NCT00312754终止4 期
A Phase IV, One-arm, Open-label, Multicenter Study Evaluating Effect of Treatment Change to Atazanavir/Ritonavir on Brachial Endothelial Function of HIV Infected Patient Receiving Function in HIV Infected Patient Receiving Potent Antiretroviral Combination Therapy
Bristol-Myers Squibb7 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2005年6月最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
研究概览
简要总结
The purpose of this clinical research study is to learn if BMS-232632 administered as Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated vasodilatation (FMD), in HIV-infected patients. The safety of this treatment will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Documented Metabolic Syndrome by at least 3 of the following parameters:
- •Abdominal obesity, assessed by waist circumference (for men >103 cm, for women >88 cm).
- •Triglycerides > 150 mg/dl.
- •HDL cholestrol (for men <40 mg/dl, for women <50 mg/dl).
- •Blood pressure > or equal to 130/85 mm Hg.
- •Fasting serum glucose > or equal to 110 mg/dl.
- •HIV RNA < 50 copies/mL.
- •IP within 3 months prior to selection.
排除标准
- •Treated Metabolic Syndrom
结局指标
主要结局
To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
次要结局
- The change in FMD from ref. value after a 12-wk ATV/RTV treatment period.
- The proportion of pts w/ virologic rebound after a 24-wk ATV/RTV treatment period.
- The proportion of pts w/ metabolic syndrome after a 24-wk ATV/RTV treament period.-
研究者
研究点 (7)
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