An Open-Label, 48-Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Participants Who Have Completed 14 Days of Treatment in Protocol ACH443-014A.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 7
- 主要终点
- To Assess The Safety Of 48 Weeks Of 10 mg/daily (QD) Of Elvucitabine In Combination With ART
研究概览
简要总结
To assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in combination with background antiretroviral therapy (ART) in participants who completed Study ACH443-014A and meet the inclusion and exclusion criteria.
详细描述
This study is an open-label extension study for participants who have completed 14 days of treatment in Study ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine treatment (10 mg) will begin on Day 1 (Day 15 following completion of Study ACH443-014A) for all consenting participants in combination with background ART as determined by the Principal Investigator. Participants will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to Week 48.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have completed 14 days of treatment in Study ACH443-014A and who, in the Investigator's judgment, remain candidates to receive elvucitabine together with background ART.
排除标准
- •Failure to meet inclusion criteria
结局指标
主要结局
To Assess The Safety Of 48 Weeks Of 10 mg/daily (QD) Of Elvucitabine In Combination With ART
时间窗: September 2008
次要结局
- To Describe The Anti-viral Activity Of Elvucitabine In Combination With ART As Measured By Plasma HIV-1 Ribonucleic Acid (RNA) Over 24 Weeks(September 2008)