NCT04404049尚未招募2 期
The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients
UBP Greater China (Shanghai) Co., Ltd0 个研究点目标入组 39 人开始时间: 2023年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 主要终点
- treatment related TEAEs
研究概览
简要总结
This is a Phase II, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard ART in ART-treated HIV-1 subjects with stably suppressed HIV-1 plasma VL. The study will be conducted at multiple study centers, designated AIDS hospitals in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 sero-positive
- •Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- •HIV-1 plasma RNA level below 50 RNA copies/mL.
排除标准
- •Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-
- •Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
- •Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
- •History of anaphylaxis to other mAbs.
- •Any vaccination within 8 weeks prior to the first dose of assigned drug.
- •Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
- •Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
结局指标
主要结局
treatment related TEAEs
时间窗: 48Weeks
the incidence of Grade 3 drug-related treatment-emergent adverse events
次要结局
- the change of immune profiles(16Weeks)
研究者
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