0% (95% CI −2.5, 6.5). The same difference of 2.0% (95% CI −3.2, 7.1) was obtained with the SNAPSHOT method and TaqMan assay using an LLOQ of 50 copies/mL. The change from baseline to week 24 in CD4 cell count was 39.8 cells/μL in the NVP XR group and 32.5 cells/μL in the NVP IR group. Both treatment groups demonstrated a trend of increasing mean CD4 cell count after week 8, with no difference between the two treatment groups (data not shown). In all, 98% of both treatment groups were exposed to study medication for at least 24 weeks. Adherence was similar between the treatment groups, the mean adherence with NVP XR being 99.6% [standard deviation learn more (SD) 3.3]

and that with NVP IR being 98.6% (SD 3.3). All geometric mean NVP trough concentrations exceeded 3 μg/mL and were stable for both formulations during the reported 24-week period. The ratio of NVP XR to NVP IR trough geometric mean concentration for all visits was 89.7%. The relative bioavailability analysis showed that the NVP

XR to NVP IR trough ratios were between 83.82 and 98.91%, within acceptable limits for week 24 and the geometric mean of all visits. Furthermore, when trough concentrations for the two formulations were compared, no clinically relevant differences were observed by gender, race, region or background ARV therapy. Overall, AEs were observed in 75.6% (223 of 295) of patients in the NVP XR group and in 60.1% (89 of 148) of patients in the NVP IR group (Table 3a). The frequency of AEs of DAIDS grade 3 or 4 severity was similar between Ceritinib the two

treatment groups: 3.7% (11 of 295) for NVP XR- and 4.1% (six of 148) for NVP IR-treated patients. SAEs were recorded in 21 patients altogether, 17 of 295 (5.8%) in the NVP XR group and four of 148 (2.7%) in the NVP IR group, none of which was considered drug related. Investigator-defined study drug-related AEs mafosfamide occurred in 11.9% (35 of 295) and 2.0% (three of 148) of patients, respectively, for the NVP XR and NVP IR treatment groups. Grade 3 drug-related AEs occurred in one patient (0.3%) treated with NVP XR and two patients (1.4%) treated with NVP IR. There were no grade 4 or fatal clinical AEs in either study arm during the 24 weeks of follow-up. Three patients (1.0%) had AEs leading to study discontinuation, all of whom were in the NVP XR group: one patient experienced tachycardia, dry mouth, indigestion, diarrhoea, olfactory intolerance, headache and a sense of impending doom (DAIDS grade 2); one patient had a rash (DAIDS grade 2); and the third experienced dizziness, light-headedness and nausea (DAIDS grade 1). When all the AEs were reviewed, it became apparent that the AEs occurring at numerically higher rates in the NVP XR group compared with the NVP IR group were related to gastrointestinal, general and administration site, nervous, psychiatric, and skin and subcutaneous disorders.