Today is 2019-08-21

Long-term effects of anti-retroviral therapy in acute HIV infection
download

注册号:

Registration number:

ChiCTR1800015006 

最近更新日期:

Date of Last Refreshed on:

2018-02-28 

注册时间:

Date of Registration:

2018-02-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

急性期HIV感染者长期抗病毒治疗研究 

Public title:

Long-term effects of anti-retroviral therapy in acute HIV infection 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

急性期HIV感染者长期抗病毒治疗研究 

Scientific title:

Long-term effects of anti-retroviral therapy in acute HIV infection 

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:

康婧 

研究负责人:

尚红 

Applicant:

Jing Kang 

Study leader:

Hong Shang 

申请注册联系人电话:

Applicant telephone:

+86 15840440390 

研究负责人电话:

Study leader's telephone:

+86 13704009520 

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:

dakangjing@126.com 

研究负责人电子邮件:

Study leader's E-mail:

hongshang100@hotmail.com 

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:

中国辽宁省沈阳市和平区南京北街155号 

研究负责人通讯地址:

中国辽宁省沈阳市和平区南京北街155号 

Applicant address:

155 Nanjingbei Street, Heping District, Shenyang, Liaoning, China 

Study leader's address:

155 Nanjingbei Street, Heping District, Shenyang, Liaoning, China 

申请注册联系人邮政编码:

Applicant postcode:

110001 

研究负责人邮政编码:

Study leader's postcode:

110001 

申请人所在单位:

中国医科大学附属第一医院检验科,卫生部艾滋病免疫学重点实验室 

Applicant's institution:

Key Laboratory of AIDS Immunology of National Health and Family Planning Commission, Department of Laboratory Medicine, The First Affiliated Hospital, China 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:

[2018]2015-138-5 

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:

中国医科大学附属第一医院 医学科学研究伦理委员会 

Name of the ethic committee:

Medical science research ethics committee of The First Affiliated Hospital, China Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-02-23 

伦理委员会联系人:

李鹏程,朱雷,佟建华 

Contact Name of the ethic committee:

Pengcheng Li,Lei Zhu, Jianhua Tong  

伦理委员会联系地址:

辽宁省沈阳市和平区南京北街155号,中国医科大学附属第一医院 

Contact Address of the ethic committee:

155 Nanjing Street North, Heping District, Shenyang, Liaoning, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 024-83282837 

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:

中国医科大学附属第一医院检验科,卫生部艾滋病免疫学重点实验室 

Primary sponsor:

Key Laboratory of AIDS Immunology of National Health and Family Planning Commission, Department of Laboratory Medicine, The First Affiliated Hospital, China Medical University 

研究实施负责(组长)单位地址:

中国辽宁省沈阳市和平区南京北街155号,110001  

Primary sponsor's address:

155 Nanjingbei Street, Heping District, Shenyang, Liaoning, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

“十三五”国家科技重大专项课题 

Source(s) of funding:

the Mega-Projects of national science research for the 13th Five-Year Plan  

研究疾病:

HIV感染 

Target disease:

HIV infections 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

1 明确长期抗病毒治疗对HIV急性期感染者的病毒学、免疫学指标影响,为HIV早期和急性期感染者长期接受抗病毒治疗提供科技支撑; 2 采用数学模型分析高效抗反转录病毒治疗HIV急性期感染者HIV病毒载量及病毒储存库的变化特征。 

Objectives of Study:

We have two specific objectives: 1. To clarify the immuno-virologic outcomes of long-term anti-retroviral therapy which is initiated during acute HIV infection, so as to provide technical support for long-term anti-retroviral therapy in acute HIV infection; 2. To analyze how viral load and reservoir change in patients who received highly active anti-retroviral therapy during acute HIV infection in a mathematical model. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1. 来自于“十二五”期间在中国医科大学附属第一医院和北京佑安医院接受抗病毒治疗并维持随访的HIV急性期感染者队列,治疗1年以上。 2. 男性,自报有男男同性行为。 3. 年龄 18-65 岁。 4. 自愿签署患者知情同意书,并能保证接受随访。 5. 在试验进行过程中无计划迁离当前的试验地点。  

Inclusion criteria

1. Patients who initiated anti-retroviral therapy during acute HIV infection (enrolled in ChiCTR-ONRC-13003483) and maintained follow up and treatment for more than one year; 2. Male, with self-reported sexual behavior with men; 3. Aged 18-65 years old; 4. Subjects who signed the informed consent and would like to follow up; 5. Subjects with no plan to resettle during the trial. 

排除标准:

1. 同时参加任何其他HIV干预研究或试验性药物研究 2. 智力障碍或不能与医生有效交流者 3. 严重酗酒者 4. 非中国国籍人员 

Exclusion criteria:

1. Patients who participate in any other HIV intervention study or experimental drug study; 2. Patients with mental retardation or cannot communicate with their doctors; 3. Serious alcoholics; 4. Not of Chinese nationality. 

研究实施时间:

Study execute time:

From2018-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

长期治疗组

样本量:

200

Group:

Long-term treatment Group

Sample size:

干预措施:

2个核苷类反转录酶抑制剂(替诺福韦+拉米夫定)+依非韦伦 或 洛匹那韦利托那韦片

干预措施代码:

Intervention:

2NRTIs (TDF+3TC)+EFV or LPV/r

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

中国医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital, China Medical University  

Level of the institution:

Tertiary A Hospital 

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:

三级甲等 

Institution
hospital:

Beijing YouAn Hospital, Capital Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

HIV病毒载量

指标类型:

主要指标 

Outcome:

HIV viral load

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD4T细胞计数

指标类型:

主要指标 

Outcome:

CD4 T cell count

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HIV病毒储存库

指标类型:

次要指标 

Outcome:

HIV reservoir

Type:

Secondary 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

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

精液

组织:

Sample Name:

Sperm

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

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:

脑脊液

组织:

Sample Name:

Cerebrospinal fluid

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

非随机

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

No

盲法:

非盲法

Blinding:

No-blinding

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

于项目结束后2021年6月,共享数据

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

We are going to sharing IPD in June,2021.

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:

我们采用电子病例记录表保存数据,用电子采集和管理系统进行管理

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

We will collect data with electronic CRF, and manage with an electronic data capture system

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-02-28
return list