Strategic study of dual-therapy with darunavir/ritonavir and rilpivirine QD versus triple-therapy in patients with suppressed viral load: virological efficacy and evaluation of non-HIV related morbidity.

INTERVENTION: Trade Name: PREZISTA*60CPR RIV 400MG Pharmaceutical Form: Coated tablet INN or Proposed INN: DARUNAVIR CAS Number: 206361‐99‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ Trade Name: Edurant Pharmaceutical Form: Coated tablet INN or Proposed INN: rilpivirina Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ CONDITION: HIV infection. ; MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: To evaluate the virologic efficacy of a maintenance regimen with; RPV+DRV/r in HIV+ subjects with a previous antiretroviral treatment and a full HIV‐RNA suppression. Primary end point(s): HIV+ subjects with HIV‐RNA < 50 cp/mL at week 48 according to the intention‐to‐treat (ITT‐TLOVR) approach. Secondary Objective: • To evaluate VACS index modification in subjects treated in two groups, at Weeks 48; and 96, as compared to the baseline;; • To evaluate differences of markers of tubulopathy (RBP, RBP/creatinine, plasmatic and; urinary phosphate, albuminuria) in two groups at week 12, 48, and 96 as compared to the; baseline; we report urinary RBP abnormalities in some patients treated with tenofovir, in some; studies, and the significance of RBP as an indirect marker of tubular damage;; • To evaluate differences of markers of lipid metabolism (total cholesterol, HDL and LDL cholesterol, triglycerides);; • To evaluate differences of markers of bone metabolism (osteocalcin, CTx) as compared; to baseline;; • To evaluate darunavir and rilpivirine plasma exposure (Ctrough) as a determinant of; virological failure. Timepoint(s) of evaluation of this end point: Week 48. SECONDARY OUTCOME: Secondary end point(s): Safety will be assessed through the number of ACTG grade III and IV in the specified safety parameters. Timepoint(s) of evaluation of this end point: Weeks 12, 48 and 96. INCLUSION CRITERIA: • Adult HIV+ subjects (>18 years old), giving and signing an informed consent; • Any HAART treatment for at least 12 months; • Current treatment with a PI/r‐containing regimen initiated at least 6 months earlier; • HIV‐RNA <50 cp/mL for at least 3 months, without viral blip due to virologic failure at any time; • Any nadir CD4 lymphocytes; • Current CD4 count > 100 cell/uL; • eGFRs >60 mL/min/1,73 m2. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12