Design
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Randomisation was stratified by baseline nucleos (t)ides
Objective
- Non inferiority of DRV/r + 3TC at W48: % HIV RNA < 50 c/mL by intention to treat-exposed, snapshot analysis (lower margin of the 2-sided 95% CI for the difference = - 12%, 80% power)
Baseline characteristics and disposition at W48
Efficacy results (HIV RNA < 50 c/mL by ITT-e, snapshot) at W48
Virologic outcome at W48
Virologic failure
- HIV RNA > 50 c/mL in the W48 window
- Discontinuation before W48 due to lack of efficacy
Virologic failure and viral blips
HIV- 1 RNA > 400 c/mL and emergence of resistance
Adverse events, %
Percent mean change in fasting lipids according to NRTI backbone at screen
Mean change in eGFR (Cockroft-Gault), mL/min