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T细胞相关免疫重建的临床研究
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注册号:

Registration number:

ChiCTR-ICR-15005775 

最近更新日期:

Date of Last Refreshed on:

2015-02-28 

注册时间:

Date of Registration:

2014-06-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

T细胞相关免疫重建的临床研究 

Public title:

Clinical Research of T cell Associated Immune Reconstitution 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

HIV抗原特异性记忆性CD8+T细胞过继免疫治疗的安全性研究 

Scientific title:

Safety study of HIV specific memory CD8+T cells adoptive immunotherapy 

研究课题代号(代码):

Study subject ID:

2012ZX10001-004-001-002 

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:

李珍 

研究负责人:

张永宏 

Applicant:

Zhen Li 

Study leader:

Yonghong Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13552519949 

研究负责人电话:

Study leader's telephone:

+86 13810108505 

申请注册联系人传真 :

Applicant Fax:

+86 010-63294417 

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:

lizhen_pumc@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13810108505@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.bjyah.com/ 

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:

北京市丰台区右安门外大街西头条8号 

研究负责人通讯地址:

北京市丰台区右安门外大街西头条8号 

Applicant address:

8 Xitoutiao, Youanmenwai St., Feng Tai Dist., Beijing, China 

Study leader's address:

8 Xitoutiao, Youanmenwai St., Feng Tai Dist., Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100069 

研究负责人邮政编码:

Study leader's postcode:

100069 

申请人所在单位:

首都医科大学附属北京佑安医院 

Applicant's institution:

Beijing You'an Hospital, Capital Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

京佑科伦字[2014]36号 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

首都医科大学附属北京佑安医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing YouAn Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-12-16 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

首都医科大学附属北京佑安医院 

Primary sponsor:

Beijing You'an Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市丰台区右安门外大街西头条8号 

Primary sponsor's address:

8 Xitoutiao, Youanmenwai St., Feng Tai Dist., Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京佑安医院

具体地址:

北京市丰台区右安门外大街西头条8号

Institution
hospital:

Beijing You'an Hospital, Capital Medical University

Address:

8 Xitoutiao, Youanmenwai St., Feng Tai Dist., Beijing, China

国家:

中国

省(直辖市):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学

具体地址:

广州市新港西路135 号

Institution
hospital:

Sun Yat-sen University

Address:

135 Xingang West Street, Guangzhou

经费或物资来源:

国家“十二五”艾滋病和病毒性肝炎等重大传染病防治重大专项 

Source(s) of funding:

National SandT Major Project for Infectious Diseases Control 

研究疾病:

获得性免疫缺陷病 

Target disease:

Acquired Immunodeficiency Disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

评价HIV特异性CD8+T细胞过继免疫治疗HIV感染者的安全性,为艾滋病 “功能性治愈”提供可能的策略。 

Objectives of Study:

To evaluate the safety of HIV specific CD8+ T cells adoptive immunotherapy, and provide possible strategy for "AIDS functional cure". 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 年龄 18-60周岁; 2. HIV抗体阳性,WB确证实验阳性者或持有HIV感染者证 3. HLA基因分型为HLA-A2型; 4. 接受抗病毒治疗大于6个月者; 5. HIV病毒载量<50 copies/ml;CD4计数基本正常者(>350/ul); 6. 经全面体检(包括一般检查、血尿常规、血生化检查、胸部X线、B超及心电图等)无严重的肝、肾功能损害且其他指标在基本正常范围者; 7. 实验室检查满足以下条件:Hgb≥120g/L(男性),Hgb≥110 g/L(女性);中性粒细胞绝对值(ANC)≥2*10e9/L;血小板≥100*109/L;肌酐≤100umol/L;谷草转氨酶(AST)和谷丙转氨酶(ALT)≤2.5×ULN; 8. 受试者应充分了解试验目的、性质、方法以及可能发生的反应; 9. 自愿参加本研究并签署知情同意书。 

Inclusion criteria

1. Age, 18 to 60 years; 2. HIV antibody positive; 3. HLA-A2 positive; 4. On stable ART for more than 6 months; 5. Plasma HIV viral load less than 50 copies/ml; CD4+ T cell count more than 350/ul; 6. Comprehensive medical examination without severe liver, kidney damage; 7. Hgb more tha at least 120g/L (male), more than at lest 110 g/L(femal); Neutrophils absolute value (ANC) more than at least 2*10^9/L; Platelet more than at least 100*10^9/L; Creatinine less than at least 100umol/L; Aspertate aminotransferase (AST) and third transaminase (ALT) less than 2.5xULN; 8. Subjects should completely understand the purpose, properties, methods, and possible response of the study; 9. Willing to sign informed consent. 

排除标准:

1. HIV病毒载量>50 copies/ml; 2. 合并严重机会性感染或肿瘤者; 3. 转氨酶超过正常值上限3倍,肌酐超过正常值; 4. 现患有较严重慢性病、代谢性疾病(如糖尿病)、神经及精神疾病者; 5. 既往患胰腺炎者; 6. 妊娠期、哺乳期妇女和不能按要求进行避孕的育龄妇女; 7. 根据研究者判断,具有较低入组可能性(如体弱、依从性差等); 8. 过敏体质者; 9. 怀疑或确定有酒精、药物滥用病史; 10.近三个月内参加过其他药物试验(中药除外)者; 11. 对静脉注射不能接受者; 12. 研究者认为任何不适合进入试验的其他因素。 

Exclusion criteria:

1. Plasma HIV viral load more than 50copies/ml; 2. With severe opportunistic infection or tumor; 3. AST or ALT more than 3xULN, Creatinine more than normal; 4. With severe chronic diseases, metabolic diseases (such as diabetes), neurological and psychiatric diseases; 5. With pancreatitis; 6. Pregnant women or women that plan to get pregnant during the study period; 7. Lower possibility into groups (such as the weak, poor adherence); 8. Allergic constitution; 9. With alcohol or drug abuse history; 10. With any other drug trial (except traditional Chinese medicine) in 3 months; 11. Cannot recipients for intravenous injection; 12. Other factors that not fit into the test. 

研究实施时间:

Study execute time:

From2013-01-01To 2015-12-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

20

Group:

expeiment group

Sample size:

干预措施:

HIV特异性T细胞免疫治疗

干预措施代码:

Intervention:

HIV-specific T cells immunotherapy

Intervention code:

组别:

对照组

样本量:

20

Group:

control

Sample size:

干预措施:

未进行细胞免疫治疗

干预措施代码:

Intervention:

adoptive immunotherapy off

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京佑安医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing You'an Hospital, Capital Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

CD4细胞计数

指标类型:

主要指标 

Outcome:

CD4 cell counts

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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

分离外周血单个核细胞,体外培养后回输至患者体内

Fate of sample:

Destruction after use 

Note:

Peripheral blood mononuclear cells were isolated and transfuse to patients after cultured in vitro.

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

软件

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

computor software

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

首都医科大学附属北京佑安医院

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

Beijing You'an Hospital, Capital Medical University

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:

首都医科大学附属北京佑安医院

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

Beijing Youan Hospital, Capital Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-06-27
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