Ex Vivo Study of Immune-Reconstitution Kinetics in HIV-infected ARV-naive Subjects, With Advanced Disease, Starting a Darunavir/Ritonavir or Efavirenz Based HAART (IMMUNO Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells
研究概览
简要总结
The purpose of this study is to study the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (HIV) infection starting a Darunavir/Ritonavir- or Efavirenz-based highly active antiretroviral therapy (HAART) regimen.
详细描述
This is an ex-vivo study (study which takes place outside the organism and records immune parameters from stored blood and cells of a defined population without any intervention by the researcher) to evaluate the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (HIV) infection starting a Darunavir/Ritonavir (DRV/r)- or Efavirenz (EFV)-based highly active antiretroviral therapy (HAART) regimen. In previously stored plasma blood samples, the role of DRV/r compared with EFV in reducing T-lymphocyte activation, DRV/r compared with EFV in recovering T-lymphocyte immune phenotype in peripheral blood and thymic production, and DRV/r compared with EFV in recovering T-lymphocyte function (functional immunity) will be studied. Blood samples will be analyzed before (baseline) and up to 48 weeks after initiating HAART.
Each patient will receive orally administered (given by mouth) regimens of either Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina or Efavirenz (EFV) + Tenofovir/Emtricitabina.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented human immunodeficiency (HIV)-1 infection
- •At baseline plasma blood sampling, has never received antiretroviral therapy
- •Attending the Clinic of Infectious Diseases of the University of Milan at San Paolo Hospital
- •Asymptomatic (demonstrating no acquired immunodeficiency syndrome [AIDS]-defining symptoms) at Baseline, Week 12, and Week 24
- •CD4 cell count >50 to <250/mm3 at Baseline
- •Receiving treatment with either Darunavir/Ritonavir + Tenofovir/Emtricitabina or Efavirenz + Tenofovir/Emtricitabina highly active antiretroviral therapy (HAART) regimens at Week 12, Week 24, and Week 48 plasma blood sampling.
- •Exclusion Criteria is not defined in protocol.
排除标准
- 未提供
研究组 & 干预措施
Darunavir/Ritonavir (DRV/r)
干预措施: Darunavir/Ritonavir (DRV/r) (Drug)
Efavirenz (EFV)
干预措施: Efavirenz (EFV) (Drug)
结局指标
主要结局
Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells
时间窗: Baseline and Week 24
次要结局
- Change in peripheral T-lymphocyte immune phenotype(Baseline, Week 12, Week 24 and Week 48)
- Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells(Baseline, Week 12, and Week 48)
- Change in peripheral T-lymphocyte turnover(Baseline, Week 12, Week 24 and Week 48)