NCT00135369已完成3 期
A Phase 3 Study Switching HIV-1 Infected Subjects With an Undetectable Viral Load From a HAART Regimen Dosed Twice Daily or More Frequently to a Once-Daily HAART Regimen
Bristol-Myers Squibb47 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2002年9月最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 47
- 主要终点
- Efficacy at week 48
研究概览
简要总结
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels <50 copies/mL after switching to a QD regimen.
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
- •Documented HIV infection
- •18 years of age or older and weigh at least 40 kg
- •Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
- •Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently
排除标准
- •Pregnancy, breastfeeding or plans to become pregnant during the study period
- •Any prior documented virologic failure to one or more HAART regimens
- •Active AIDS-defining opportunistic infection or disease
- •Proven or suspected acute hepatitis within 30 days prior to study entry
结局指标
主要结局
Efficacy at week 48
次要结局
- Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48
研究者
研究点 (47)
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