Objectives of the study: 1. To verify the safety and the efficacy of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to maraviroc + darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping. 2. To collect relevant information about the safety, the immunologic and the economic impact of this strategy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
Maraviroc 300 mg Darunavir 800 mg Ritonavir 100 mg
To continue the assumption of previous HAART
Catholic University of Sacred Heart
Rome, Italy
proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 48 weeks at per protocol analysis, with switch=failure
Time frame: 48 weeks
proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 96 weeks at intention-to treat analysis with missing value=Failure
Time frame: 96 weeks
Time to virological failure at survival analysis
Time frame: 48 weeks
Proportion of patients with at failure X4 tropism viral tropism (RNA or DNA genotyping)
Time frame: 48 weeks
Evolution of CD4 cell- cluster of differentiation 4 cell count during the 96 weeks
Time frame: 96 weeks
Evolution of adherence and quality of life after 24, 48 and 96 weeks
Time frame: 96 weeks
Evolution of maraviroc, darunavir, ritonavir plasma concentrations during the 96 weeks
Time frame: 96 weeks
Evolution of metabolic parameters at 96 weeks
Time frame: 96 weeks
Change of the results of neurocognitive tests at 48 and 96 weeks
Time frame: 96 weeks
Modification of bone density and subcutaneous fat at 48 and 96 weeks
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Time frame: 96 weeks
Modification of Intima-Media Thickness and Flow Mediated Dilation at 48 and 96 weeks
Time frame: 96 weeks
Economic impact of Darunavir/ritonavir+ Maraviroc versus Highly Active Antiretroviral Therapy
Time frame: 96 weeks