This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
switch from current antiretroviral regimen to raltegravir with tenofovir/emtricitabine as backbone
Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone
Patients will receive raltegravir with tenofovir/emtricitabine; data will be added to those of Tenofovir Emtricitabine Raltegravir arm in a separate longitudinal analysis comparing data at baseline and at 48 weeks. In this separate analysis, data will not be compared to those obtained from the Lamivudine Abacavir Raltegravir arm. The number of patients in this arm is not pre-established.
Policlinico A. Gemelli
Rome, Italy
To verify the persistent control of the virus replication after the simplification to tenofovir+emtricitabine+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any previous virological failure
Time frame: 48 weeks
Time to virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis
Time frame: 48 weeks
Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis
Time frame: 48 weeks
Evolution of CD4 cell count during the 48 weeks of study
Time frame: 48 weeks
Evolution of adherence and quality of life during the 48 weeks of study
Time frame: 48 weeks
Evolution of raltegravir plasma concentrations during the 48 weeks of study
Time frame: 48 weeks
Evolution of metabolic parameters during the 48 weeks of study
Time frame: 48 weeks
Change of the results of neurocognitive tests at 48 weeks of study
Time frame: 48 weeks
Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study
Time frame: 48 weeks
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