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Evaluation Study of Clinical Efficacy of Incomplete Immune Reconstitution after ART for AIDS Based on Evidence-based Treatment

注册号：

Registration number：

ITMCTR2025001016

最近更新日期：

Date of Last Refreshed on：

2025-05-21

注册时间：

Date of Registration：

2025-05-21

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于辨证论治艾滋病ART后免疫重建不良的临床疗效评价研究

Public title：

Evaluation Study of Clinical Efficacy of Incomplete Immune Reconstitution after ART for AIDS Based on Evidence-based Treatment

注册题目简写：

基于辨证论治艾滋病ART后免疫重建不良的临床疗效评价研究

English Acronym：

Evaluation Study of Clinical Efficacy of Incomplete Immune Reconstitution after ART for AIDS Based on Evidence-based Treatment

研究课题的正式科学名称：

基于辨证论治艾滋病ART后免疫重建不良的临床疗效评价研究

Scientific title：

Evaluation Study of Clinical Efficacy of Incomplete Immune Reconstitution after ART for AIDS Based on Evidence-based Treatment

研究课题的正式科学名称简写：

基于辨证论治艾滋病ART后免疫重建不良的临床疗效评价研究

Scientific title acronym：

Evaluation Study of Clinical Efficacy of Incomplete Immune Reconstitution after ART for AIDS Based on Evidence-based Treatment

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

李鑫

研究负责人：

李鑫

Applicant：

lixin

Study leader：

lixin

申请注册联系人电话：

Applicant telephone：

13910908996

研究负责人电话：

Study leader's telephone：

13910908996

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

leaxin@sina.com

研究负责人电子邮件：

Study leader's E-mail：

leaxin@sina.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

北京市朝阳区京顺东街8号

研究负责人通讯地址：

北京市朝阳区京顺东街8号

Applicant address：

8 Jingshun East Street Chaoyang District Beijing

Study leader's address：

8 Jingshun East Street Chaoyang District Beijing

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

首都医科大学附属地坛医院

Applicant's institution：

Beijing Ditan Hospital Capital Medical University

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

KY2024-006-02,KY2024-006-04

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

首都医科大学附属地坛医院伦理委员会

Name of the ethic committee：

Ethics Committee of Beijipg Ditan HospitalCapital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024/2/2 0:00:00

伦理委员会联系人：

张如意

Contact Name of the ethic committee：

ruyi zhang

伦理委员会联系地址：

北京市朝阳区京顺东街8号

Contact Address of the ethic committee：

8 Jingshun East Street Chaoyang District Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

010-84322127

伦理委员会联系人邮箱：

Contact email of the ethic committee：

bjdtyyll@163.com

研究实施负责（组长）单位：

首都医科大学附属地坛医院

Primary sponsor：

Beijing Ditan Hospital Capital Medical University

研究实施负责（组长）单位地址：

北京市朝阳区京顺东街8号

Primary sponsor's address：

8 Jingshun East Street Chaoyang District Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中华人民共和国

省(直辖市)：

北京市

市(区县)：

朝阳区

Country：

china

Province：

beijing

City：

单位(医院)：

首都医科大学附属地坛医院

具体地址：

北京市朝阳区京顺东街8号

Institution
hospital：

Beijing Ditan Hospital Capital Medical University

Address：

8 Jingshun East Street Chaoyang District Beijing

经费或物资来源：

省部级（北京市卫生健康委员会）

Source(s) of funding：

Beijing Municipal Health Commission

研究疾病：

艾滋病ART后免疫重建不良

研究疾病代码：

Target disease：

Incomplete Immune Reconstitution after ART for AIDS

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

1.1探讨基于唐草片治疗和参灵固本辨证治疗的疗效及安全性，是对中医药临床疗效研究的进一步深入和拓展，逐步形成以参灵固本和唐草片辩证治疗为核心的治疗艾滋病ART后免疫重建不良的中西医结合治疗优化方案，为该病治疗提供循证医学证据。 1.2在前期数据基础上，筛选艾滋病ART后免疫重建不良疗效评价指标，确定优选指标集，探索建立中西结合治疗艾滋病ART后免疫重建不良的疗效评价体系，多维度构建临床疗效评价策略，探索中药干预治疗的优势人群，为中医药精准治疗提供依据。

