NCT00120393已完成3 期
A Phase IIIB, Open-label, Randomized, Multi-center Study Evaluating the Effect on Serum Lipids Following a Switch to ATV/r in HIV-1 Infected Subjects Who Have Achieved Virologic Suppression on a LPV/r Based Regimen.
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2004年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.
研究概览
简要总结
Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •HIV positive
- •LPV/RTV-based HAART for at least 6 months
- •HIV-1 RNA less than 50c/mL (confirmed)
- •Non-HDL higher than 160 mg/dL
- •CD4 of at least 50 cells/mL
排除标准
- •Use of lipid-lowering agents
研究组 & 干预措施
G1
Active Comparator
干预措施: atazanavir/ritonavir +2 NRTIs (immediate Switch Group) (Drug)
G2
Active Comparator
干预措施: LPV/r +2 NRTIs (Delayed/optional Switch Group) (Drug)
结局指标
主要结局
To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.
次要结局
- Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.
- Mean change in cholesterol measures at Weeks 12, 24 and 48.
- Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.
- The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.
- The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.
- The proportion of subjects with non-HDL cholesterol less than 160mg/dL at Weeks 12, 24 and 48.
- The frequency and severity of all clinical and laboratory AEs and discontinue for AEs.
研究者
研究点 (1)
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