This is an open label randomized clinial trial to evaluate the treatment with darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
249
Darunavir/ritonavir (800/100 mg): QD (quaque die )
Lamivudine (300mg) : QD
Emtricitabine/tenofovir (300/200 mg) or abacavir/lamivudine (600/300 mg): QD
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Proportion of patients with undetectable viral load
Undetectable viral load \<50 copies/ml according to the FDA snapshot algorithm
Time frame: week 48
Proportion of patients with undetectable viral load
Undetectable viral load \< 50 copies/ml according to the FDA snapshot algorithm
Time frame: Week 24
Proportion of patients with viral load < 200 copies/ml
Proportion of patients with viral load \< 200 copies/ml according to FDA snapshot algorithm
Time frame: week 48
Proportion of patients who present viral load ≥ 50 copies /ml one time
Viral load ≥ 50 copies/ml
Time frame: From basal visit until week 48 visit
Proportion of patients who present viral load ≥ 50 copies /ml more tan two times
Viral load ≥ 50 copies /ml
Time frame: From basal visit until week 48 visit
Proportion of patients who maintained viral load < 50 copies/ml in all determinations
Viral load \< 50 copies/ml
Time frame: week 48
Median of change cells CD4/µl count from basal to week 48
CD4/µl
Time frame: week 48
Median of change in triglycerides , LDL-cholesterol, HDL-cholesterol and total cholesterol from basal to week 48
Time frame: week 48
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Hospital Universitario Germans Trias i Pujol
Badalona, Spain
Hospital Clinic
Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario Vall D'Hebron
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Complejo Hospitalario de Huelva
Huelva, Spain
...and 11 more locations
Change in renal function
Change in glomerular filtration
Time frame: week 48
Change in proportion of patients with renal tubular dysfunction
Time frame: week 48