NCT00941083Unknown4 期
Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)
Hospital Carlos III, Madrid1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD)
研究概览
简要总结
A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •HIV1 sero-positive using standard diagnostic criteria
- •Plasma viral HIV-RNA below 50 copies/ml within 180 days prior to randomization
- •On therapy with protease inhibitors both ritonavir-boosted or un-boosted for at least 6 months prior to study entry
排除标准
- •Pregnancy or breast feeding
- •Prior use of Integrase inhibitors
- •Alcohol or substance abuse if according to the investigator opinion would interfere with compliance
- •UIse of investigational medications within 30 days before study entry or during the trial
研究组 & 干预措施
RAL QD 800 mg/24 hs
Experimental
干预措施: Raltegravir (Use RAL as a simplification strategy) (Drug)
RAL BID 400 mg/12 hs
Active Comparator
干预措施: Raltegravir (Use RAL as a simplification strategy) (Drug)
RAL BID to QD
Experimental
干预措施: Raltegravir (Use RAL as a simplification strategy) (Drug)
结局指标
主要结局
Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD)
时间窗: 24 weeks
次要结局
- CD4 gains, lipid profile, adverse events,(24 weeks)
- Drug resistance mutations(24 weeks)
- Raltegravir through plasma levels and correlation with virological failure(24 weeks)
研究者
研究点 (1)
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