NCT02093754已完成不适用
Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients: a European Multicentre Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 7
- 主要终点
- Percentage of steatosis detected by MRI
研究概览
简要总结
This study will allow to assess liver related injuries in HIV patients.
详细描述
This study is a cross-sectional, multicentre study including 7 centres from 3 European countries (Belgium, France, Germany).
The maximum duration of the study for each patient will be 4 months, consisting of:
- a screening visit,
- an inclusion visit to perform the biologic tests and exams necessary for the study, within 1 month after the screening visit,
- a result delivery visit within 1 month after inclusion visit, to disclose results of previous investigations. Patients with one or two non invasive markers suggesting significant fibrosis (≥F2) will be invited for liver biopsy within the next 2 months.
- a "liver biopsy" visit, within 2 months after visit 2, liver biopsy in selected and consented patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥40 years
- •Infection with HIV-1
- •Cumulative exposure to cART for at least 5 years and currently under cART
- •Viral load < 400 copies/mL
- •CD4 count > 100 CD4/mm3
- •Female may be eligible to enter and participate in the study if she:
- •is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
- •is of child-bearing potential with a negative blood pregnancy test at screening visit
- •Informed consent signed prior to any study procedure
- •To be covered by a medical insurance (only for French centres)
- •Presence of:
- •the metabolic syndrome as defined by the most recent international consensus definition (Alberti et al. Circulation 2009) including three components among the following criteria:
- •visceral obesity (waist circumference: Europeans and Africans ≥ 94 cm for men and ≥ 80 cm for women, Americans ≥ 102 cm for men and ≥ 88 cm for women, Asians ≥ 90 cm for men and ≥ 80 cm for women)
- •blood glucose ≥ 1 g/L (5,6 mmol/L) or anti-diabetic treatment,
- •serum triglycerides ≥ 1,5 g/L (1,7 mmol/L) or hypertriglycerides treatment,
- •serum HDL cholesterol < 0,4 g/L (1 mmol/L) for men and < 0,5 g/L (1,3 mmol/L) for women or hypercholesterolemia treatment,
- •blood pressure (Diastolic ≥130 mmHg and/or Systolic ≥ 85 mmHg) or antihypertensive treatment
- •and/or clinical lipoatrophy and/or lipohypertrophy using clinical questionnaires used and validated in previous published studies (ANRS 121 Hippocampe trial),
- •and/or chronic elevated transaminases ≥ 1.5 ULN and / or GGT ≥ 2 ULN confirmed by two blood samples within at least three-month interval over twelve months prior screening visit.
排除标准
- •Coinfection with hepatitis B (positive HBs antigen or isolated positive HBc antibody with positive PCR)
- •Positive HCV serology
- •Coinfection HIV-1 and HIV-2
- •Use of intravenous drugs within the last six months
- •Excessive alcohol intake (male > 50 g/d, female > 40 g/d)
- •Other causes of liver diseases i.e: viral hepatitis, hemochromatosis, Wilson disease, autoimmune hepatitis, primary or secondary biliary cirrhosis, primary or secondary cholangitis, α1 antitrypsine deficiency
- •Other causes of liver steatosis: current steroid therapy, current therapy with amiodarone, tamoxifen, methotrexate, nifedipine, or hycanthone; history of cancer chemotherapy; short bowel syndrome, polycystic ovarian syndrome, Weber-Christian disease
- •Active opportunistic infection except for candida oesophagitis
- •Current Cancer
- •Decompensated heart failure
- •Subject under legal guardianship
- •Inability to give informed consent or incapacitation
- •Contra-indication to MRI: pace-maker, neurovascular surgery, intraocular materials, cochlear implant, severe claustrophobia
- •Participation in another study with an ongoing exclusion period at screening
结局指标
主要结局
Percentage of steatosis detected by MRI
时间窗: Within 6 months after all patients have completed MRI
次要结局
- Percentage of patients with NASH, fibrosis and cirrhosis on liver biopsy(Within 6 months after all patients have completed the study)
- Percentage of fibrosis or cirrhosis using non invasive markers and concordance of non invasive markers(Within 6 months after all patients have completed the study)
- Risk factors (age, duration of infection, treatment, clinical and biological metabolic and adipose tissue parameters) of liver injuries(Within 6 months after all patients have completed the study)
- Independent risk factors of NAFLD, NASH and fibrosis (including markers of insulin resistance, inflammatory cytokines, markers of immune activation, adipokines)(Within 6 months after all patients have completed the study)
- Establish a diagnosis score based on biomarkers of liver injuries (Adiponectin, leptin, IL6, CRP, CD14)(Within 6 months after all patients have completed the study)
- Description of pathogenetic factors and correlates with autophagy in liver biopsies of patients with evidence for liver fibrosis(Within 6 months after all patients have completed the study)
- Identification of features of the adaptive immune system associated to NAFLD, NASH and fibrosis (T cell activation, surface expression of Treg, NK cells, NKT cells)(Within 6 months after all patients have completed the study)
- Impact of IL28B and PNPLA3 genetic polymorphisms on the severity of liver steatosis, inflammation and fibrosis(Within 6 months after all patients have completed the study)
研究者
研究点 (7)
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