NCT02926456已完成不适用
Italian Observational, Multicenter Study in HIV1 -Positive, Virosuppressed Patients Currently in Treatment With Ritonavir-boosted Protease Inhibitors (PI/r) Starting Cobicistat-boosted Darunavir (DRV/c - Rezolsta®): the STart Of REzolsta (ST.O.RE.) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 337
- 主要终点
- Percentage of Patients With Human Immunodeficiency Virus - RiboNucleic Acid (HIV-RNA) Less Than (<)50 Copies/Milliliters (copies/mL) Measured at Week 48
研究概览
简要总结
The purpose of this study is to describe the effectiveness of darunavir/cobicistat (DRV/c)-based regimens, measured as maintenance of virological suppression 48 weeks after baseline, defined as the day when the treatment with DRV/c-based regimen is started, 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
- •Adult greater than or equal to (>=18 years), male and female patients
- •Documented Human Immunodeficiency Virus-1 (HIV-1) infection
- •Eligible to darunavir/cobicistat (DRV/c) treatment according to Summary of Product Characteristics
- •Patients who are able to understand the nature of the study and to provide their consent voluntarily having signed an Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements
- •Patients in stable (>= 12 months) treatment with an Antiretroviral (ARV) therapy PI/ritonavir (PI/r)-based, being prescribed Rezolsta (DRV/c) by treating physician
- •Patients virosuppressed (HIV-RNA less than [<] 50 copies/milliliters) since at least 6 months, within their HIV treatment at the moment of enrollment; single values of HIV-RNA more than [>] 50 copies/ml not confirmed (blips) will be considered acceptable; last value collected being < 50 copies/ml
排除标准
- •Patient currently enrolled in an interventional study
- •Patient currently enrolled in an observational study sponsored or supported by Janssen
- •Estimated Glomerular Filtration Rate (eGFR) < 70 milliliters per minute (ml/min) if any co-administered agent (example emtricitabine, lamivudine, tenofovir disoproxil fumarate, or adefovir dipivoxil) requires dose adjustment based on creatinine clearance
- •Pregnancy or breast feeding at enrollment
- •Allergy or intolerance to sulphonamides
- •Switch from darunavir/ritonavir (DRV/r) 600/100 bis in die (bid)
- •Patient currently in mono PI/r therapy
- •Patients to be treated within one year with Direct Acting Antivirals (DAAs) for Hepatitis C Virus (HCV) infection
- •Chemotherapy scheduled
结局指标
主要结局
Percentage of Patients With Human Immunodeficiency Virus - RiboNucleic Acid (HIV-RNA) Less Than (<)50 Copies/Milliliters (copies/mL) Measured at Week 48
时间窗: At Visit 4 (Week 48)
The percentage of patients with plasma HIV-RNA\<50 copies/mL will be analyzed by FDA snapshot analysis (FDA Snapshot Approach is based on the last observed viral load data within the Week 48 window: virologic response is defined as HIV-1 RNA \<50 copies/mL (observed case); If there are no data in the defined time window, the proportion of missing data and relative reason will be provided") and Time to loss of virologic response (TLOVR) method algorithm requires sustained HIV-1 RNA \< 50 copies/mL; confirmed HIV-1 RNA more than or equal to (\>=) 50 copies/mL is considered as non-response (rebound); patients considered non-responder after permanent discontinuation).
次要结局
- Change From Baseline in Low Density Lypoprotein (LDL)(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in Triglycerides(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in HIV-Symptoms Distress Module (HIV-SDM) Score(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in CD4 Percentage(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in High Density Lypoprotein (HDL)(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in Glucose(Baseline, Up to Visit 4 (Week 48))
- Percentage of Patients with HIV-RNA <50 copies/mL Measured at Week 24(At Visit 3 (Week 24))
- Change From Baseline in HIV-Treatment Satisfaction Questionnaire (HIV-TSQ) Score(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in Alanine-Amino Transferase (ALT)(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in CD4 Cell Count(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in CD4/CD8 Ratio(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in Creatinine Levels(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in estimated Glomerular Filtration Rate (eGFR)(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in Aspartate Transferase (AST)(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in Gamma-Glutamyl Transferase (GGT)(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in Alkaline Phosphatase (ALP)(Baseline, Up to Visit 4 (Week 48))
- Change From Baseline in Total Cholesterol(Baseline, Up to Visit 4 (Week 48))
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