Switching From Atripla to Stribild Leads to Improvements in Central Nervous System Side Effects and Sleep Disturbances
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 主要终点
- Percentage of Patients With Viral Loads < 50 Following the Switch
研究概览
简要总结
Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.
详细描述
Stribild is a preferred regimen in the Department of Health and Human Services guidelines and has demonstrated non-inferiority to Atripla in treatment naïve patients out to 144 weeks (GS-102). Stribild also has statistically significant less Central Nervous System side effects, sleep disturbances and lipid elevations compared to Atripla. This study will evaluate the efficacy, safety, changes in Central Nervous System abnormalities and sleep disorders following a switch from virologically suppressed subjects on Atripla to Stribild.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV+ subjects 18 years of age or older
- •estimated Glomerular Filtration Rate > 70 mL/min
- •must currently be on Atripla and taking it for at least 3 months with a HIV-1 Viral Load < 50 copies/mL
- •no antiretrovirals prior to the initiation of Atripla
- •baseline genotyping
排除标准
- •pregnancy
- •unable to provide informed consent
- •enrolled in another study
研究组 & 干预措施
Stribild
Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
干预措施: Stribild (Drug)
结局指标
主要结局
Percentage of Patients With Viral Loads < 50 Following the Switch
时间窗: 24 weeks
percentage of patients with viral loads \< 50 following the switch at 24 weeks.
次要结局
- T-cell Changes(24 weeks)
- Improvements in Central Nervous System Toxicity Score(24 weeks)
- Improvements in Sleep Disorder Score(24 weeks)