NCT04041362撤回2 期
A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients
United BioPharma0 个研究点开始时间: 2020年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- treatment related TEAEs
研究概览
简要总结
This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.
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
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 seropositive
- •Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- •have been receiving antiretroviral therapy (ART) for more than 2 years
排除标准
- •Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment.
- •Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and/or physical examination that, in Investigator's opinion, would preclude the subject from participating in this study.
- •History of anaphylaxis to monoclonal antibodies.
- •Any vaccination within 8 weeks prior to the first dose of UB-421.
结局指标
主要结局
treatment related TEAEs
时间窗: 16 Weeks
the incidence of Grade 3 drug-related treatment-emergent adverse events
次要结局
未报告次要终点
研究者
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