Ambispective Cohort Study to Evaluate the Effectiveness, Safety and Tolerance of a Doravirine-based Antirretroviral Regimen as a Switching Strategy in Virologically Supressed HIV Infected Patients: Real-world Data
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of participants with an HIV-1 viral load ≤ 50 and ≤ 200* copies/ml using snapshot algorithm.
研究概览
简要总结
Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.
详细描述
Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.
All patients who were switched to a doravirine-based regimen from date of its availability in the center (September 2020) due to clinical considerations and have available records will be retrospectively included until date of study approval (expected on July 2021).
Minor resistances in a basal genotype to NNRTI or previous failure to NNRTI as nevirapine or efavirenz will be accepted if doravirine it is combined with a high genetic barrier drug with complete activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Older than 18 years HIV-1 infected subjects.
- •Switched to a doravirine-based ART regimen under clinician criteria.
排除标准
- •Doravirine major resistance mutations (accessory mutations are allowed).
- •Major mutations to any of the other drugs combined with doravirine.
- •Pregnancy, active tuberculosis or any condition that contraindicate the use of doravirine.
结局指标
主要结局
Percentage of participants with an HIV-1 viral load ≤ 50 and ≤ 200* copies/ml using snapshot algorithm.
时间窗: Up to 96 weeks.
FDA snapshot algorithm (ITT-exposed).
次要结局
- Rate of changes in renal biomarkers.(Up to 48 weeks.)
- Tolerability rate of study patients.(Up to 48 weeks.)
- Rate of changes in lipid parameters.(Up to 48 weeks)
- Death rates among trial patients.(Up to 48 weeks.)
- Rate of changes in hepatic parameters.(Up to 48 weeks.)