Comparative, randomized, open study to evaluate maintenance with Darunavir/ritonavir once daily plus Lamivudine once daily versus continuing Darunavir/ritonavir once-daily plus Tenofovir/Emtricitabine (or Abacavir/Lamivudine) in HIV-infected subjects with undetectable plasma HIV viremia for at least six months.DUAL Study.

INTERVENTION:

Product Name: Lamivudina Pharmaceutical Form: Tablet INN or Proposed

INN:

LAMIVUDINE CAS Number: 134678‐17‐4 Trade Name: PREZISTA Product Name: PREZISTA Pharmaceutical Form: Tablet Trade Name: PREZISTA Product Name: PREZISTA Pharmaceutical Form: Tablet Trade Name: NORVIR Product Name: NORVIR Pharmaceutical Form: Tablet Trade Name: NORVIR Product Name: NORVIR Pharmaceutical Form: Tablet Trade Name: TRUVADA Product Name: TRUVADA Pharmaceutical Form: Tablet Trade Name: KIVEXA Product Name: KIVEXA Pharmaceutical Form: Tablet

CONDITION:

HIV chronic infection ; MedDRA version: 17.0 Level: LLT Classification code 10001509 Term: AIDS System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Virus Diseases [C02]

PRIMARY OUTCOME:

Main Objective: To compare safety and efficacy of the dual combination DRV/r qd + 3TC qd versus triple therapy with DRV/r qd + TDF/FTC (or ABC/3TC) in HIV‐infected patients who have maintained at least six months of viral suppression while receiving triple therapy with DRV/r qd + TDF/FTC (or ABC/3TC). Primary end point(s): Proportion of patients with HIV‐RNA levels below 50 HIV‐RNA copies/ml by intention to treat analysis (FDA snapshot algorithm) at week 48. Secondary Objective: To evaluate the safety and tolerability of the dual and triple combinations.; To evaluate the incidence and type of resistance mutations in patients suffering virologic failure. Timepoint(s) of evaluation of this end point: 48 weeks

SECONDARY OUTCOME:

Secondary end point(s): 1. Proportion of patients with HIV‐RNA levels below 50 HIV‐RNA copies/ml by intention to treat analysis (FDA snapshot algorithm) at week 24 ; 2. Proportion of patients with HIV‐RNA levels below 200 HIV‐RNA copies/ml by intention to treat analysis (FDA snapshot algorithm) at week 48 ; 3. Proportion of patients with virologic failure at week 48. ; 4. Percentage of patients with resistance development at week 48 ; 5. Median changes in CD4 cell counts ; 6. Incidence of adverse events and incidence of drug discontinuation due to toxicity or intolerance. ; 7. Median changes in triglycerides, total, LDL‐ and HDL‐cholesterol ; 8. Changes in eGFR ; 9. Changes in proportion of patients with renal tubular dysfunction ; 10. Proportion of resistance genotypic mutations in patients showing virologic failure at week 48. ; 11. Description and frequency of resistance genotypic mutations. Timepoint(s) of evaluation of this end point: 24 weeks ; 48 weeks

INCLUSION CRITERIA:

1. Consent to participate in the study, signing and dating the informed consent. 2. HIV patients > 18 years old. 3. Receiving DRV/r qd + TDF/FTC (or ABC/3TC) for at least 4 weeks. 4. Plasma HIV RNA < 50 cop/ml for at least 6 months (2 tests separated at least 6 months with viremia < 50 cop/ml between both determinations). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 256 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 256