今天是:2019-05-24 星期五

艾滋病功能性治愈策略和临床研究—潜伏感染反转剂(LRAs)序贯免疫调节剂(IMs)对HIV病毒储存库激活和清除作用的研究
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注册号:

Registration number:

ChiCTR1900023184 

最近更新日期:

Date of Last Refreshed on:

2019-05-15 

注册时间:

Date of Registration:

2019-05-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

艾滋病功能性治愈策略和临床研究—潜伏感染反转剂(LRAs)序贯免疫调节剂(IMs)对HIV病毒储存库激活和清除作用的研究 

Public title:

Functional cure strategy and clinical study of AIDS Study on the Activation and Removal of HIV Viral Reservoir by Immunomodulators 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

艾滋病功能性治愈策略和临床研究—潜伏感染反转剂(LRAs)序贯免疫调节剂(IMs)对HIV病毒储存库激活和清除作用的研究 

Scientific title:

Functional cure strategy and clinical study of AIDS Study on the Activation and Removal of HIV Viral Reservoir by Immunomodulators 

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:

朱彪 

研究负责人:

朱彪 

Applicant:

Biao Zhu 

Study leader:

Biao Zhu 

申请注册联系人电话:

Applicant telephone:

+86 13906535457 

研究负责人电话:

Study leader's telephone:

+86 13906535457 

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:

zhubiao1207@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhubiao1207@zju.edu.cn 

申请单位网址(自愿提供):

Applicant 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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310006 

研究负责人邮政编码:

Study leader's postcode:

310006 

申请人所在单位:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital, College of Medicine, Zhejiang 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:

2019672 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

浙江大学医学院附属第一医院 科研伦理审查委员会 

Name of the ethic committee:

Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-13 

伦理委员会联系人:

宋明红 

Contact Name of the ethic committee:

Minghong Song 

伦理委员会联系地址:

浙江省杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou, Zhejiang, China 

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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital, College of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

浙江省杭州市庆春路79号

Institution
hospital:

The First Affiliated Hospital, College of Medicine, Zhejiang University

Address:

79 Qingchun Road, Hangzhou, Zhejiang, China

经费或物资来源:

国家重大传染病研究计划 

Source(s) of funding:

National Special Research Program for Important Infectious Diseases 

研究疾病:

艾滋病 

Target disease:

AIDS 

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:

探索性研究/预试验 

Study phase:

研究目的:

针对艾滋病合并隐球菌脑膜炎治疗效果不佳的患者和艾滋病合并淋巴瘤患者在 联合方案(HAART治疗的基础上进行免疫治疗),包括来那度胺和PD-1等免疫调节剂(IMs),观察治疗后艾滋病合并隐球菌脑膜炎患者脑脊液、颅内病变和认知功能的好转;艾滋病合并肿瘤患者肿瘤的好转和生存期延长;变动态检测CD4+ T细胞计数、血浆病毒载量、HIV-1特异性CTL反应T细胞活化程度、HIV储存库分布和大小等相关指标,探索联合治疗方案对激活和清除病毒储存库的有效性;评估联合治疗方案的安全性和可行性;初步阐明多种免疫调节剂联合治疗方案对HIV病毒储存库激活和清除作用规律和机制。为进一步减少HIV传播和艾滋病功能性治愈提供理论依据和技术支撑。 

Objectives of Study:

Immunotherapy based on HAART therapy for patients with AIDS complicated with Cryptococcus meningitis and patients with AIDS complicated with lymphoma, including (IMs), such as lenalidomide and PD-1, is not effective in the treatment of AIDS complicated with Cryptococcus meningitis. To observe the improvement of cerebrospinal fluid (cerebrospinal fluid), intracranial lesions and cognitive function in patients with AIDS complicated with Cryptococcus meningitis after treatment. The improvement of tumor and the prolongation of survival time in patients with AIDS complicated with tumor. Variable dynamic detection of CD4 T cell count, plasma viral load, HIV-1 specific CTL reaction T cell activation degree, HIV repository distribution and size and other related indicators, to explore the effectiveness of combined therapy to activate and clear the virus repository. To evaluate the safety and feasibility of combined therapy, and to elucidate the law and mechanism of activation and clearance of HIV virus repository by multiple immunomodulator regimens. It provides theoretical basis and technical support for further reducing the spread of HIV and functional cure of AIDS. 

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:

队列一:艾滋病合并隐球菌脑膜炎治疗效果不佳的患者免疫调节治疗 (1)年龄18-65岁住院患者 (2)经初筛实验和WB确诊实验确认为HIV感染。病毒载量检测小于最低检测值。 (3)确诊为隐球菌脑膜炎患者:脑脊液隐球菌荚膜抗原阳性或脑脊液培养、涂片找到隐球菌,有脑脊液改变和MR显示颅内有病变者; (4)艾滋病合并肿瘤患者,已无法进行常规手术治疗或常规化疗无法缓解肿瘤的患者; (5)自愿签署患者知情同意书,并能保证接受定期随访和标本采集和相关治疗不良反应; 在研究开始前4周至研究结束4周均进行避孕措施。 队列二:艾滋病合并肿瘤患者使用PD-1单抗对艾滋病潜伏感染的影响。 (1)年龄18-65岁的住院患者 (2)经初筛实验和WB确诊实验确认为HIV感染。 (3)确诊肿瘤患者,有PD-1单抗使用指针,且有意愿使用的患者; (4)自愿签署患者知情同意书,并能保证接受定期随访和标本采集和相关治疗不良反应; 

