NCT04939311撤回1 期
Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial
Priscilla Hsue, MD1 个研究点 分布在 1 个国家开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in Target-to-background ratio (TBR)
研究概览
简要总结
This study is a double blinded, placebo-controlled, randomized, parallel group study, designed to compare the efficacy and safety of VB-201 80mg taken orally once daily to placebo for anti-inflammation in HIV-infected subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented HIV infection
- •On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
- •CD4 T-cell count > 350 cells/mm3
- •Male or female between the ages ≥ 40 years of age to <≤75
- •Documented cardiovascular disease (
- •Prior myocardial infarction,
- •History of percutaneous coronary intervention,
- •History of coronary artery bypass graft OR
- •Angiographic evidence of >50% stenosis in at least one coronary artery] OR 1 CVD risk factor (T2DM, current smoking, hypertension, dyslipidemia, hsCRP≥2mg/L, family history)
- •TBR of >1.6 of the MDS of the carotid/aorta at baseline. This baseline arterial TBR cutoff excludes the rare individual that lacks appreciable arterial inflammation. It is notable that while 5-10% of uninfected individuals will have lower TBRs, it is rare that an HIV infected individual will fall below this range.
- •Female subjects must either be of non-childbearing potential as defined by menopause with amenorrhea for >2 years, bilateral oophorectomy, or agree to use adequate contraception throughout the study and for at least one month following termination and have a negative pregnancy test at screening prior to the first dose of drug.
- •Males must use at least one method of contraception throughout the study.
排除标准
- •Pregnant/nursing women
- •Uncontrolled hypertension or diabetes requiring insulin
- •AST/ALT or alkaline phosphatase >2x ULN
- •Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma
- •Nephrotic syndrome or eGFR <60 mL/min/1.73m2
- •Cytopenias which include 1) WBC <3.5 x103/uL 2) Platelet <120 x103/uL 3) ANC <1.5 x103/uL, and absolute lymphocytes <0.8 x 103/uL
- •Anemia as fined by <10 g/dL
- •Evidence of tuberculosis infection at screening within 30 days prior to screening.
- •Family history of long QT syndrome, using medication that prolongs QT internal, OR evidence of prolonged QT of >470 msec as evidenced by ECG
- •Acute systemic infection within 30 days
- •On additional immunosuppressant or immunomodulatory therapies
研究组 & 干预措施
VB-201
Experimental
One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
干预措施: VB-201 (Drug)
Placebo
Placebo Comparator
One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Target-to-background ratio (TBR)
时间窗: 1 year (Baseline and Week 52)
Change in Target-to-background ratio (TBR) from baseline to follow-up study at 52 weeks as assessed by Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT)
次要结局
- Change in high sensitivity C-reactive protein (hs-CRP) in mg/L(1 year (Change from baseline to week 24 and baseline to week 52))
- Change in Interleukin-6 (IL-6) in pg/mL(1 year (Change from baseline to week 24 and baseline to week 52))
- Change in soluble cluster of differentiation (sCD163) ng/mL(1 year (Change from baseline to week 24 and baseline to week 52))
- Change in Lipoprotein (a) [Lp(a)] in mg/dL(1 year (Change from baseline to week 24 and baseline to week 52))
- Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2) in ng/mL(1 year (Change from baseline to week 24 and baseline to week 52))
- Change in D-Dimer (ng/mL)(1 year (Change from baseline to week 24 and baseline to week 52))
- Change in Markers of Immune Activation(1 year (Change from baseline to week 24 and baseline to week 52))
- Change in Monocyte Activation(1 year (Change from baseline to week 24 and baseline to week 52))
研究者
Priscilla Hsue, MD
Chief of Cardiology
University of California, San Francisco
研究点 (1)
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