NCT01010399已完成4 期
A Pilot, Open-Label Study of Adjunctive Therapy With Lovaza® in Hypertriglyceridemic, HIV-Infected Subjects Who Switched Protease Inhibitor to Once-Daily Lexiva® 1400mg Plus Norvir® 100mg Plus Optimized Background
Felizarta, Franco, M.D.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Proportion of Subjects With Triglycerides <200 mg/dL
研究概览
简要总结
In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result in 30% of patients achieving a reduction in fasting triglycerides < 200 mg /dL while maintaining virologic suppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fasting triglycerides >= 200 mg/dL but <1,200 mg/dL
- •fasting LDL <= 160 mg/dL
- •participation in a lipid-lowering diet and exercise program for at least 28 days
- •treatment with stable HAART consisting of first or second RTV-boosted PI regimen plus optimized background ART for at least 3 months
- •plasma HIV-1 RNA <50 copies/mL
- •CD4+ cell count >50 cells/mm3
- •male subjection testosterone replacement therapy with total testosterone level <= 1 x upper limit of normal
- •female study volunteer must use a form of contraception
- •ability and willing ness to give written informed consent
排除标准
- •any Grade 4 laboratory abnormality
- •currently taking amprenavir or fosamprenavir
- •required a second RTV-boosted PI for reasons of virologic failure
- •atherosclerotic disease risk
- •congestive heart failure (NYHA Class III or IV)
- •uncontrolled hypertension
- •history of pancreatitis
- •active bleeding disorder
- •recent history of significant renal, pulmonary, biliary, hepatic or gastrointestinal disease
- •current diabetes mellitus requiring pharmacological treatment
- •use of systemic cancer chemotherapy; active cancer
- •pregnancy or breast-feeding
- •requirement for any lipid-lowering agent after baseline
- •use of hormonal anabolic therapies, systemic steroids, immune modulators
- •use of anticoagulants, investigational antiretroviral drugs
- •allergy to study drugs
- •active CDC clinical category C event
研究组 & 干预措施
Boosted Lexiva with Lovaza
Experimental
干预措施: Lovaza (Dietary Supplement)
Boosted Lexiva with Lovaza
Experimental
干预措施: fosamprenavir/ritonavir (Drug)
结局指标
主要结局
Proportion of Subjects With Triglycerides <200 mg/dL
时间窗: 24 weeks
次要结局
- Proportion of Subjects With HIV-1 RNA <50 Copies/mL(24 weeks)
研究者
研究点 (1)
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