Inclusion criteria

Cohort 1: immunomodulatory therapy was performed in patients with AIDS complicated with Cryptococcus meningitis (1) inpatients aged 18 to 65 years old; (2) HIV infection was confirmed by primary screening test and WB diagnosis test. Virus load detection is less than the minimum detection value; (3) patients with Cryptococcus meningitis were diagnosed as Cryptococcus meningitis: Cryptococcus in cerebrospinal fluid (cerebrospinal fluid) was positive or cultured in cerebrospinal fluid (cerebrospinal fluid), Cryptococcus vulgaris was found on smear, cerebrospinal fluid (cerebrospinal fluid) changes and MR showed intracranial lesions; (4) patients with AIDS complicated with tumor can no longer carry out routine surgical treatment or conventional chemotherapy can not alleviate the tumor; (5) voluntarily sign the informed consent form of the patient and ensure regular follow-up, specimen collection and related adverse reactions, and use contraceptives from 4 weeks before the beginning of the study to 4 weeks after the end of the study. Cohort 2: the effect of PD-1 monoclonal antibody on latent AIDS infection in patients with AIDS complicated with tumor. The main results were as follows: (1) inpatients aged 18 to 65 years old; (2) confirmed HIV infection by primary screening test and WB diagnostic test; (3) patients with diagnosed tumor were treated with PD-1 monoclonal antibody and willing to use it; (4) voluntarily signed the informed consent form of the patient, and could ensure regular follow-up, specimen collection and related adverse reactions. 

排除标准:

队列一:艾滋病合并隐球菌脑膜炎治疗效果不佳的患者免疫调节治疗 (1)妊娠、哺乳期妇女,或研究观察期内计划妊娠; (2)治疗依从性不良者; (3)筛选前6个月内接受过免疫抑制剂或其他免疫调节剂或细胞毒性药物治疗; (4)有严重的心、脑、肝肾等基础性疾病患者,中性粒细胞<1000/mm3,血小板<75000/mm3,对研究药物过敏或者其他治疗禁忌患者; (5)不愿意签署患者知情同意书。 队列二:艾滋病合并肿瘤患者使用PD-1单抗对艾滋病潜伏感染的影响 (1)治疗依从性不良者; (2)筛选前6个月内接受过免疫抑制剂或其他免疫调节剂或细胞毒性药物治疗; (3)有严重的心、脑、肝肾等基础性疾病患者,中性粒细胞<1000/mm3,血小板<75000/mm3,对研究药物过敏或者其他治疗禁忌患者; (4)不愿意签署患者知情同意书。 

Exclusion criteria:

Cohort 1: immunomodulatory therapy for patients with AIDS complicated with Cryptococcus meningitis (1) pregnancy, lactating women, or planned pregnancy during the observation period; (2) patients with poor compliance; (3) immunosuppressive agents or other immunomodulator or cytotoxicity drugs were treated within 6 months before screening; (4) patients with serious basic diseases such as heart, brain, liver and kidney, neutrophils < 1000 mm 3, platelets < 75 000 mm 3, allergic to drugs or other taboo treatments; (5) unwilling to sign informed consent form of patients; (6) patients with basic diseases such as heart, brain, liver and kidney, neutrophils < 1000 mm 3, platelets < 75 000 mm 3, allergic to drugs or other taboos in treatment. Cohort 2: the effect of PD-1 monoclonal antibody on latent AIDS infection in patients with AIDS complicated with tumor (1) treatment of patients with poor compliance; (2) immunosuppressive agents or other immunomodulators or cytotoxicity drugs were treated within 6 months before screening; (3) patients with serious basic diseases such as heart, brain, liver and kidney, neutrophils < 1000 mm 3, platelets < 75 000 mm 3, allergic to drugs or other taboo treatments; (4) unwilling to sign informed consent form of patients; (5) patients with basic diseases such as heart, brain, liver and kidney, neutrophils < 1000 mm 3, platelets < 75 000 mm 3, allergic to drugs or other treatment taboos. 

研究实施时间:

Study execute time:

From2019-06-01To 2020-12-31 

干预措施:

Interventions:

组别:

2

样本量:

24

Group:

2

Sample size:

干预措施:

来那度胺

干预措施代码:

Intervention:

lenalidomide

Intervention code:

组别:

1

样本量:

6

Group:

1

Sample size:

干预措施:

PD-1单抗

干预措施代码:

Intervention:

PD-1 monoclonal antibody

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲 

Institution
hospital:

the First Affiliated Hospital, College of Medicine, Zhejiang University  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

HIV DNA

指标类型:

主要指标 

Outcome:

HIV DNA

Type:

Primary indicator 

测量时间点:

筛选期,3周,7周,12周,24周,36周,48周

测量方法:

Measure time point of outcome:

In screening process, week 3, 7, 12, 24, 36, 48

Measure method:

指标中文名:

HIV RNA

指标类型:

主要指标 

Outcome:

HIV RNA

Type:

Primary indicator 

测量时间点:

筛选期,3周,7周,12周,24周,36周,48周

测量方法:

Measure time point of outcome:

In screening process, week 3, 7, 12, 24, 36, 48

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

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

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):

在当前研究期间使用和/或分析的数据集可在相应的作者的合理要求下获得

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

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

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:

EDC

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

EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-05-15
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