NCT03754803已完成不适用
Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Sustained Virologic Suppression
研究概览
简要总结
This is a prospective, non-interventional, multi-center study, in participants with clinical indication of Human Immunodeficiency Virus (HIV)-1 infection. The aim of the study was to generate the real world evidence for the use of DTG+3TC in routine clinical care in Germany to supplement data obtained from controlled clinical trials. Treatment naïve and pre-treated HIV-1 positive participants were enrolled in the study. The observation period for the study was 3 years. Data was collected from routine clinical care via electronic data capture (EDC) system.
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
- •Participants >= 18 years of age.
- •Participants with documented HIV-1 infection.
- •Prescription of DTG + 3TC was issued independently from entering this study.
- •Participants with the ability to understand informed consent form and other relevant regulatory documents.
排除标准
- •Any contraindication according to Tivicay or Lamivudine summaries of product characteristics (SmPCs).
- •Participants with VL > 500 c/mL.
- •Any antiretroviral therapy for the treatment of HIV-1 in addition to DTG and 3TC or the DTG/3TC fixed dose combination (FDC).
- •Participants with hepatitis B virus (HBV)- coinfection.
- •Participants with current participation in the ongoing non-interventional study TRIUMPH (study number: 202033, NCT number: NCT02342769) or in any interventional clinical trial irrespective of indication.
- •Participants who had previously participated in clinical trials assessing DTG+ 3TC.
结局指标
主要结局
Percentage of Participants With Sustained Virologic Suppression
时间窗: At Year 3
Virologic suppression is defined as a viral load (VL) less than (\<) 50 copies (c)/mL or, if between 50-200 c/mL, with a subsequent next available measurement \<50 c/mL (within 120 days).
次要结局
- Frequency of Any Adverse Drug Reactions(From Baseline until Year 3)
- Discontinuation Rates Due to Adverse Drug Reactions(From Baseline until Year 3)
- Percentage of Participants With Low Level Viremia(At Month 6 and years 1, 2 and 3)
- Percentage of Participants With Missed Monthly Doses(At years 1, 2 and 3)
- Frequency of Serious Adverse Events(From Baseline until Year 3)
- Percentage of Participants With Reasons for DTG+3TC Therapy Initiation(At Baseline)
- Number of Serious and Non-serious Adverse Drug Reactions (ADRs)(From Baseline until Year 3)
- Change in Symptom Distress(At years 1, 2 and 3 compared to Baseline)
- Percentage of Participants Referred to Another Medical Specialist(From Baseline until Year 3)
- Percentage of Participants With Virologic Rebound(From Baseline until Year 3)
- Percentage of Participants With Treatment Switch Due to Virologic Reasons or Due to Intolerability(From Baseline until Year 3)
- Number of Serious Adverse Events (SAEs)(From Baseline until Year 3)
- Change in Lipid Laboratory Values(At years 1, 2 and 3 compared to Baseline)
- Number of HIV-RNA Monitoring Measures(From Baseline until Year 3)
- Percentage of Participants With VL > 50 c/mL With Emergent Resistance Mutations(From Baseline until Year 3)
- Percentage of Participants With Reasons for Therapy Switch to DTG+3TC(At Baseline)
- Change in Treatment Satisfaction(At years 1, 2 and 3 compared to Baseline)
研究者
研究点 (1)
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