Objectives of Study：

1.1 To explore the efficacy and safety of treatment based on Tangcao tablets and Shenling Guyuan syndrome differentiation is to further deepen and expand the research on the clinical efficacy of traditional Chinese medicine and gradually form an optimized treatment plan of integrated Chinese and Western medicine for the treatment of poor immune reestablishment after AIDS ART with Shenling Guyuan and Tangcao tablets dialectical treatment as the core so as to provide evidence-based medical evidence for the treatment of this disease. 1.2 On the basis of the previous data the evaluation indicators of adverse immune reconstructive effect after AIDS ART were screened the optimal index set was determined the therapeutic effect evaluation system for the combination of Chinese and Western treatment of adverse immune reconstructive effect after AIDS ART was explored the clinical efficacy evaluation strategy was constructed in multiple aspects and the advantages of Chinese medicine intervention treatment were explored to provide basis for the accurate treatment of traditional Chinese medicine.

药物成份或治疗方案详述：

① 评价基于唐草片和参灵固本的辨证治疗艾滋病ART后免疫重建不良的中西医结合方案的疗效及安全性 - 纳入符合诊断标准的ART后免疫重建不良患者240例，随机分为西医治疗组（单纯ART+安慰剂）和中西医结合治疗组（ART+中药治疗），两组各120例。中西医结合治疗组根据虚实辨证，分为为ART+参灵固本治疗组（虚症为主）和ART+唐草片治疗组（实证或虚实夹杂为主），治疗12周后进行中医辨证，若证型以虚转实或虚实夹杂证，则改用ART+唐草片治疗12周，若证型以实或虚实夹杂转为虚证，则改用ART+参灵固本治疗12周，若证型无变化，则继续使用原方案治疗，所有患者共治疗24周，随访24周。分别收集患者基线、4周、12周、24周、48周临床资料及EDTA抗凝血，并检测患者的相关指标HIV病毒载量、T细胞亚群、血常规、尿常规、肝功能、肾功能、记录并发症及不良事件等，评价唐草片和参灵固本的疗效及安全性。 ② 探索构建中西结合治疗艾滋病ART后免疫重建不良的疗效评价体系 - 利用人工神经网络模型、粗糙集理论、遗传算法、决策树等多种机器学习方法对艾滋病相关生物学、病毒学、免疫学、评价量表等疗效评价指标进行分析，在前期工作基础上进行疗效指标筛选，选择适合的算法，确定优选指标集，构建艾滋病的疗效评价体系。

Description for medicine or protocol of treatment in detail：

① Evaluation of the Efficacy and Safety of an Integrated Chinese and Western Medicine Treatment for Poor Immunological Reconstruction after ART in AIDS Based on Tangcao Tablets and Shenling Guben A total of 240 patients meeting the diagnostic criteria for poor immunological reconstruction after ART were randomly divided into a Western medicine treatment group (ART + vehicle) and an integrated Chinese and Western medicine treatment group (ART + Chinese herbal medicine) with 120 patients in each group. Based on syndrome differentiation of deficiency and excess the integrated treatment group was further divided into an ART + Shenling Guben subgroup (primarily deficiency syndrome) and an ART + Tangcao Tablets subgroup (primarily excess syndrome or mixed deficiency and excess syndrome). After 12 weeks of treatment syndrome differentiation was conducted. If the syndrome type changed from deficiency to excess or mixed deficiency and excess patients were switched to ART + Tangcao Tablets for another 12 weeks. If the syndrome type changed from excess or mixed deficiency and excess to deficiency patients were switched to ART + Shenling Guben for 12 weeks. If there was no change in syndrome type patients continued with the original treatment plan. All patients received a total of 24 weeks of treatment and were followed up for 24 weeks. Clinical data and EDTA anticoagulated blood samples were collected at baseline 4 weeks 12 weeks 24 weeks and 48 weeks. Relevant indicators such as HIV viral load T-cell subsets blood routine urine routine liver function kidney function and complications and adverse events were recorded to evaluate the efficacy and safety of Tangcao Tablets and Shenling Guben. ② Exploring the Construction of an Efficacy Evaluation System for Integrated Chinese and Western Medicine Treatment of Poor Immunological Reconstruction after ART in AIDS Various machine learning methods such as artificial neural network models rough set theory genetic algorithms and decision trees were utilized to analyze efficacy evaluation indicators related to AIDS biology virology immunology and evaluation scales. Based on preliminary work efficacy indicators were screened suitable algorithms were selected and an optimal set of indicators was determined to construct an efficacy evaluation system for AIDS. This system aims to provide a comprehensive and objective assessment of the efficacy of integrated Chinese and Western medicine treatments for poor immunological reconstruction after ART in AIDS patients.

