E mITT Bev Lkerung with the FDA-defined analysis niert Instant, 10, of Effi ciency scores based on a snapshot of the levels of HIV RNA at week 48, and a deficiency that the error analysis. Both analyzes were prespecifi ed. We analyzed the safety data up to week 48 in all patients who again U at least one dose of study medication. her2 Thus, the data security for those who registered early and remained in the study collected over two years and will be included in the report. S analyzes H rte Includes data from up to 30 days after completion of the study drugs. The safety analyzes and judgments were made on a post-hoc. The statistical analysis of available data from other studies, 5.11 13 We calculated that a sample of 700 patients is required to supply 85% power to assess the non-inferiority would be based, the main goal.
We worked on the percentage difference and set the associated two-sided 95% CI differences with Haenszelproportions coat for basic HIV RNA quantity and class of the second agent. We did not feel less elvitegravir to raltegravir, if the lower bound of the 95% diff for the treatment ENCE LY315920 10% or more. We used Fisher exact test to compare the proportion of patients with concentrations of diarrhea and raised in alanine aminotransferase and aspartate aminotransferase. We went for a HIV genotyping and Ph Notypisierung of blood samples at screening for all patients and samples from persons or sub-optimal virological response, virological rebound, HIV RNA of 400 copies per ml or more taken at week 48, but not suboptimal virological response, or HIV-RNA 400 copies per ml or h on her last visit before the drug saying continuous study.
We assigned scores according to genotypic and ph Phenotypic sensitivity fi ndings of the strength test PhenoSense GT. R Of the funding source The sponsor of the study analyzed company Gilead Sciences, a con U-study and the data. All authors had access to data and analysis, contributed to the writing and public Ver, And approved the fi nal report. Mr. J and SLC had the fi nal decision, the report for the Ver Submit ffentlichung. The tests began on 19 Results in June, 2008, and every 48 weeks, the visits were from 15 Completed in December 2010. Was closed at the beginning of the study, a 234 sites by several serious violations of protocol were ten patients taken off on this side of the study and are not included in the glove compartment or protocol analysis.
Patient characteristics, disposition and reference information, and officers were well balanced between treatment groups. Darunavir was the protease inhibitor at the h Ufigsten used, and the second means background was in general a NRTI. Two thirds of the patients had mutations of two or more classes of agents. 207 of 351 individuals in the elvitegravir arm had HIV RNA below 50 copies per ml of 351 against 203 in the raltegravir arm, suggesting the non-inferiority. Effi ciency was similar, if ned calculated using the algorithm defined by the FDA snapshot: 210 assigned to that of those of elvitegravir 202 raltegravir assigned. The per-protocol analysis has produced response rates h Ago as the glove, it was similar in both groups. Similar proportion of patients receiving raltegravir or elvitegravir had a quantity of HIV RNA below 50 copies per milliliter at each follow-up