NCT00116298已完成3 期
A Study to Compare Long-Term Safety and Tolerability of Stavudine (d4T) Extended Release (ER) Versus Conventional (Immediate Release, IR) Formulations, Each In Combination With Lamivudine (3TC) and Efavirenz (EFV) in Subjects Who Have Completed BMS Studies AI455-096 and AI455-099
Bristol-Myers Squibb63 个研究点 分布在 11 个国家目标入组 900 人开始时间: 2001年1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
- 900
- 试验地点
- 63
- 主要终点
- Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period
研究概览
简要总结
The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed d4T studies AI455-096 or AI455-099
- •Have demonstrated compliance with the study medication and treatment visits
- •Provide written informed consent
- •Agree to use a barrier method of birth control (such as condoms) during the study
- •Have a negative pregnancy test within 72 hours prior to start of study medication
排除标准
- •Are pregnant or breast-feeding
- •Need to take certain medications that have systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential
- •Have active alcohol or substance abuse which may prevent compliance or increase risk of developing pancreatitis
- •Have certain other conditions or prior treatments that might interfere with study continuation
- •Need to take certain medications that should not be taken with EFV
结局指标
主要结局
Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period
次要结局
- Efficacy: Changes in CD4 cell counts
研究者
研究点 (63)
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