纳入标准：

1: 接受HARRT治疗时间≤5年，血浆HIV载量＜50copies/ml大于12个月 2: 年龄介于18-65岁，男女不限 3: HIV抗体阳性，经Western Blot确证试验证实 4: CD4+T淋巴细胞计数＜350 cells/ul，或与治疗基线相比增长＜20% 5: -中医辨证符合虚证、实证、虚实夹杂证 6: 自愿参加本研究，并签署知情同意书

Inclusion criteria

1: - Duration of HARRT treatment ≤5 years plasma HIV load < 50copies/ml > 12 months 2: Participants aged between 18 and 65 years both males and females are eligible 3: HIV-positive status confirmed by Western Blot assay 4: CD4+ T-lymphocyte count ＜350 cells/ul or an increase of ＜20% compared to the baseline count at the start of treatment 5: Compatible with deficiency syndrome excess syndrome or a combination of both according to Traditional Chinese Medicine (TCM) differential diagnosis. 6: Volunteers who are willing to participate in this study and have signed the informed consent form.

排除标准：

1: CD4+T淋巴细胞计数＞350 cells/ul，或与治疗基线相比增长＞20%； 2: 入组前严重的机会性感染未得到控制者 3: 入组前1月内或正在参加其他药物临床试验的患者 4: 入组前1个月内接受免疫调节剂治疗者 5: WBC＜2×109/L，N＜1.0×109/L，Hb＜90g/L，PLT＜75×109/L，肝、肾功能异常（肝功能异常指AST或ALT或T-BIL≥参考值上限2倍，肾功能异常指肌酐清除率低于正常值） 6: 妊娠或哺乳期妇女，或准备妊娠妇女 7: 合并其他严重的疾病（如肿瘤，肝硬化，心脑血管病等 8: 存在智力或语言障碍，不能充分理解试验内容或给予良好合作的患者

Exclusion criteria：

1: CD4+T lymphocyte count > 350 cells/ul or > 20% increase from treatment baseline 2: Patients with severe opportunistic infections that were not controlled before enrollment 3: Patients who participated in other drug clinical trials within one month before enrollment or are currently participating 4: Patients who received immunomodulator therapy within one month before enrollment 5: Patients with WBC < 2×109/L N < 1.0×109/L Hb < 90g/L PLT < 75×109/L abnormal liver or kidney function (abnormal liver function refers to AST or ALT or T-BIL ≥ 2 times the upper limit of the reference value and abnormal kidney function refers to creatinine clearance rate below normal) 6: Women who are pregnant or breastfeeding or women planning to become pregnant 7: Patients with other severe comorbidities (such as cancer liver cirrhosis cardiovascular and cerebrovascular diseases etc.) 8: Patients with intellectual or language disabilities who cannot fully understand the trial content or provide good cooperation

