Phase IV, open, multicentre and single-arm study. 50 HIV infection naive patients with severe immunosuppression will be recruited to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment.
The patients included in the study will be treated during 48 weeks and will have to perform the selection/basal visit, week 4 visit, week 8 visit, week 12 visit, week 24 visit, week 48 visit and follow up visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Patents treated with elvitegravir (EVG) 150mg / cobicistat (COBI) 150mg / emtricitabine (FTC) 200mg / tenofovir (TAF) 10mg once a day as the first line treatment.
Hospital Costa del Sol
Marbella, Malaga, Spain
H. Ramón y Cajal
Madrid, Spain
H. Clínico San Carlos
Madrid, Spain
H. Doce de Octubre
Madrid, Spain
Hospital Infanta Leonor
Percentage of patients with undetectable plasma viral load
study the effectiveness of the combination of TAF/FTC/EVG-cb
Time frame: Week 48
Proportion of patients with virological failure
Proportion of patients with Plasma viral load of HIV-1 RNA ≥50 copies / mL in the last measurement while the patient receives the treatment in the window period, patients who interrupt the treatment prematurely due to lack / loss of efficacy in which the last viral load was ≥50 copies / mL or in which the antiretroviral treatment was modified before 48 weeks.
Time frame: From basal until week 48
Proportion of patients with virological failure
Proportion of patients who interrupt the treatment prematurely due to absence or loss of efficacy
Time frame: From basal visit until week 48
Proportion of patients with virological failure
Proportion of patients who interrupt the treatment prematurely by others reasons (other than an adverse event, death or loss of effectiveness) and whose last viral load at the time of abandonment was ≥50 copies / mL.
Time frame: From basal visit until week 48
Time to virological suppression
viral load \<50 copies / mL
Time frame: From basal until week 48
Proportion of patients with virological failure while receiving antiretroviral treatment (ART), having previously been suppressed .
virological failure defined by protocol as viral load\> 1000 copies / mL at week 24 or 2 consecutive viral loads\> 50 copies / mL (at least 2 weeks apart)
Time frame: From basal until week 48
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Madrid, Spain
Hospital virgen del Rocío
Seville, Spain
Time to virological failure
Viral load ≥50 copias/mL
Time frame: From basal until week 48
Incidence of genotypic resistance in patients with virological failure
Time frame: From basal until week 48
Changes in viral load
plasma concentration of HIV RNA
Time frame: Weeks 4, 8, 12, 24, 36 and 48
Change in the CD4+ lymphocyte count
Time frame: Week 48
Proportion of patients who have a CD4+ lymphocyte count > 200 cells / μL
Time frame: Week 48
Mean time to reach a CD4 + lymphocyte count> 200 cells / μL
Time frame: From basal until week 48