A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany (DOL-ART)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Frequency of therapeutic monitoring measures in HIV-infected patients
研究概览
简要总结
DOL-ART is a multi-center, prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. The primary study objective is a descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany.
The study is designed to enroll approximately 400 patients. There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of dolutegravir, due to death, withdrawal of consent, lost to follow-up).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Documented HIV infection
- •Age ≥ 18 years
- •Decision for the first initiation of dolutegravir as part of an ART by the attending physician irrespective of inclusion in this observational study
- •Prior to the start of this study, the patient must have been receiving a dolutegravir-containing ART for at least 4 weeks
排除标准
- •Discontinuation of dolutegravir as part of an ART prior to the start of the study documentation
- •Participation in a clinical trial during this study
- •Participation in a clinical trial or compassionate use program with dolutegravir being or having been part of the investigational medication
研究组 & 干预措施
Dolutegravir
Prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.
干预措施: Dolutegravir (Drug)
结局指标
主要结局
Frequency of therapeutic monitoring measures in HIV-infected patients
时间窗: up to 3 years
Descriptive characterization of the frequency of therapeutic monitoring measures in HIV-infected patients under dolutegravir-containing ART in routine daily practice in Germany.
次要结局
- Resistance profile(from start of dolutegravir up to 3 years)
- Efficacy(from start of dolutegravir up to 3 years)
- Type of the therapeutic monitoring measures(up to 3 years)
- Number of participants with Serious Adverse Events and drug-related adverse events as a measure of safety and tolerability(up to 3 years)
- Reasons for selecting dolutegravir-containing ART(Baseline)
- Reasons for discontinuing dolutegravir-containing ART(Up to 3 years after baseline)
- Patient satisfaction(Up to 3 years from baseline)