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Design :

Endpoint :

• Primary: proportion of patients with HIV-1 RNA < 50 c/mL at W96 (ITT-exposed, previous-failure = failure analysis) ; 80% power to detect a difference of 25% in response rate
• Secondary: lipoatrophy (> 20% loss in limb fat) at W96 ; 70% power to detect a 20% difference in the mean change in limb fat percentage

Baseline characteristics and patient disposition :

• 79% of patients were male
• 65% were white
• Mean age was 38 years
• Mean baseline HIV-1 RNA was 4.9 log10 c/mL
• Patients in the LPV/r group had a higher mean baseline HIV-1 RNA and a higher mean age
• 112 patients (57% in the LPV/r group and 69% in the EFV group) completed their assigned treatment regimen out to week 96
• In the LPV/r group, after a median of 24 weeks, 92 patients (88%) simplified to LPV/r monotherapy

Outcome at week 96 :

HIV-1 RNA level and discontinuation status, by visit, through 96 weeks :

Adverse events :

• Most common (frequency > 5%) moderate or severe adverse events related to treatment
  • LPV/r monotherapy group
    • Diarhoea: 15%
    • Nausea: 14%
  • EFV group
    • Asthenia: 12%
    • Dizziness: 12%
    • Insomnia: 12%
    • Rash: 10%
    • Depression: 6%
• Most frequent grade 3 or 4 laboratory abnormalities
  • LPV/r monotherapy group
    • Total cholesterol > 7.8 mmol/L: 12% ; Triglycerides > 8.5 mmol/L: 7%
    • Amylase > 2 ULN: 6%
  • EFV group
    • Amylase > 5 ULN: 10%
    • ALAT > 5 ULN: 6%