This study evaluates efficacy and safety of rilpivirine as substitutive agent for the nucleosidic backbone of HAART in virologic suppressed patients when combined with cobicistat-boosted darunavir.
HAART is generally based on the combination of three active drugs. Two of them, usually defined the backbone, belong to the nucleosidic analogues class (NRTI). In the last years, drugs of this class have been associated to several long-term adverse events of HAART such as lipoatrophy, cardiovascular diseases, bone and kidney toxicity. Furthermore the need of a triple drug regimen has recently been questioned as maintenance therapy in well controlled chronically treated subjects. In this setting, less drug regimens (LDR) have been proposed. LDR would allow a reduced exposure to drugs and eventually limit drug-drug interactions, drug-related toxicities and would allow treatment simplification so to enhance HAART acceptability, tolerability and persistence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,609
Switch to a dual ART
Antiviral Therapy Unit, Ospedali Riuniti
Bergamo, Italy
clinical response
proportion of patients with HIV-RNA \< 50 copies/ml (FDA snapshot)
Time frame: 24 weeks
Virological response
proportion of patients with HIV-RNA \> 50 copies/ml (FDA snapshot)
Time frame: 24 weeks
clinical response
proportion of patients with HIV-RNA \< 50 copies/ml
Time frame: 48 weeks
Tolerability (number and proportion of AEs)
AEs total, drug related and leading to treatment interruption/change
Time frame: 24 weeks
Tolerability (number and proportion of AEs)
AEs total, drug related and leading to treatment interruption/change
Time frame: 48 weeks
Bone mineral density
change in bone stiffness
Time frame: 24 weeks
Bone mineral density
change in bone stiffness
Time frame: 48 weeks
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