A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of lopinavir-ritonavir to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/ml

INTERVENTION: Trade Name: Isentress Product Name: raltegravir Pharmaceutical Form: Tablet CONDITION: ‐Human Imunodeficiency Virus (HIV) infection ‐Endothelial dysfunction in HIV‐infected patients ‐immune activation in HIV‐infected patients ‐cardiovascular complications in HIV‐infecetd patients ; MedDRA version: 14.0 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 10007541 ‐ Cardiac disorders ; MedDRA version: 14.0 Level: LLT Classification code 10008919 Term: Chronic HIV infection System Organ Class: 10021881 ‐ Infections and infestations ; MedDRA version: 14.0 Level: PT Classification code 10048554 Term: Endothelial dysfunction System Organ Class: 10047065 ‐ Vascular disorders Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: To assess the effect of the switch of lopinavir‐ritonavir to raltegravir on endothelial function. Primary end point(s): Change in flow‐mediated dilatation (FMD) of the brachial artery after 8 weeks of raltegravir treatment as compared to the control group (treatment with lopinavir‐ritonavir) Secondary Objective: ‐To assess the effect of switching lopinavir‐ritonavir to raltegravir on markers of endothelialfunction, immune activation, chronic inflammation, plasma lipids and plasma glucose.; ‐To assess the effect of switching lopinavir‐ritonavir to raltegravir on plasma HIV‐RNA below the cut‐off of 50 copies/ml.; ; Timepoint(s) of evaluation of this end point: 8 weeks SECONDARY OUTCOME: Secondary end point(s): The following secondary endpoints will be measured and compared between treatment and control groups: ; ‐Change in markers of chronic inflammation ; ‐Change in markers of immune activation ; ‐Change in markers of endothelial function ; ‐Changes in plasma HIV‐RNA below 50 copies/ml ; Timepoint(s) of evaluation of this end point: 8 weeks INCLUSION CRITERIA: ‐Age = 18 years ‐HIV‐1 infection ‐Treatment with antiretroviral regimen containing lopinavir‐ritonavir for at least the previous 3 months ‐No other protease inhibitors besides lopinavir‐ritonavir in antiretroviral regimen ‐Subjects must have a minimum period of viral suppression (plasma HIV‐RNA < 50 copies/ml) of 6 months ‐Subjects will not have a history of virological failure on antiretroviral therapy ‐Results of previous resistance testing allowing replacement of lopinavir‐ritonavir by raltegravir ‐CD4+ cell count > 200 cells/µL ‐Signed informed consent 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24