NCT00135382已完成3 期
A Phase 3 Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
Bristol-Myers Squibb48 个研究点 分布在 2 个国家目标入组 254 人开始时间: 2002年6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
- 254
- 试验地点
- 48
- 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 protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels < 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.
详细描述
Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.
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 and weight at least 40kg
- •Two plasma HIV RNA levels < 50 copies/mL during the qualification and screening period
- •Patients receiving a PI and ≥ 2 NRTIs
排除标准
- •Pregnancy or breastfeeding
- •Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen
- •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 (48)
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