3%) VFs in the DRV/r group and seven (12.3%) in the LPV/r group. Paired baseline/endpoint phenotype data were available for 39 patients in the DRV/r arm and 52 patients in the LPV/r arm. All samples from these patients remained susceptible to DRV, click here LPV, amprenavir, atazanavir, indinavir, saquinavir and tipranavir at endpoint. Of these VFs, four patients in the DRV/r arm (10.5%) and five patients in the LPV/r arm

(9.8%) lost susceptibility to FTC; this was associated with the development of the M184I and/or V mutation. In addition, a loss of susceptibility to TDF was observed in two patients in the DRV/r arm; this was not correlated with the development of NRTI RAMs and may have been a result of assay variation (the endpoint fold-change value was just above the biological cut-off). Table 2 gives an overview of the resistance analysis (including their further genotypic and phenotypic Sirolimus nmr details). 4 (9.3) L10V (n=1); V11I† (n=1); I13V (n=1); I13V + G16E‡ (n=1) 9 (15.8) I13V (n=1); L33V (n=1); M36I (n=1); I62V (n=1); A71V (n=1); A71T + V77I (n=1); V77I (n=1); I93L (n=1) 4 (9.3) M184I/V‡ (n=1); M184V (n=2); M184V + K70E (n=1) 7 (12.3) M184I/V (n=1); M184I (n=2); M184V (n=4) Table 3 summarizes the safety and tolerability findings. At week 192, permanent discontinuation of treatment because of AEs (including pregnancies; nine in the DRV/r group

and six in the LPV/r group) was significantly less frequent in the DRV/r arm (7.6%) than in the LPV/r arm (14.5%) (P = 0.005). Serious AEs regardless of causality were reported in 16.0% of patients in the DRV/r group and 20.8% of patients in the LPV/r group. At week 192, four patients (1.2%) in the DRV/r arm and seven patients (2.0%) in the LPV/r arm died during treatment. Deaths were as a result of: cardiorespiratory arrest; cerebrovascular accident; dehydration and hepatorenal syndrome; lymphoma; road traffic accident; disseminated tuberculosis; diffuse large B-cell lymphoma; drug toxicity;

myocardial infarction and pneumonia; meningococcal meningitis; and one death where the reason was not reported. None of these deaths was considered by the investigator to be treatment related. By week 192, one patient in each treatment arm had reported a serious renal AE (recorded by the investigator as renal impairment), and one patient in the LPV/r arm had discontinued treatment because of a renal AE (decreased http://www.selleck.co.jp/products/Rapamycin.html creatinine clearance). As TDF was included in the background regimen, changes in calculated creatinine clearance were monitored throughout the trial. A similar mean decrease in creatinine clearance was observed for both treatment groups at week 192 [–9.3 mL/min (95% CI –7.6; 28.1 mL/min) and –7.0 mL/min (95% CI −9.30; 4.63 mL/min) for DRV/r and LPV/r, respectively]. The incidence of grade 2–4 abnormalities for creatinine was 1.2% for DRV/r vs. 0.6% for LPV/r. There were 12 reported cases of kidney stones: six in the DRV/r arm and six in the LPV/r arm.