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临床试验/NCT00053638
NCT00053638已完成3 期

A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.

GlaxoSmithKline59 个研究点 分布在 1 个国家目标入组 345 人开始时间: 2003年2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
入组人数
345
试验地点
59
主要终点
Viral load response at 48 weeks

研究概览

简要总结

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the 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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Viral load response at 48 weeks

时间窗: 48 weeks

次要结局

  • Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics(48 weeks)

研究者

申办方类型
Industry

研究点 (59)

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