Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to ARVs - EOLE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 94
- 试验地点
- 19
- 主要终点
- Genotype for resistance determination
研究概览
简要总结
The purpose of this study is to evaluate, in patients in at least the second protease inhibitor (PI) line, the virological failures under Kaletra® and their consequences on protease and reverse transcriptase genotypes
详细描述
The purpose of this study is to evaluate, in patients in at least the second PI line, the virological failures under Kaletra® and their consequences on protease and reverse transcriptase genotypes:
- Characterisation of the changes in the resistance genotype in protease and reverse transcriptase,
- Description of the nature and frequency of selected mutations under Kaletra®,
- Description of the predictive factors for mutations and of the impact they could have on other PIs used as maintenance treatment (analysis based on available algorithms).
EOLE is a prospective, multicentre observation study offered to French virology laboratories and involving clinical teams .
It is a transversal study with retrospective data collection for patients meeting the study criteria (virological failure under Kaletra® after at least first line PI treatment).
The study comprises two enrolment periods, separated by an interval of one year, over a period ranging from 2007 to 2011. During this period, virological failures under Kaletra® are identified. For each period, the virologists collect data only from the moment when virological failure under Kaletra® is identified.
研究设计
- 研究类型
- Observational
- 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
- •Patient aged under 18 years,
- •Pre-treated by at least one protease inhibitor (PI) line,
- •In therapeutic failure of the antiretroviral (ARV) maintenance treatment containing Kaletra®.
- •Therapeutic failure is defined by a viral load> 50 copies/ml after at least three months' treatment with an ARV combination containing Kaletra®, always provided that genotyping is possible .
排除标准
- •Patients having received less than three months of Kaletra®,
- •Patients for whom the genotype information before starting Kaletra® and at the time of the failure of Kaletra® was not available,
- •Patients receiving another protease inhibitor (PI) concomitantly with Kaletra®.
结局指标
主要结局
Genotype for resistance determination
时间窗: Over the duration of the enrollment for each wave, over a total period of 18 months
Description of the predictive factors for mutations and of the impact they could have on other protease inhibitors (PIs) used as maintenance treatment (analysis based on available algorithms).
时间窗: Over the duration of the enrollment for each wave, over a total period of 18 months
次要结局
未报告次要终点