Italian Retrospective and Prospective Observation of Antiretroviral Treatment in Patients Taking DarunavIr/cobicistAt Plus eMtricitabine and Tenofovir AlafeNamide fumaraTE - DIAMANTE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 18
- 主要终点
- Percentage of Participants with Virological Response at Week 48
研究概览
简要总结
The purpose of this study is to describe the effectiveness of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF), measured as virological response at Week 48 as per Food and Drug Administration (FDA) snapshot algorithm through collection of daily practice data in the Italian setting.
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
- •Having a confirmed diagnosis of Human Immunodeficiency Virus-1 (HIV-1)
- •Must sign a participation agreement/Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
- •Taking Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) as per Summary of Product Characteristics (SmPCs) since at least one month before enrollment:
- •i) Experienced participants [Group 1 and 2]: a) started their antiretroviral (ARV) treatment not before 1/1/2015, b) having at least 1 year of ARV treatment history at study enrollment, c) Group 1, having always been treated with Darunavir (DRV) since the start of ARV treatment as naïve, d) Group 2, not having been treated with DRV before starting of D/C/F/TAF, ii.) Naive (any Viral Load (VL) participants (Group 3)
排除标准
- •Participants unable to read, to write, to understand and sign the ICF
- •Currently enrolled in an interventional study
- •Currently enrolled in an observational study sponsored or supported by Janssen
- •Chemotherapy scheduled during study observation
研究组 & 干预措施
Group 1
Participants will not receive any intervention as a part of this study. This group will include participants in treatment with Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF), who were always being treated with boosted-darunavir (DRV)-based regimen. The primary data source will be the medical records of each participant participating in this study.
干预措施: D/C/F/TAF Fixed-Dose Combination (FDC) (Drug)
Group 2
Participants will not receive any intervention as a part of this study. This group will include participants who started their antiretroviral (ARV) treatment with any combination excluding DRV before starting D/C/F/TAF treatments, who were always being treated with ARV treatment with any combination excluding DRV before starting D/C/F/TAF treatments. The primary data source will be the medical records of each participant participating in this study.
干预措施: D/C/F/TAF Fixed-Dose Combination (FDC) (Drug)
Group 3
Participants will not receive any intervention as a part of this study. This group will include participants started with D/C/F/TAF as naive. The primary data source will be the medical records of each participant participating in this study.
干预措施: D/C/F/TAF Fixed-Dose Combination (FDC) (Drug)
结局指标
主要结局
Percentage of Participants with Virological Response at Week 48
时间窗: At Week 48
Percentage of participants with virologic response defined as plasma Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load (VL) less than (\<) 50 copies per milliliter (cp/mL) measured according to Food and Drug Administration (FDA) snapshot algorithm will be reported.
次要结局
- Time to Virosuppression(At Baseline (Visit 1))
- Number of Participants with Detectability Below Level of Quantification <50 copies/mL(At Baseline (Visit 1))
- Participant's Previous Antiretroviral (ARV) Treatment History Determined Using the Web-Based Electronic Case Report Form (eCRF)(At Baseline (Visit 1))
- Cluster Differentiation 4 (CD4) Cells Nadir Count(At Baseline (Visit 1))
- CD4 Cell Count(At Baseline (Visit 1))
- Cluster Differentiation 4/ Cluster Differentiation 8 (CD4/CD8) Ratio(At Baseline (Visit 1))
- Percentage of Participants with VL<50cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Age(Up to Week 48)
- Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Gender at Birth(Up to Week 48)
- Percentage of Participants with VL < 50 cp/mL Measured by the FDA Snapshot Algorithm and Stratified by Original Group(Up to Week 48)
- Percentage of Participants Withdrawing From the Study for any Reason(Up to Week 48)
- Percentage of Participants who are Virologic Responders (VL<50 cp/mL) Measured by the Time to Loss of Virological Response (TLOVR) Algorithm(Up to Week 48)
- Percentage of Participants with Virological Failure in Virosuppressed Participants(Up to Week 48)
- Change from Baseline in Human Immunodeficiency Virus-Treatment Satisfaction Questionnaire Score (HIV-TSQs) at Week 48(Baseline and Week 48)
- Change from Baseline in Participants Reported Outcome Based on Narrative Plots at Week 48(Baseline and Week 48)