An Open Label Long Term Safety Extension Study of Apricitabine in Treatment-experienced HIV-1 Infected Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Time to virological failure (DHSS definition)
研究概览
简要总结
The study will examine how safe and effective apricitabine is when given long term (as ongoing treatment) to HIV patients who have already completed the AVX-201 trial
详细描述
An ongoing study (AVX-201) is examining the safety and efficacy of apricitabine compared to 3TC in HIV patients who are failing therapy containing 3TC and have the presence of the M184V mutation in reverse transcriptase. This extension study (AVX-201E) is available to patients who complete the AVX-201 protocol.
Patients will continue to receive apricitabine open label for a further 96 weeks (making a total of 144 weeks from starting AVX-201) in addition to an optimised background. Safety markers and efficacy markers will be followed.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed AVX-201 protocol, Plasma HIV RNA <5000 copies/ml, CD4 cells >50
排除标准
- •Pregnant or breastfeeding females, withdrawal from AVX-201
研究组 & 干预措施
ATC 800mg BID
800mg ATC BID
干预措施: apricitabine (Drug)
结局指标
主要结局
Time to virological failure (DHSS definition)
时间窗: week 144
incidence of AEs and laboratory abnormalities
时间窗: Week 144
time to withdrawal due to AEs
时间窗: Week 144
次要结局
- Change from baseline HIV RNA(weeks 72, 96, 120, and 144)
- Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml(at weeks 72, 96, 120, and 144)
- Change from baseline and change in ratio of CD4+ and CD8+ counts(at weeks 72, 96, 120, and 144)