NCT05598580招募中4 期
Functional Cure Strategy and Clinical Study of AIDS--Study on the Reduction of HIV Viral Reservoir by Immunomodulators (IMs)
First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年11月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Decreased inflammatory factors in HIV-infected patients
研究概览
简要总结
The goal of this clinical trial is to learn about the function of immunomodulators in reducing HIV reservoir. The main questions it aims to answer are:
- Are immunomodulators able to reduce HIV reservoirs?
- How do immunomodulators reduce HIV reservoirs? Participants will be randomly and equally divided into three groups, one control group and two trial groups. All three groups will continue to receive antiretroviral therapy. The two experimental groups will additionally be given different immunomodulators lenalidomide and adenosylmethionine, respectively. The effectiveness of immunomodulatory agents in reducing viral reservoirs will be explored by comparing relevant indicators in the three groups.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age ≥ 18 and ≤ 65 years.
- •HIV-1 infection, confirmed by any licensed rapid HIV test and then a licensed Western blot.
- •Virologic suppression defined as HIV-1 RNA level below the limit of quantification prior to study entry.
- •CD4+ T cell count > 200 cells/mm3 prior to study entry.
- •Ability and willingness of participant or legal representative to provide written informed consent and attend study visits as scheduled at a participating site. Willingness of participant to accept the side effects of drugs.
- •All participants of reproductive potential, who are participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable method of contraception from 4 weeks before the start of the study to 4 weeks after the end of the study.
排除标准
- •Breastfeeding or pregnancy, or planned pregnancy during the study.
- •Poor treatment adherence.
- •Use of immunomodulators or systemic cytotoxic chemotherapy ≤ 6 months prior to study entry.
- •Any current diagnosis or past history of a significant cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, neuropsychiatric, psychiatric, or other serious illness. The following laboratory values obtained prior to entry:
- •Absolute neutrophil count (ANC) ≤ 1000/mm3
- •Platelets ≤ 75,000/mm3
- •Known allergy/sensitivity or any hypersensitivity to components of study drug or their formulation.
- •Unwilling to provide written informed consent.
研究组 & 干预措施
Lenalidomide
Experimental
Lenalidomide capsules (25 mg) were administered orally on days 1-21 of a 28-day cycle for 24 weeks with continuous antiretroviral therapy. After that, participants will be monitored for another 24 weeks.
干预措施: Lenalidomide (Drug)
Adenosylmethionine
Experimental
Adenosylmethionine capsules (1000 mg, twice a day) were administered orally for 24 weeks with continuous antiretroviral therapy. After that, participants will be monitored for another 24 weeks.
干预措施: Adenosylmethionine (Drug)
结局指标
主要结局
Decreased inflammatory factors in HIV-infected patients
时间窗: 48 weeks
The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6.
HIV reservoirs
时间窗: 48 weeks
The size of the HIV reservoir in blood determined by HIV-DNA and CA-HIV-RNA.
次要结局
- Gut microbiome(48 weeks)
- Immune activation(48 weeks)
- T-cell subsets(48 weeks)
- Tolerability and safety outcomes(48 weeks)
研究者
研究点 (1)
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