The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- HIV persistence
研究概览
简要总结
HIV medicines have led to dramatic improvements in health. However, there remains a concern for potential drug toxicities, cost of drugs, and need for life-long treatment. In addition, research has found that health is not completely restored in HIV-infected patients, even if they have been taking effective HIV medicines for a long time. This may be due to direct drug-toxicity, continued replication of the virus, and/or inflammation of the body in response to the virus. Therefore, a more complete understanding of how HIV stays in the body is necessary.
Recent research has shown that one of the places that HIV can stay in the body is in lymphatic tissues such as lymph nodes (even in patients who have been taking HIV medicines for a long time). In addition, the amount of damage to the lymphatic tissues can predict how the immune system (CD4+ T cell count) will respond to therapy.
The investigators therefore propose a study in which lymph nodes from the groin area will be removed, with the goals of: 1) seeing how much HIV is in lymph nodes and 2) seeing how much damage has happened to the lymph node architecture.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to give informed consent
- •No contraindication to surgical procedures
- •Palpable inguinal adenopathy at study entry
- •For HIV seropositive subjects, meeting one of the following criteria: (1) on stable highly active antiretroviral therapy (HAART) with a recent undetectable viral load (< 50 copies/mL) ("HAART suppressed"), (2) antiretroviral untreated with an undetectable viral load (< 50 copies/mL) ("elite" controllers), or (3) antiretroviral untreated with a detectable viral load (> 1000 copies/mL) ("non-controllers")
排除标准
- •Known anemia (HIV+ males Hct<34; females Hct<32) or contraindication to donating blood
- •Blood coagulation disorder (including bleeding tendency or problems in past with blood clots)
- •Platelets < 50,000/mm3
- •PTT > 2x ULN
研究组 & 干预措施
HIV negative
干预措施: Lymph node biopsy (Procedure)
HIV positive
干预措施: Lymph node biopsy (Procedure)
结局指标
主要结局
HIV persistence
时间窗: 1 year
次要结局
未报告次要终点