient adherence to treatment up to week 192 or time of withdrawal.