Imaging the HIV Reservoir
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Comparisons of PET standard uptake values in regions of interest (gastrointestinal tract, lymph node groups, genital tract, and spleen) between the three groups (uninfected, viremic and aviremic infected)
研究概览
简要总结
Radiolabelling broadly neutralizing anti-HIV antibody 3BNC117 with a Copper-64 radio isotope for infusion into people with HIV followed by MRI/PET scanning to detect HIV in vivo.
详细描述
This study aims to develop a method to accurately image the size and location of HIV persistence in HIV-infected individuals. The project aims to combine the broadly neutralizing anti-HIV antibody 3BNC117 with a Copper-64 radio isotope for use in a clinical trial.
The clinical trial has three different stages. The first stage is to recruit two HIV uninfected individuals and determine the safety of 3 mg/kg of 3BNC117 combined with Copper-64 and MRI/PET scanning at 1, 24 and 48 hours post infusion. The second stage is to examine the distribution on MRI/PET of the 3BNC117-Copper-64 combination in four HIV-infected individuals with viremia who are not receiving antiretroviral therapy. The final stage is to perform the same intervention in aviremic people with HIV receiving antiretroviral therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HIV uninfected
A single intravenous infusion of 3mg/kg 3BNC117 combined with Copper-64 to 2 HIV uninfected individuals
干预措施: 3BNC117-Copper-64 (Drug)
HIV infected viremic
A single intravenous infusion of 3mg/kg 3BNC117 combined with Copper-64 to 4 HIV infected individuals with viremia who are not receiving antiretroviral therapy
干预措施: 3BNC117-Copper-64 (Drug)
HIV infected aviremic
A single intravenous infusion of 3mg/kg 3BNC117 combined with Copper-64 to 4 HIV infected individuals with undetectable HIV viral load who are receiving antiretroviral therapy
干预措施: 3BNC117-Copper-64 (Drug)
结局指标
主要结局
Comparisons of PET standard uptake values in regions of interest (gastrointestinal tract, lymph node groups, genital tract, and spleen) between the three groups (uninfected, viremic and aviremic infected)
时间窗: 2 days
To determine if there is increased PET uptake in HIV viremic and aviremic groups as compared to uninfected group
次要结局
- Comparisons of PET standard uptake values in regions of interest within each individual to radioactivity levels in a homogenous area of muscle to generate target to muscle ratios.(2 days)
- Safety and tolerability (adverse events and assessment of laboratory parameters)(2 weeks)