Participation of Cytomegalovirus Infection or an Autoimmune Process in T Lymphocyte Activation of HIV-1 Infected Patients With Undetectable Viral Load on Antiretroviral Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Measurement of systemic lymphocyte activation
研究概览
简要总结
The purpose of this study is to assess the level of CD4 and CD8 T cell activation in an observational cohort study of HIV-1 patients, virosuppressed on combined antiretroviral therapy (< 50 copies/ml) for at least 2 years and to focus on two factors that could participate in this activation: cytomegalovirus infection and auto-immune disorders.
详细描述
T cell activation plays a central role in HIV pathogenesis and is highly correlated to disease progression even in HIV patients virosuppressed on combined antiretroviral therapy since years. The mechanisms underlying this activation in virosuppressed patients are poorly understood. Identifying some factors involved in immune activation that can be targeted by therapies could optimize the treatment of HIV patients. The purpose of this study is to assess the level of CD4 and CD8 T cell activation in an observational cohort study of HIV-1 patients, virosuppressed on combined antiretroviral therapy (< 50 copies/ml) for at least 2 years and to focus on two factors that could participate in this activation: cytomégalovirus infection and auto-immune disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 included in the Aquitaine ANRS CO3 cohort aged 18 years or older (confirmed HIV-1 infection and at least one follow-up in the cohort),
- •plasma HIV-1 RNA <50 copies / ml for at least 24 months under a highly active antiretroviral combination (treatment comprising at least 3 antiretroviral drugs) modified or initiated between 2005 and 2008,
- •Follow-up in one of the departments of Bordeaux University Hospital or Libourne Hospital,
- •Free, informed and written consent, signed by the patient and the investigator (Consent of the Aquitaine CO3 Cohort and linked to this specific study).
排除标准
- •Presence of 2 consecutive measurements of HIV RNA> 50 copies / ml,
- •History of immunotherapy treatments (interleukin-2),
- •Hepatitis B or C co-infections,
- •Pregnancy
- •Breastfeeding
- •Symptomatic infectious episode in progress.
研究组 & 干预措施
Single arm
Patient with confirmed HIV-1 infection
干预措施: Blood samples (Procedure)
结局指标
主要结局
Measurement of systemic lymphocyte activation
时间窗: At the screening
Measured by the expression of HLA-DR and CD38 markers on the surface of CD4 + and CD8 + LT by flow cytometry
次要结局
未报告次要终点