Incidence And Risk Factors For Acquired Immune Deficiency Syndrome (AIDS) Defining And Non-AIDS Defining Malignancies, And Other AIDS Defining Illnesses In The EuroSIDA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,181
- 主要终点
- Malignancy
研究概览
简要总结
Human Immunodeficiency Virus (HIV) infected patients who meet the entry criteria for the maraviroc pivotal trials (Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients, MOTIVATE) will be identified from the EuroSIDA HIV cohort. The rates of specific clinical adverse events in this identified patient population will be compared with the rates of these events in the participants of the MOTIVATE trials.
详细描述
All patients in EuroSIDA cohort that meet the entry criteria of MOTIVATE trials are included without any sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged over 16 at baseline.
- •Viral Load (VL) > 5000 copies/ml at baseline (and measured in 6 months prior to baseline).
- •No changes in antiretroviral (ARV) regimens in the month period prior to baseline, or on no ARVs in the month prior to baseline.
- •> 3 months exposure (sequential or cumulative) to at least 3 of the following;
- •Any nucleoside or nucleotide reverse transcriptase inhibitor (NRTI)
- •Non-nucleoside reverse transcriptase inhibitor (NNNRTI)
- •Protease Inhibitor (PI )
- •Enfuvirtide
排除标准
- 未提供
结局指标
主要结局
Malignancy
时间窗: Median follow up of 3 years
Opportunistic infection
时间窗: Median follow up of 3 years
Myocardial infarction
时间窗: Median follow up of 3 years
All cause death
时间窗: Median follow up of 3 years
Liver related death
时间窗: Median follow up of 3 years
次要结局
未报告次要终点