EUCTR2017-003430-85-FI进行中（未招募）1 期
A randomized, open, parallel design study to evaluate the effect on liver fat, adipose tissue and metabolic parameters when switching a protease inhibitor or efavirenz to once daily raltegravir in HIV-infected patients with body mass index over 25 kg/m2 and with at least one metabolic syndrome component. - OBERA
Helsinki University Hospital0 个研究点目标入组 45 人开始时间: 2017年9月29日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- •Written informed consent (IC) obtained
- •HIV-positive adult (over 18 years) subjects currently on stable ART, with no changes in the ART regimens during the past 6 months
- •Current ART includes either a protease inhibitor or efavirenz
- •No documented or suspected resistance to integrase inhibitors or to NRTIs
- •No prior history of virologic failure. Failure is defined as a confirmed plasma viral load > 200 cop/ml measured no less than six months after initiation or modification of therapy
- •Virological blips accepted only if a single viral load measurement has been between 50-200 cop/ml followed by VL < 50 cop/ml without the need to initiate a change in ART and no blip within 12 month window period prior to screening
- •Documented evidence of at least two HIV VL < 50 cop/ml measurements conducted during the past 12 months prior to inclusion: one within 6 months prior to screening
- •HIV VL < 50 cop/ml at screening
- •BMI>25 kg/m2 and at least one metabolic syndrome condition, which are
- •o BP = 130/= 85 mmHg or hypertension medication currently in use or
- •ofasting glucose = 5.6 mmol/l or B-HbA1C > 42 mmol/mol or diabetes medication currently in use or
- •oHDL < 1.0 mmol/l in men and < 1.3 mmol/l in women or triglycerides = 1.7 mmol/l or a cholesterol-lowering regimen currently in use or
- •owaist circumference > 94 cm in men and >80 cm in women (or respective cut off values for non-European ethnic groups as defined by International Diabetes Federation)
- •ultrasound or biopsy proven hepatosteatosis
- •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 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Within 12 month window period prior to screening, one or more HIV VL measurement of >50 cop/ml
- •More than one consecutive HIV VL measurements of > 50 cop/ml in the treatment history after initial viral suppression with ART
- •Chronic hepatitis B or C
- •Daily alcohol consumption = 30 g for men and = 20 g for women
- •Pregnancy or planned pregnancy during the study period
- •Lipid or glucose lowering regimen or hormonal supplement started within 3 months before the planned study start
- •Psychiatric disorder, which prevents a study subject to understand the study protocol
- •Other serious disease, which prevents a study subject to participate in the study
- •For MRI/spectroscopy imaging: metal objects in the body or claustrophobia
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