Effect of Atorvastatin on Subclinical Atherosclerosis in Virally-suppressed HIV-infected Patients With CMV Seropositivity: a Randomized Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Carotid intima medial tunica change
研究概览
简要总结
Statin administration is supposed to reduce subclinical atherosclerosis by decreasing LDL cholesterol levels, possibly via lipid-independent anti-inflammatory effect. Its pleiotropic properties also adding beneficial effect against CMV infection.
The investigators plan to study atorvastatin in virally- suppressed HIV-infected patients on stable ART with CMV seropositive and statin-naïve to evaluate the subclinical atherosclerosis changes assessed by carotid intima media thickness (CIMT).
详细描述
Extended description of the protocol, including more technical information
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Subjects with undetectable HIV-RNA, positive anti-CMV, having Framingham Risk Score above 10% with LDL < 130 or under 10% with LDL <160 will undergo thorough medical history and anthropometric examination as the initial data. Patient will be seen for regular clinical follow up as standard of care in the clinic (monthly/ bimonthly). Follow up visit will include clinical and laboratory procedure. At week 24, blood collection procedures and neurocognitive examination procedures will be repeated. At week 48, blood collection procedures, CIMT, FMD, transient elastography with CAP, and neurocognitive examination procedures will be repeated.
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages between 20 to 45 years old
- •Using stable ART at least 1 year
- •Positive IgG CMV
- •Viral load HIV RNA <50 copies / ml
排除标准
- •Undergoing hepatitis C DAA therapy
- •Decompensated cirrhosis or acute liver failure
- •History of coronary artery disease
- •Diabetes mellitus
- •History of of brain infection, epilepsy, stroke
- •History of rhabdomyolysis or myopathy
- •Pregnant or breastfeeding
- •Severe depression
- •Using statin therapy in the past 6 weeks
- •History of statin hypersensitivity
- •Framingham Risk Score above 10% within LDL ≥130
- •Framingham Risk Score under 10% within LDL ≥160
- •Out of Periodontitis Index (Upper right molars, top series, upper left molars, lower right molars, bottom series, lower left molars)
研究组 & 干预措施
Atorvastatin 20 mg
Study pharmacist will make code (A and B) for atorvastatin and placebo, then save the code in safe place. Pharmacist will record each subject as participant received A or B intervention.
干预措施: Atorvastatin - placebo controlled clinical trial (Drug)
Placebo 20 mg
The placebo tablets will be prepared by Cipto Mangunkusumo hospital pharmacist, were composed of starch and were similar to atorvastatin tablets in size, shape, and colour.
干预措施: Atorvastatin - placebo controlled clinical trial (Drug)
结局指标
主要结局
Carotid intima medial tunica change
时间窗: (1) 0-week visit, (2) 48-week visit
Numerical changes (in millimeter) between baseline and 48 weeks. Common Carotid Artery (CCA) intima media thickness measured by using B mode imaging system (Affiniti 70 series), equipped with a linear array transducer \> 7 MHz with minimal compression (\<10:1) and footprint of at least 3 cm. This procedure is operated by certified Cardiologist. Reference Siomva I. Intima-media thickness: appropriate evaluation and proper measurement, described. ESC. May 2015;15:21.
次要结局
- Flow mediated vasodilatation change((1) 0-week visit, (2) 48-week visit)
- Liver steatosis change((1) 0-week visit, (2) 48-week visit)
- Fasting lipid change((1) 0-week visit, (2) 48-week visit)
- Soluble CD14 change((1) 0-week visit, (2) 48-week visit)
- Neurocognitive function change((1) 0-week visit, (2) 24-week visit, (3) 48-week visit)
- Community Periodontal Index (CPI)((1) 0-week visit, (2) 48-week visit)
- beta 2-microglobulin change((1) 0-week visit, (2) 48-week visit)
- High Sensitivity C-Reactive Protein (hsCRP) change((1) 0-week visit, (2) 48-week visit)
- Liver fibrosis change((1) 0-week visit, (2) 48-week visit)
- ICAM-1 change((1) 0-week visit, (2) 48-week visit)
- Vascular Cell Adhesion Molecule-1 (V CAM-1) change((1) 0-week visit, (2) 48-week visit)
研究者
Evy Yunihastuti
Allergy- Immunology Consultant
Dr Cipto Mangunkusumo General Hospital