NCT00405249已完成2 期
14-Day Randomized Double-Blind Comparative Viral Kinetic Study of Elvucitabine Versus Lamivudine Once Daily to HIv-1 Subjects With M184V
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
研究概览
简要总结
The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.
详细描述
This is a 14 day on treat/14 day off treatment randomized, double blind viral kinetic study of elvucitabine versus lamivudine administered once daily to HIV infected subjects with a documented M184V variant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infected, clinically stable, adults
- •HIVRNA 5000 -150,000, CD4 100
- •Genotypically documented M184V variant
- •Receiving stable ART.
排除标准
- •HIV-1 genotype for 4 protease inhibitors
- •HIV-1 genotype positive for 2 NNRTI mutations
- •Previous therapy with system myelosuppressive potential within 3 months of study start
- •Use of Epogen or Neupogen
- •History of cirrhosis
- •Alcohol or drug dependence
- •Inability to tolerate oral medication
- •Women who are pregnant or breast feeding
研究者
研究点 (2)
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