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积极招募
A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV
About
简短的总结
The study is being conducted to determine if cenicriviroc mesylate (CVC) will decrease vascular inflammation as measured by 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) imaging of the aorta.
主要目的
Study Type
Phase
Eligibility
Gender
健康的志愿者
Minimum Age
Maximum Age
入选标准:
- HIV-1感染记录.
- 目前处于稳定状态, continuous NNRTI-based or unboosted INSTI-based ART regimen for ≥48 weeks prior to study entry with no ART interruption longer than 7 consecutive days and with no plans to change ART during the course of the study.
- 筛选低于定量限度的HIV-1 RNA水平.
- All HIV-1 RNA levels within 48 weeks prior to study entry below the limit of quantification.
- CD4+ cell count >200 cells/mm^3 obtained 入学前90天内.
- At least one of the following cardiovascular risk factors (current diagnosis or receiving treatment, 除非指定时间段):
- 临床动脉粥样硬化性疾病(任何血管出现症状性动脉粥样硬化病变)
- Subclinical atherosclerotic disease (coronary artery calcification [CAC] >10 or presence of non-obstructive plaques)
- 糖尿病或糖尿病前期(血红蛋白A1c [HbA1c]≥5.7%) or impaired fasting glucose (documented fasting glucose of >100 mg/dL within 6 months prior to study entry) or insulin resistance (HOMA-IR ≥2.6)在入学前6个月内或以上任何一项化验结果
- Obesity (body mass index [BMI] ≥30 kg/m^2) or enlarged iliac waist circumference (>40 inches in males, >35 inches in females)
- 筛查时高血压病史或血压≥130/80 mmHg
- Elevated LDL cholesterol (fasting LDL of >160 mg/dL; result from sample taken 入学前90天内 can be used)
- Low HDL cholesterol (<40 mg/dL; result from sample taken 入学前90天内 can be used)
- 吸烟(目前是否吸烟)
- Family history of premature CAD (first degree relative with CAD prior to age 55 for male relative and 65 for female relative; participant report is acceptable)
- hsCRP >2.0 mg/L 入学前90天内 without an active infection or acute illness at the time the sample was obtained
- 以下是在研究开始前90天内取得的实验室数据:
- Absolute neutrophil count (ANC) >750/mm^3
- Platelet count >100,000/mm^3
- 天冬氨酸转氨酶(AST) (SGOT)≤5倍正常值上限(ULN)
- 谷丙转氨酶(ALT) (SGPT)≤5倍ULN
- 碱性磷酸酶≤5倍ULN
- 估计肾小球滤过率(GFR)≥60 mL/min/1.73 m^2 as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation
- Pre-entry FDG-PET/CT imaging (within 60 days prior to study entry) that has been deemed:
- 经中央成像核心实验室AND评估可解释
- Without incidental findings that will preclude participation in the study at the discretion of the site investigator
- 没有计划在第24周研究访问前7天接受免疫接种.
- 有生育潜力的研究对象, negative serum or urine pregnancy test 入学前90天内 and prior to starting study treatment at study entry. Reproductive potential is defined as individuals who have reached menarche and individuals who have not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) ≥40 IU/mL or 24 consecutive months if an FSH is not available, 或者没有做过手术绝育(如.g.(子宫切除术、双侧卵巢切除术、输卵管结扎或输卵管切除术).
- 如果参与可能导致怀孕的性活动, willingness of person of childbearing potential to use two forms of contraception while receiving study medication and for 3 months after stopping study medication as required.
- 年龄≥45岁.
- Ability and willingness of participant or legal guardian/representative to provide informed consent.
排除标准:
- 急性冠状动脉综合征, 定义为心肌梗死(MI)或不稳定性心绞痛, 入学前90天内.
- 当前诊断为潜伏性或活动性结核(TB)感染, 既往任何未经治疗的结核感染, 活动性结核病治疗不足, 或潜伏性结核病治疗不足.
- 目前诊断为其他细胞内病原体(鸟分枝杆菌复合体), 单核细胞增多性李斯特氏菌, 刚地弓形虫, 和新生隐球菌)在研究开始前90天内.
- Untreated hepatitis B virus (HBV) infection with detectable HBV DNA within 6 months prior to study entry.
- 目前丙型肝炎病毒(HCV)感染(1).e.在研究开始前6个月内检测到HCV RNA).
- Acute or clinically significant infection or illness requiring IV antibiotics or hospitalization 入学前90天内.
- History of cirrhosis with severe hepatic impairment and/or hepatic decompensation including ascites, 肝性脑病, 或者静脉曲张出血.
- 活动性恶性肿瘤，鳞状细胞皮肤癌除外.
- Hemoglobin A1c >8% 入学前90天内 by any laboratory that has a CLIA certification or its equivalent, or at any network-approved non-US laboratory or clinic that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
- Initiation of statin therapy or change in statin dose 入学前90天内.
- 目前使用的任何他汀类药物的剂量:
- Atorvastatin, >40 mg/day dose
- 瑞舒伐他汀，≥20mg /天
- 在研究过程中预期添加任何降脂药物.
- Concurrent use of drugs with potential drug-drug interactions with CVC 入学前90天内.
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
- Treatment within 30 days prior to study entry or anticipated treatment with immunomodulating agents (such as systemic corticosteroids, 白细胞介素, interferons, 环孢霉素, 和他克莫司).
- 入境前FDG-PET/CT成像前7天内免疫接种.
- 放射治疗史.
- 入境前一年内受高辐射照射, defined as having undergone more than two of any of the procedures below (includes having undergone the same procedure twice within one year prior to study entry):
- Coronary artery catheterization with or without percutaneous coronary intervention (PCI)
- 心肌灌注应激试验
- 冠状动脉CT血管造影
- 胸部和腹部的CT
- 钡灌肠
- 目前怀孕, 母乳喂养, or planning to become pregnant during the length of the study and three months after completing the study.
- Body weight >300 pounds or >136 kilograms.
- 积极的药物或酒精使用或依赖, 根据现场调查员的意见, 会影响对研究要求的遵守吗.
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Study Stats
Protocol No.
23-5014
Category
心/心血管疾病
传染病
首席研究员
Contact
Location
- 皇冠hga025大学贝弗利山庄分校