RAltegravir Switch STudy: Effects on Endothelial Recovery

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment with HIV-infection with protease inhibitors is associated with high blood lipids and higher chance for cardiovascular complications. The RASSTER study aims to investigate the effect of switching the protease inhibitor lopinavir/ritonavir to raltegravir on vessel wall function and inflammation,and activation of the immune system. we hypothesize that with this intervention these parameters will improve. Since decreased vessel wall function and inflammation are initial steps in the process of atherosclerosis, it is important to know this data when treating HIV-infected patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Lopinavir; Raltegravir Potassium; Ritonavir

Criteria

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

Exclusion Criteria:

• Pregnancy

• Breastfeeding

• Raltegravir hypersensitivity

• Treatment of underlying malignancy

• Renal insufficiency requiring dialysis

• Acute or decompensated chronic hepatitis (Child-Pugh score C)

• Modification of antiretroviral regimen in the previous 3 months