NCT02878642Unknown不适用
Cohort Study to Assess Electronic-caps Defined Adherence Patterns - Virological Outcome Relationship Amongst HIV-1 Infected Subjects Receiving Dolutegravir-Based Antiretroviral Therapy)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Virologic Efficacy
研究概览
简要总结
The main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance).
While the investigators goal is not to compare molecules (study with one arm) in terms of forgiveness, the results of this cohort in terms of forgiveness could be compared to other cohorts available.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age over 18 years
- •Information letter signed
- •ART (antiretroviral therapy) with at least 3 active molecules
- •Patients starting treatment with dolutegravir (naïve to antiretroviral treatment, switch, virologic failure)
排除标准
- •pregnant woman
- •Patient does not have responsibility for the observance of treatment (disorder of judgment, guardianship, institutionalization)
- •Patient receiving aid incompatible with compliance with the use of electronic pillbox
结局指标
主要结局
Virologic Efficacy
时间窗: week 24
Are defined as secondary virological failure condition patients to S24 a viral load above 40 copies / ml on 2 consecutive samples.
Adherence to dolutegravir measured by the electronic pill boxes
时间窗: From baseline up to week 24
Calculating the total compliance
次要结局
- Patient Genotype resistance if failure(Week 16 and 24)
研究者
研究点 (1)
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