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Design :

Endpoints: pilot study :

• Primary outcome: proportion of patients with HIV-1 RNA < 500 c/mL at W48 (ITT analysis)
• Secondary outcomes: proportion of patients with HIV-1 RNA < 50 c/mL at W48, time to loss of virologic suppression, development of HIV resistance, CD4 changes, safety, treatment-related adverse events

Baseline characteristics and patient disposition :

Virologic outcome :

Other outcomes :

• 4 blips in the monotherapy group vs 1 in the triple therapy group
• No significant changes in CD4 cell count in any group at W48
• Median adherence was 96% in the triple therapy group and 86% in the monotherapy group (p = 0.09)
• Loss of virologic suppression was associated with shorter time of HIV-1 RNA < 50 c/mL prior to monotherapy (median of 40 weeks vs 132 weeksin patients with maintenance of virologic suppression ; p = 0.02)
• Patients with loss of virologic suppression on LPV/r monotherapy were safely reinduced with prior NRTIs and achieved HIV-1 RNA < 50 c/mL
• Grade 3 hypertriglyceridemia occurred in 3 patients in the triple therapy arm vs none in the monotherapy arm. One patient in each arm had grade 3 hypercholesterolemia