Pilot Study of the Impact of Rosuvastatin Administration on Residual Chronic Immune Activation Under Antiretroviral Therapy: CESAR (Crestor En Sus Des AntiRétroviraux)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- CD8 T cell activation
研究概览
简要总结
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
详细描述
Methodology Phase II pilot study; open-label; non comparative, bicentric, on-off design
Estimated enrolment 40 subjects
Outcomes Primary outcome :
• Variation at month 3 in the proportion of CD8 T lymphocytes co-expressing CD38 and HLA-DR
Secondary outcomes :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Rosuvastatine 20 mg
Rosuvastatin 20 mg/day, once a day during 3 months
干预措施: Rosuvastatin 20 mg/day (Drug)
结局指标
主要结局
CD8 T cell activation
时间窗: 6 months
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
Coexpress activation markers
时间窗: 6 months
proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR
次要结局
- Rosuvastatin administration (on and off)on biomarkers activation(6 months)
- Relationship between the levels of T-cell activation and of plasma HIV-RNA (ultrasensible measure)(6 months)
- CD4 T-cell count and on the CD4/CD8 T-cell ratio(6 months)
- Lipids profiles on and off rosuvastatine association(6 months)
- Tolerance of Rosuvastatine(6 months)