Generation of HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection Receiving HBV-active Antiretroviral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To characterize circulating and intra-hepatic anti-HBV T-cell responses longitudinally in HIV-1/HBV co-infected individuals, following effective anti-HBV therapy
研究概览
简要总结
The trial will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy treatment regimens.
详细描述
Longitudinal study of circulating and intra-hepatic HBV-specific T-cell immunity in the setting of a randomised, controlled, international, multi-centre outpatient trial. The trial will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy treatment regimens.
Study population: Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV viremia and are willing to start antiretroviral therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV positive
- •hepatitis-B co-infected
- •HBV/HIV therapy naive
- •>18 years of age
排除标准
- •Unable to sign consent form.
结局指标
主要结局
To characterize circulating and intra-hepatic anti-HBV T-cell responses longitudinally in HIV-1/HBV co-infected individuals, following effective anti-HBV therapy
时间窗: 48 weeks
次要结局
- To identify novel CD4 and CD8 T cell HBV epitopes associated with HBV clearance.(48 weeks)
- To identify emergence of cytotoxic T lymphocyte (CTL) "escape" mutants following anti-HBV therapy(48 weeks)
- To determine the effect of HIV-1 co-infection and anti-HBV T-cell responses on clearance of free virions and HBV reservoirs using viral dynamic parameters and direct quantification of HBV hepatic reservoirs(48 weeks)