Dataids Prospective Observational Cohort on Quality of Care of French HIV Infected Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30,000
- 试验地点
- 39
- 主要终点
- Proportion of HIV treated patients with HIV plasma viral load < 50 copies/mL
研究概览
简要总结
The objective of the Dataids cohort is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data on a large cohort of HIV infected patients seeking care in 15 HIV centers in France in order :
- to provide and develop a surveillance system to describe clinical practice and temporal changes in the clinical course of HIV and HIV-related co-infections and co-morbidities in France.
- to assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities
The specific objectives are as follows
- To continue surveillance of HIV infection in France to describe temporal changes
- To evaluate the efficacy of ART and factors associated with ART efficacy
- To monitor the uptake and outcome of HCV therapy
详细描述
The Dataids cohort is a prospective observational cohort of 30,000+ patients followed in 15+ HIV centers scattered throughout France. The Dataids cohort is an ongoing collaboration and patients have been enrolled into the study since 2010; the data are collected from the clinics as part of routine care. Included patients should be patients who had a scheduled visit in the outpatient clinic regardless of CD4 cell count, HIV viral load or ART status. For all HIV patients enrolled and under follow up, demographic data, immunological and virological data, serological evidence for infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis, laboratory, therapeutic and clinical data are collected annually.
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
- •HIV-1 infected patients regardless of CD4 cell count and antiretroviral therapy status
排除标准
- •Patients under 18 years of age
- •Patients without written informed consent
结局指标
主要结局
Proportion of HIV treated patients with HIV plasma viral load < 50 copies/mL
时间窗: From date of enrollment, through study completion, an average of 6 months
次要结局
- Proportion of HIV/HCV coinfected patients who start treatment with direct acting antivirals agents(From date of enrollment, through study completion, an average of 1 year)
- proportion of HIV/HCV patients with undetectable HCV viral load after treatment with direct acting antivirals agents(From date of enrollment, through study completion, an average of 1 year)
- Proportion of HIV patients according to their antiretroviral status : naive, on treatment, therapeutic stop(From date of enrollment, through study completion, an average of 1 year)
- Proportion of HIV patients with CD4 cells count above 500 /ml(From date of enrollment, through study completion, an average of 1 year)
- Incidence of aids events among patients enrolled in the cohort study(From date of enrollment, through study completion, an average of 1 year)
- Incidence of non aids events among patients enrolled in the cohort study(From date of enrollment, through study completion, an average of 1 year)
- Incidence of antiretroviral modification due to simplification or failure(From date of enrollment, through study completion, an average of 1 year)