NCT04985890尚未招募2 期
A Proof of Concept Study to Evaluate the Safety and Efficacy of UB-421 in Combination With Chidamide for Reduction of HIV Reservoir as Compared to UB-421 Alone in ART Stabilized HIV-1 Patients Who Undergo ART Interruption
UBP Greater China (Shanghai) Co., Ltd0 个研究点目标入组 20 人开始时间: 2024年3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
- 20
- 主要终点
- HIV-1 Total DNA levels
研究概览
简要总结
- To assess the impact of UB-421 and chidamide in changing HIV-1 viral reservoir profile among HIV-1 suppressed patients who undergo short-term ART interruption.
- To evaluate the safety and tolerability of UB-421 combined with chidamide among HIV-1 suppressed patients who undergo short-term ART interruption.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible to be included in the study only if ALL of the following criteria apply:
- •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 18 years or older.
- •Have been receiving at least (≧) 2 nucleoside/ nucleotide reverse transcriptase inhibitors (NRTI) plus one non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI, either boosted or un-boosted), integrase strand transfer inhibitor (INSTI) or entry inhibitor (EI) for more than 1 years.
- •Have more than 2 different alternative options of optimized ART regimen.
- •HIV-1 plasma viral load (VL) level well suppressed below 50 RNA copies/mL for at least (≧) 12 months.
- •No breastfeeding or pregnancy for women.
- •Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (eg, barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectable, combinational oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test.
- •Subjects must sign the informed consent before undergoing any study procedures.
排除标准
- •Subjects meeting ANY of the following criteria will be excluded from the study:
- •Subjects with active systemic infections, except for HIV-1, that the investigator feels the infections may confound evaluation and treatment for HIV-
- •Any acquired AIDS-defining illness such as non-Hodgkin's lymphoma or Kaposi's sarcoma according to the U.S. Centers for Disease Control and Prevention Classification System for HIV-1 Infection within the past 12 months .
- •Any documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks .
- •Any exposure to a monoclonal antibody within the past 12 weeks.
- •Any significant diseases (other than HIV-1 infection) or clinically significant findings, that, in the Investigator's opinion, would preclude the subject from well participation or confound the assessment of study objectives.
- •Current receiving treatment regimen for Diabetes, hepatitis B, hepatitis C, or latent tuberculosis.
- •History of anaphylaxis to any monoclonal antibodies or HDAC inhibitor agents.
- •Received blood transfusion or hematopoietic growth factor treatment, any vaccine, or a compound with HDAC inhibitor activity (such as valproic acid) recently.
- •Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to V
- •More than one change of ART regimen because of the inability to achieve or maintain suppression of viral replication to an HIV-1 RNA level < 200 copies/mL within the past 12 months
- •Receipt of any other investigational study agent(s) within 90 days.
- •Experienced urticaria in recent 6 months or ongoing or unresolved skin problems with rash-like symptoms .
结局指标
主要结局
HIV-1 Total DNA levels
时间窗: Post-treatment weeks up to 48 weeks
The change in HIV-1 Total DNA from baseline after the study drug administration.
次要结局
- The number of adverse subjects(Post-treatment weeks up to 48 weeks)
- HIV-1 Total DNA levels(Post-treatment weeks up to 48 weeks)
- Viral suppression(Post-treatment weeks up to 48 weeks)
- Treatment related TEAE(through study completion, an average of 0.5 year)
研究者
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