Non-PRO Homework / test English to Spanish Medical Medical (general) SIDA - Clinical Trial - Study design

3 STUDY DESIGN AND EVALUATION

3.1 Study Design

This is a 48 week, observational and descriptive multicenter study designed to compare the treatment response through 48 weeks of a cohort of subjects treated with a LPV/RTV containing regimen after failing a first-line HAART regimen containing ATV and having the I50L mutation (determined at screening) with the response of a cohort of first-line NNRTI (PI-naive) failing subjects receiving a LPV/RTV-containing regimen.

Virologic failure is defined as either having two consecutive HIV RNA determinations of „d 1000 c/mL at least 2 weeks apart or as failure of HIV RNA to fall below 1000 c/mL, after 6 months of treatment (with documented adherence as determined by the investigator).