Rosuvastatin to Decrease Residual Immune Activation in HIV Infection

• Status: Unknown status
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Participating countries: France Objectives Principal objective To evaluate, in HIV-1 infected patients receiving effective antiretroviral therapy, the effect of the addition of Rosuvastatin (dose of 20mg/day) for 3 months, on CD8 T cell activation as assessed by the proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR Secondary objectives To evaluate the effect of Rosuvastatin administration on residual CD4 and CD8 T cell activation To evaluate the effect of Rosuvastatin administration on the main serum soluble biomarkers of activation (CRP- HS, D-dimers, IL-6 and soluble CD14) To evaluate the effect of Rosuvastatin administration on CD4 T-cell count and on the CD4/CD8 T-cell ratio To study the relationship between the level of immune activation and the level of residual HIV replication in plasma To study the effect of Rosuvastatin administration on lipid profiles and the correlation between the HDL cholesterol and the CD4/CD8 T-cell ratio To evaluate the tolerance of Rosuvastatin at the dose of 20 mg/day

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Collaborator: Sidaction
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• HIV-infected patients receiving a combination of antiretroviral therapy for at least 24 months, unchanged since at least 18 months, exhibiting plasma HIV-RNA level below 20 copies and circulating CD4 T cell count below 500/mm3

• No indication for a treatment with statins (LDL cholesterol < 4.1 mmol/L under stable diet).

Exclusion Criteria:

• Patients receiving Maraviroc

• Patients receiving immune suppressing drugs

• Ongoing opportunistic, bacterial or viral infection

• CRP ≥ 10 mg/mL

• Co-infection with HCV (except if HCV cure), chronic HBV infection with active replication of HBV

• Indication for a treatment with statins

• Pregnancy

• CPK > 3x Normal values

• ALT or AST > 2x Normal values

• TG > 4 mmol/L

• DFG < 60 mL /min/1.73 m2

• Personal or familial history of genetic muscular disease

• History of muscular or hepatic toxicity with a statin or a fibrate

• Liver disease (TP < 70%).

• Hypothyroidism

• Concomitant treatment with : Kétoconazole, Itraconazole, Ciclosporine, Erythromycine, Cimétidine, Quinidine, Diltiazem, Vérapamil, systemic corticosteroids, Phénobarbital, Phénytoïne, Carbamazépine, Rifampicine, Lansoprazole

• Vaccination during the study