Multicenter Retrospective Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 762
- 试验地点
- 20
- 主要终点
- Virological effectiveness data: Percentage of patients with undetectable viral load
研究概览
简要总结
This is a retrospective observational study of patients who have taken a regimen containing DRV / c at least 24 weeks prior to study initiation
详细描述
The study will include 750 patients and will record data at 24 weeks. The study will also record data at 48 weeks for those patients whom these data are available
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients with HIV infection
- •Inform consent document.
- •To have initiated therapy containing DRV / c and have a follow-up of at least 24 Weeks.
排除标准
- •Not having evaluable clinical data of the patient
- •Patients not routinely followed in the center
- •Patient less than 18 years of age.
结局指标
主要结局
Virological effectiveness data: Percentage of patients with undetectable viral load
时间窗: 24 weeks
Virological effectiveness data at 24 weeks: Percentage of patients with undetectable viral load, defined as HIV RNA \<50 copies / m.
Virological effectiveness data: time to loss of virological efficacy.
时间窗: 24 weeks
Defined virological failure as two consecutive levels of HIV RNA \> 50 copies / mL or single HIV RNA ≥ 500 copies / mL
Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks
时间窗: 24 weeks
Change in the number of CD4 + T cells at 24 weeks
次要结局
- Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI).(Basal and 24 weeks/48 weeks)
- Tolerability data:Rate of patients discontinuing treatment for toxicity.(24 weeks/48 weeks)
- Virological effectiveness data: Percentage of patients with undetectable viral load, defined as HIV RNA levels ≤ 50 copies / mL or limit of detection of the center, at 48 weeks(48 weeks)
- Reason for the change prior the initiation:Percentage of patients with each main reason to change to a DRV/c based regimen (first regimen, simplification, intolerance or toxicity, prior adherence problems, prior interactions, prior failure, others)(24 weeks / 48 weeks)
- Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks(48 weeks)
- Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG.(basal and 24 weeks/48 weeks)
- Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT(basal and 24 weeks/48 weeks)
- Rate of patients who develop any adverse effects:frequency of adverse events,frequency of serious adverse events, frequency of adverse events leading to discontinuation of treatment, number of deaths and frequency of laboratory abnormalities.(24 weeks/48 weeks)
- Representative subgroups of patients according to the treatment that patient is taking: Percentage of patients with different Darunavir/cobicistat based regimens (Monotherapy, Bitherapy, triple Therapy, others)(24 weeks / 48 weeks)
- Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen(24 weeks / 48 weeks)
- Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks(24 weeks/48 weeks)