One Arm, Open Label, Interventional, Non-comparative Study to Assess Changes in Lipids and Lipoproteins in HIV Infected Women With Hyperlipidemia After Switch From Boosted Protease Inhibitor to Raltegravir
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction
研究概览
简要总结
This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.
This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV infected women from a PI based regimen to raltegravir.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Documented HIV-1 infection in female patients, age ≥18 years
- •Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) for at least the previous 6 months
- •Plasma HIV viral load <50 copies/ml on current boosted PI containing regimen for ≥ 6 months prior to study entry
- •Fasting LDL cholesterol >130 mg/dl
- •Fasting triglycerides <450 mg/dl
排除标准
- •History of virological failure during previous antiretroviral therapy
研究组 & 干预措施
Raltegravir
Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.
干预措施: Raltegravir (Drug)
结局指标
主要结局
Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction
时间窗: baseline to week 12
A reduction of \> 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or \> 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.
次要结局
- Total Cholesterol Baseline and After 24 Weeks(baseline to week 24)
- Triglycerides Baseline and After 24 Weeks(baseline to week 24)
- High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks(baseline to week 24)