跳至主要内容
临床试验/NCT00005918
NCT00005918已完成3 期

The Safety and Antiviral Efficacy of Stavudine Extended Release Formulation as Compared to Stavudine Immediate Release Formulation, Each as Part of Potent Antiretroviral Combination Therapy

Bristol-Myers Squibb108 个研究点 分布在 9 个国家目标入组 730 人开始时间: 2000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
730
试验地点
108

研究概览

简要总结

The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).

详细描述

Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation. Randomization is balanced by screening HIV viral load of less than 30,000 copies/ml or at least 30,000 copies/ml and by site. Patients also receive open-label efavirenz (EFV) and lamivudine (3TC). Efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period (56 weeks).

研究设计

研究类型
Interventional
主要目的
Treatment
盲法
Double

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry

研究点 (108)

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