Targeted Therapies for Immunological Non-Responders in People With HIV: A Multicenter Clinical Study
2026年7月10日 更新者：Fu-Sheng Wang、Beijing 302 Hospital
This study focuses on people with HIV who experience incomplete immune reconstitution despite suppressive antiretroviral therapy (ART), characterized by persistently low CD4⁺ T cell counts and residual inflammation.
The underlying cause is largely attributed to the persistent HIV latent reservoir.
Recent evidence indicates that rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) commonly used in ART, has an immunomodulatory function beyond its antiviral activity.
It activates the CARD8 inflammasome - an intracellular "kill switch" - triggering pyroptosis selectively in HIV-infected cells.
In this study, rilpivirine will be added to suppressive ART in patients with incomplete immune reconstitution.
The investigators hypothesize that this strategy will reduce the latent reservoir, restore CD4⁺ T cell counts and function, attenuate excessive immune activation, and ultimately improve long-term clinical outcomes.
研究概览
研究类型
介入性
注册 (估计的)
21
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ruonan Xu, MD
- 电话号码：+8618611314169
- 邮箱：xuruonan2004@aliyun.com
学习地点
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Beijing、中国、100039
- 招聘中
- 302 Hospital
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接触：
- Fu-Sheng Wang, MD
- 电话号码：01066933328
- 邮箱：fswang302@163.com
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Guangzhou、中国
- 招聘中
- Guangzhou Eighth People's Hospital
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接触：
- Xiaoping Tang
- 电话号码：020-83838688
- 邮箱：tangxp@gzhmu.edu.cn
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Guangzhou、中国
- 招聘中
- The third affiliated hospital of Sun Yat-Sen University
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接触：
- Ying Zhang
- 电话号码：020-85253333
- 邮箱：zhangyg5@mail.sysu.edu.cn
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Shenzhen、中国
- 招聘中
- Shenzhen Third People's Hospital
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接触：
- Haitao Zhang
- 电话号码：0755-61222333
- 邮箱：497465011@qq.com
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100039
- 招聘中
- The Fifth Medical Center of PLA General Hospital
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接触：
- Fu-Sheng Wang, MD
- 电话号码：01066933328
- 邮箱：fswang302@163.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients with incomplete immune reconstitution, aged between 18 and 65 years (inclusive).
- At enrollment, have received antiretroviral therapy (ART) for more than 4 years, with plasma HIV-RNA below the lower limit of detection (VL < 50 copies/mL) for more than 3 years, while CD4⁺ T cell count remains persistently below 350 cells/μL.
- Within 1 year prior to enrollment, CD4⁺ T cell count remains persistently below 350 cells/μL but above 200 cells/μL.
- Currently receiving a dolutegravir (DTG)-based ART regimen (e.g., DTG plus lamivudine, or the fixed-dose combination DTG/3TC/ABC) for ≥ 1 year, with no relevant drug resistance detected by high-precision resistance testing; no change in the core ART regimen within 1 year prior to enrollment (adjustments of auxiliary medications for side effect management are permitted); and agree to continue the current integrase inhibitor-based regimen for at least 1 year after enrollment.
- Willing and able to provide written informed consent prior to any study-related procedures, and to comply with all study requirements.
Exclusion Criteria:
- Co-infection with other viruses: positive for any of HBV, HCV, HDV, or HEV; or CMV/EBV viral load > 1000 copies/mL.
- HIV-2 infection alone or co-infection with HIV-1 and HIV-2.
- History of using efavirenz or rilpivirine within 2 years prior to enrollment.
- History of NNRTI resistance.
- Clinical signs suggestive of other serious diseases.
- Long-term use of corticosteroids or other immunosuppressive agents.
- Co-existing severe AIDS-related or non-AIDS-related events.
- Co-existing severe underlying diseases of other systems not related to AIDS.
- Other severe organic diseases or psychiatric disorders, including any uncontrolled clinically significant disease of the urinary, circulatory, respiratory, nervous, psychiatric, digestive, endocrine, immune systems, or malignancy.
- Receipt of immunosuppressive or systemic cytotoxic therapy within 6 months prior to screening.
- Evidence of substance abuse within 6 months prior to enrollment, or a positive urine drug screen.
- Current participation in another clinical trial that may conflict with the treatment protocol or outcome measures of this study.
- Pregnancy, breastfeeding, or women who have a desire to become pregnant.
- Inability or unwillingness to provide informed consent or comply with study requirements.
- Any other serious condition that may interfere with the conduct of the clinical trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：cART
Participants receive standard combination antiretroviral therapy (cART) alone (without rilpivirine).
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Participants receive standard combination antiretroviral therapy (cART) alone
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实验性的：cART plus Rilpivirine
Participants receive standard combination antiretroviral therapy (cART) plus rilpivirine
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Participants receive standard combination antiretroviral therapy (cART) plus rilpivirine
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
CD4⁺ T cell count
大体时间：Baseline to week 36
|
Baseline to week 36
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants with treatment-emergent adverse events
大体时间：From baseline to 36 weekks
|
Safety will be assessed by monitoring and recording all adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation.
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
From baseline to 36 weekks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月15日
初级完成 (估计的)
2028年12月30日
研究完成 (估计的)
2029年1月30日
研究注册日期
首次提交
2026年6月1日
首先提交符合 QC 标准的
2026年6月4日
首次发布 (实际的)
2026年6月10日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年7月10日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.