Characterization of the Residual Replication of HIV-1 in the Gut-associated Lymphoid Tissue in Patients Receiving Effective Highly Active Antiretroviral Therapy: the ANRS EP 44 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT.
研究概览
简要总结
HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication. This project aims to characterize the residual replication of HIV-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid tissue.
详细描述
Highly active antiretroviral therapy (HAART) successfully controls HIV-1 replication in most individuals, resulting in substantial immune restoration and decreased morbidity and mortality. However HIV-1 cannot be eradicated from infected individuals by current regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication, despite maximum virus suppression on HAART. This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT). A group of 20 HIV-1-infected patients on effective HAART will undergo GI endoscopy and GALT biopsies will be taken. A sample of venous blood will also be collected. These samples will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT. HIV-1 coreceptor usage and its evolution on HAART will be characterized in virus reservoirs. This project could provide further insights into the residual replication of HIV-1 in subjects receiving HAART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV-1 infection (ELISA and western-blot tests)
- •Continuous antiretroviral therapy >= 12 months
- •Plasma HIV-1 RNA =< 40 copies/ml >= 6 months
- •Indication of gastro-intestinal endoscopy
- •Age >= 18-year old
- •Physical examination
- •Informed consent
排除标准
- •Plasma HIV-1 RNA > 40 copies/ml in the last 6 months
- •Involvement in a HIV vaccine study
- •Treatment with interferon-alpha or PEG- interferon-alpha in the last 6 months
- •Treatment with interleukin-2 in the last 6 months
- •Decompensated cirrhosis
- •Abnormal hemostasis tests
- •Inflammatory bowel disease ; coeliac disease
- •Blood transfusion in the last 6 months
- •Absence of social security (health insurance)
- •Pregnant or breastfeeding woman
- •Incapable adult
结局指标
主要结局
Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT.
次要结局
- HIV-1 DNA load in the GALT vs blood CD4+ T cells
- HIV-1 tropism in the GALT vs blood CD4+ T cells
- Characterization of residual HIV-1 in the plasma < 40 copies/ml
- Characterization of HIV-1 DNA in blood monocytes
