Durability of Antiretroviral Suppression and the Real World Clinical Profile of the Novel 2-Drug Regimen Juluca, a Onepill-Regimen Consisting of Dolutegravir and Rilpivirine, in Routine Clinical Care in Germany
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Number of Participants With Sustained Virologic Suppression at Year 3
研究概览
简要总结
This was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on JULUCA use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care in HIV positive participants in Germany. Approximately 250 virologically suppressed HIV positive participants on stable antiretroviral therapy (ART) were included in the study at the discretion of treating physician. Eligible participants were followed up for approximately 3 years and data was collected during routine clinical care.
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
- •Greated than or equal to (>=)18 years of age.
- •Documented HIV-1 infection.
- •Virologically suppressed (HIV-1 ribonucleic acid [RNA] less than [<] 50 copies [c]/mL for at least 6 months)
- •Prescription for JULUCA was issued independently from entering this study.
- •Ability to understand informed consent form and other relevant study documents
排除标准
- •Any contraindication according to JULUCA SmPC.
- •Documented viral load greater than (>) 50 c/mL at any time point within 6 months prior to inclusion into this study.
- •History of treatment failure.
- •Known or suspected substitutions associated with resistance to any non-nucleoside reverse-transcriptase inhibitors (NNRTI) or integrase strand transfer inhibitor (INSTI).
- •Any ART for the treatment of HIV-1 in addition to JULUCA.
- •Hepatitis B virus (HBV)-co-infection.
- •Current participation in the ongoing non-interventional study TRIUMPH (study number: 202033) or any interventional clinical trial irrespective of indication.
- •Previous participation in clinical trials involving JULUCA.
研究组 & 干预措施
Participants who received JULUCA
Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir [DTG] / Rilpivirine [RPV]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.
干预措施: JULUCA (Drug)
结局指标
主要结局
Number of Participants With Sustained Virologic Suppression at Year 3
时间窗: At Year 3
Virologic suppression (VS) was defined as HIV-RNA less than (\<) 50 copies (c)/mL for at least 6 months or, if between 50-200 c/mL with a subsequent next available measurement (within 120 days) \<50 c/mL at Year 3 follow-up. Any subsequent measurement was accepted as a consecutive measurement as long as measured no later than 120 days after the initial measurement. If no subsequent HIV-RNA measurement was performed within 120 days, this was scored as a confirmed HIV-RNA greater than or equal to (\>=)200 c/mL.
次要结局
- Number of Participants With Sustained Virologic Suppression at Year 1 and Year 2(At Year 1 and Year 2)
- Number of Participants With Low Level Viremia(At Year 1, Year 2 and Year 3)
- Number of Participants With Virologic Rebound(At Year 1, Year 2 and Year 3)
- Number of Participants With Treatment Switch(At Year 1, Year 2 and Year 3)
- Number of Monitoring Measures During the 3-year Follow-up(Up to Year 3)
- Number of Participants With Serious Adverse Events (SAEs)(Up to Year 3)
- Number of Participants With Adverse Drug Reactions (ADRs)(Up to Year 3)
- Number of Participants With Adherence to Therapy(At Year 1, Year 2 and Year 3)
- Change From Baseline (BL) in Lipid Laboratory Values(At Year 1, Year 2 and Year 3)
- Change in Treatment Satisfaction(At Year 1, Year 2 and Year 3)
- Change in Symptom Distress(At Year 1, Year 2 and Year 3)
- Number of Participants by Reasons for Therapy Switch to JULUCA(At Baseline (Day 1))