EUCTR2007-001921-86-DE进行中（未招募）不适用
A double-blind, placebo-controlled, parallel-group, multi-center study to investigate the effect of Omacor? (n-3 PUFA) on lipid parameters in HIV infected patients treated with HAART
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 65
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
- •1. Subjects = 18 years of age
- •2. Documented HIV-infection
- •3. On HAART for the last 3 months
- •4. Written informed consent
- •5. Plasma triglycerides values between 200 mg/100 ml and 1000 mg/100 ml
- •6. Fibrate treatment that has been ongoing for at least 3 months prior to randomization is considered acceptable
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Age below 18 years
- •2. Other malign disease
- •3. Subjects assessed to be not compliant with study
- •4. Females must be non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal-ligation or at least one year postmenopausal) or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth-control pills or equivalent injectable contraceptive. The subjects must have been practicing the selected method of birth control for at least 3 months prior to visit 1.
- •5. Subjects taking fish oil capsules 8 weeks prior to inclusion in this study
- •6. Known allergy to fish oil or soy
- •7. Treatment with statins which can not be stopped
- •8. Treatment with oral anti-coagulants
研究者
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