EUCTR2015-004735-12-IT进行中（未招募）1 期
A Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects with HIV and with Hyperlipidemia and/or Mixed Dyslipidemia - BEIJERINCK
AMGEN INC.0 个研究点目标入组 467 人开始时间: 2021年8月3日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 467
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •* Subject has provided written informed consent
- •* Male or female = 18 years of age at signing of informed consent
- •* Known HIV infection with stable HIV therapy for = 6 months prior to randomization and not expected to change during the duration of study participation. Stable HIV therapy is defined as no new agents added and no dose change of any HIV drug within 6 months prior to randomization
- •* Cluster of differentiation 4 (CD4) = 250 cells/mm3 for = 6 months prior to randomization
- •* HIV viral load = 50 copies/mL at screening and = 200 copies/mL for = 6 months prior to randomization
- •* Subject on stable lipid-lowering therapy for = 4 weeks prior to randomization and not expected to change during the duration of study participation.
- •Subjects should be on maximally tolerated dose of statins.
- •* Subject without known clinical atherosclerotic CVD (ASCVD): fasting LDL-C of = 100 mg/dL (2.6 mmol/L) or non-HDL-C of = 130 mg/dL (3.4 mmol/L) as determined by the central laboratory at screening. Subject with known clinical ASCVD: fasting LDL-C of = 70 mg/dL (1.8 mmol/L)
- •or non-HDL-C of = 100mg/dL (2.6 mmol/L) as determined by the centra laboratory.
- •* Fasting triglycerides = 600 mg/dL (6.8 mmol/L) as determined by central laboratory during screening
- •* Subject tolerates screening placebo injection
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •* Subject taking a combination of background lipid-lowering therapy and HIV therapy known to have significant drug-drug interaction
- •* New York Heart Association III or IV heart failure, or last known left ventricular ejection fraction < 30%
- •* Known opportunistic infection/AIDS defining illness (including but not limited to candidiasis of bronchi, trachea, esophagus, or lungs, invasive cervical cancer, coccidioidomycosis, cryptococcosis, chronic intestinal (> 1-month duration) cryptosporidiosis, cytomegalovirus disease (particularly cytomegalovirus [CMV] retinitis), HIV-related encephalopathy, herpes simplex: chronic ulcer(s) (> 28 days duration); or bronchitis, pneumonitis, or esophagitis, histoplasmosis,
- •chronic intestinal (> 28 days duration) isosporiasis, Kaposi's sarcoma, lymphoma, mycobacterium avium complex, tuberculosis, pneumocystis carinii pneumonia, recurrent pneumonia, progressive multifocal leukoencephalopathy, salmonella septicemia, toxoplasmosis of brain, or wasting syndrome due to HIV within 1 year prior to randomization
- •* Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months prior to randomization
- •* Type 1 diabetes,
- •* Uncontrolled hypertension defined as sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg during screening
- •* Subject has taken a cholesterylester transfer protein inhibitor in the last 12 months prior to randomization
- •* Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate < 30 mL/min/1.73 m2 during screening
- •* Persistent active liver disease or hepatic dysfunction defined as Child- Pugh score of C. Stable (in the opinion of the primary investigator and with aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < 5 times upper limit of normal [ULN] and not expected to require new treatment[s] during study) chronic hepatitis C of at least 1 year duration prior to randomization is allowed
- •* Female subject of childbearing potential not willing to use acceptable method(s) of effective birth control during treatment with IP and for an additional 15 weeks after the end of treatment with IP. Female subjects of non-childbearing potential are not required to use contraception
- •during the study and include those who have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or who are postmenopausal.
- •* Female subject is pregnant or breast feeding, planning to become pregnant or planning to breastfeed during treatment with IP and/or within 15 weeks after the end of treatment with IP
- •* Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years prior to randomization
- •* Subject has previously received evolocumab or any other therapy to inhibit PCSK9
- •* Currently receiving treatment in another investigational device or study drug , or < 30 days before randomization since ending treatment on another investigational device or drug study(s) or planning to receive other investigational procedures while participating in this study
- •* Subject has known sensitivity to any of the active substances or their excipients to be administered during dosing, eg, carboxymethylcellulose
- •* Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and invest
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