Dataset from Study of Once-Daily Versus Twice-Daily Fosamprenavir Plus Ritonavir, Administered With Abacavir/Lamivudine Once-Daily in Antiretroviral-Naive HIV-1 Infected Adult Subjects.

This is a Phase IIIB, 48 Week, multicentre, randomized, open-label, parallel group study
comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg/100mg once-daily to
fosamprenavir plus ritonavir 700mg/100mg twice-daily, both administered with
abacavir/lamivudine 600mg/300mg once-daily in antiretroviral-naive HIV-1 infected adults.
This study utilizes a group-sequential design with two stages: 1) an interim 24 week cohort
analysis of approximately 200 subjects and 2) if study continuation criteria are met at this
interim analysis, further enrolment of an additional 528 subjects, followed over a minimum of
48 weeks. The objectives of the study are to demonstrate 1) non-inferior antiviral activity
of fosamprenavir/ritonavir 1400mg/100mg QD compared to fosamprenavir/ritonavir 700mg/100mg
BID and 2) a superior fasting non-HDL lipid profile in subjects receiving
fosamprenavir/ritonavir 1400mg/100mg QD.