Phase IIb pilot study for the evaluation of the safety and the feasibility of treatment simplification to tenofovir+emtricitabina+raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological control and toxicity to the current combined antiretroviral regimen.

INTERVENTION:

Trade Name: ISENTRESS Pharmaceutical Form: Tablet INN or Proposed

INN:

Raltegravir Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐

CONDITION:

HIV ; MedDRA version: 12.0 Level: HLT Classification code 10038997 Term: Retroviral infections

PRIMARY OUTCOME:

Main Objective: 1) To verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabina + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies Primary end point(s): proportion of patients with virological failure (two consecutive HIV‐RNA levels > 50 copies/mL or a single value >1000 copies/mL) within 48 weeks at intention‐to.treat analysis Secondary Objective:  Time to virological failure (two consecutive HIV‐RNA levels > 50 copies/mL or a single value >1000 copies/mL) at survival analysis;  Proportion of patients with viral load lower than 50 copies/mL at 48 weeks at the intention to treat analysis;  Evolution of CD4 cell count during the 48 weeks of study;  Evolution of adherence and quality of life during the 48 weeks of study;  Evolution of raltegravir plasma concentrations during the 48 weeks of study;  Evolution of metabolic parameters during the 48 weeks of study;  Change of the results of neurocognitive tests at 48 weeks of study;  Change of bone density and of adipose tissue by DEXA analysis at 48 weeks of study

INCLUSION CRITERIA:

Patients treated with a combined antiretroviral therapy from at least 1 year Aged 18 years or older With one or more of the following conditions:  Grade 3 or 4 Dyslipidemia  Any Hyperglicemia  Lipodystrophy (patient?s self report, confirmed by physician?s physical examination)  Moderate/severe cardiovascular risk, defined as a calcium score higher than 40 or a Framingham score higher than 10 (estimated 10 years cardiovascular risk: 10%)  Diarrhea (at least 3 emissions of loose stool every day for at least 3 days every week) With at least two HIV‐RNA levels <50 copies/mL on two consecutive determinations at least 3 months apart With CD4 cell count >200 cells/ μL for at least 6 months and absence of any opportunistic infection or AIDS‐related disease during the last year before screening. Who gave informed consent to the participation to the study Are the tri