研究实施时间：

Study execute time：

从From 2024-01-01

至To      2026-12-31

征募观察对象时间：

Recruiting time：

从From 2024-02-05

至To      2026-12-31

干预措施：

Interventions：

组别：

西医组

样本量：

120

Group：

Western Medicine Group

Sample size：

干预措施：

西医治疗

干预措施代码：

2

Intervention：

western medicine treatment

Intervention code：

组别：

中医组

样本量：

120

Group：

Chinese Medicine Practitioners Board

Sample size：

干预措施：

中医治疗

干预措施代码：

1

Intervention：

traditional chinese medicine treatment

Intervention code：

样本总量 Total sample size ： 240

研究实施地点：

Countries of recruitment
and research settings：

国家：

中华人民共和国

省(直辖市)：

北京市

市(区县)：

东城区

Country：

china

Province：

beijing

City：

单位(医院)：

中国中医科学院

单位级别：

国家中医药管理局直属的集科研、医疗、教学为一体的综合性中医药研究机构

Institution/hospital：

China Academy of Chinese Medical Sciences

Level of the institution：

It is a comprehensive Chinese medicine research institution directly under the State Administration of Traditional Chinese Medicine, integrating scientific research, medical treatment and teaching

国家：

中华人民共和国

省(直辖市)：

北京市

市(区县)：

北京市朝阳区

Country：

china

Province：

Beijing

City：

单位(医院)：

首都医科大学附属地坛医院

单位级别：

三甲医院

Institution/hospital：

Beijing Ditan Hospital Capital Medical University

Level of the institution：

Tertiary hospital

国家：

中华人民共和国

省(直辖市)：

北京市

市(区县)：

丰台区

Country：

China

Province：

beijing

City：

单位(医院)：

首都医科大学附属佑安医院

单位级别：

三甲医院

Institution/hospital：

Beijing Youan Hospital Capital Medical University

Level of the institution：

Tertiary hospital

测量指标：

Outcomes：

指标中文名：

不良事件发生率：分别统计治疗4周、12周、24周、48周时不良事件发生率并分析

指标类型：

副作用指标

Outcome：

Adverse Event Rate: Respectively record and analyze the adverse event rate at 4 12 24 and 48 weeks of treatment

Type：

Adverse events

测量时间点：

基线、12周、24周、48周

测量方法：

Measure time point of outcome：

Baseline 12 weeks 24 weeks 48 weeks

Measure method：

指标中文名：

辅助性T细胞亚群

指标类型：

次要指标

Outcome：

helper T cell subsets

Type：

Secondary indicator

测量时间点：

基线、12周、24周、48周

测量方法：

Measure time point of outcome：

Baseline 12 weeks 24 weeks 48 weeks

Measure method：

指标中文名：

免疫重建有效率

指标类型：

主要指标

Outcome：

Immunological index

Type：

Primary indicator

测量时间点：

基线、4周、12周、24周、48周

测量方法：

Measure time point of outcome：

Baseline 4 weeks 12 weeks 24 weeks 48 weeks

Measure method：

指标中文名：

病毒载量：HIV–RNA或 HIV–DNA

指标类型：

次要指标

Outcome：

Viral Load: HIV-RNA or HIV-DNA

Type：

Secondary indicator

测量时间点：

基线、12周、24周、48周

测量方法：

Measure time point of outcome：

Baseline 12 weeks 24 weeks 48 weeks

Measure method：

指标中文名：

WHO生存质量量表

指标类型：

次要指标

Outcome：

World Health Organization Quality of Life Scale

Type：

Secondary indicator

测量时间点：

基线、12周、24周、48周

测量方法：

Measure time point of outcome：

Baseline 12 weeks 24 weeks 48 weeks

Measure method：

指标中文名：

安全性评价：生命体征、血常规、尿常规、肝肾功能等

指标类型：

副作用指标

Outcome：

Safety Evaluation: Vital Signs Blood Routine Test Urine Routine Test and Liver and Kidney Function etc.

Type：

Adverse events

测量时间点：

基线、12周、24周、48周

测量方法：

Measure time point of outcome：

Baseline 12 weeks 24 weeks 48 weeks

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

尿液

组织：

Sample Name：

urine

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

统计者用中央随机化

Randomization Procedure (please state who generates the random number sequence and by what method)：

Statisticians use central randomization

盲法：

双盲（对受试者和研究者均隐藏分组）

Blinding：

Double-blind (both participants and researchers are unaware of the group assignments)

是否共享原始数据：

IPD sharing：

是

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

中央随机系统网站 http://10.11.129.30:9080/#/login

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The central stochastic system web site http://10.11.129.30:9080/#/login

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

CRF EDC

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF EDC

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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