NCT05056974已完成2 期
A Phase II Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs Among ART Stabilized HIV-1 Patients Who Undergo ART Interruption
United BioPharma1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年12月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- HIV cell-associated RNA levels
研究概览
简要总结
This is a phase II proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo ART interruption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 sero-positive, with documented HIV-1 infection by official, signed, written history
- •Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 20 years or older.
- •No breastfeeding or pregnancy for women.
- •Have been receiving ART for more than 3 years by screening visit 1 (SV1).
- •Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception
- •Subjects must sign the informed consent before undergoing any study procedures.
排除标准
- •Subjects with active systemic infections, except for HIV-1
- •Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug.
- •Current receiving treatment regimen for hepatitis B, hepatitis C or latent tuberculosis
- •Any alcohol or illicit drug use
- •Receipt of any other investigational study agent(s) within 90 days before SV
- •Currently on the treatment for diabetes.
研究组 & 干预措施
UB-421 + chidamide
Experimental
UB-421 + chidamide combination therapy
干预措施: UB-421 (Biological)
UB-421 + chidamide
Experimental
UB-421 + chidamide combination therapy
干预措施: chidamide (Drug)
结局指标
主要结局
HIV cell-associated RNA levels
时间窗: Post-treatment weeks up to 48 weeks
The change in HIV-1 Total DNA from baseline after study drug administration.
次要结局
- HIV-1 Total DNA levels(Post-treatment weeks up to 48 weeks)
研究者
研究点 (1)
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