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两种口服Truvada方式预防中国男男性行为者HIV感染的多中心真实世界研究
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注册号:

Registration number:

ChiCTR-IIN-17013762 

最近更新日期:

Date of Last Refreshed on:

2018-07-28 

注册时间:

Date of Registration:

2017-12-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

两种口服Truvada方式预防中国男男性行为者HIV感染的多中心真实世界研究 

Public title:

A multicenter, real-world study on two oral Truvada approaches to prevent HIV infection among MSM in China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

两种口服Truvada方式预防中国男男性行为者HIV感染的多中心真实世界研究 

Scientific title:

A multicenter, real-world study on two oral Truvada approaches to prevent HIV infection among MSM in China (CROPrEP) 

研究课题代号(代码):

Study subject ID:

2017ZX10201101 

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:

徐俊杰 

研究负责人:

尚红 

Applicant:

Junjie Xu 

Study leader:

Hong Shang 

申请注册联系人电话:

Applicant telephone:

+86 15002476278 

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:

xjjcmu@163.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:

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,卫计委艾滋病免疫学重点实验室 

研究负责人通讯地址:

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,卫计委艾滋病免疫学重点实验室 

Applicant address:

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

Study leader's address:

The First Affiliated Hospital, China Medical University, No 155, Nanjingbei Street, Heping District, Shenyang, Liaoning Province, 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,卫计委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]2015-139-5 

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:

2018-07-24 

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,卫计委艾滋病免疫学重点实验室 

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 

Primary sponsor:

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,中国医科大学附属第一医院 

Primary sponsor's address:

155 Nanjing Street North, Heping District, Shenyang, Liaoning, 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):

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

具体地址:

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

Institution
hospital:

The First Affiliated Hospital, China Medical University

Address:

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

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:

艾滋病病毒/艾滋病 

Target disease:

HIV/AIDS 

研究疾病代码:

 

Target disease code:

 

研究类型:

预防性研究 

Study type:

Prevention 

研究所处阶段:

IV期临床试验 

Study phase:

研究目的:

主要研究目的:评估两种不同的PrEP策略降低中国MSM人群HIV新发感染的效果; 次要研究目的: 明确影响中国MSM人群PrEP服药依从性的因素; 了解PrEP队列随访中性行为变化趋势和性病新法感染率; 为中国MSM的HIV防控工作提供更好的证据 

Objectives of Study:

Primary Objective: To evaluate the efficacy of the two different PrEP strategies to decrease HIV incidence for MSM in China. Secondary Objective(s): To confirm risk factors of acceptance and adherence of PrEP among Chinese MSM. To understand the trend of sexual behaviors and STIs incidence during the PrEP cohort follow-up. To provide evidences for better prevention of HIV among MSM in China. 

药物成份或治疗方案详述:

多中心临床试验研究计划在中国沈阳、北京、深圳、重庆四座主要城市开展,以真实世界开放标签方式建立2个平行干预组(Truvada每日服药组,和Truvada事件驱动服药组),旨在评价Truvada不同服药方式对预防中国MSM人群HIV新发感染的效果。每组各有500名研究对象。 以上1000名MSM研究对象共随访12月,每3个月随访一次。日服服药组,500人,每天服用1片Truvada。事件驱动服药组,500人,在性行为2-24小时服药2片Truvada,在首次服药后的第24小时和第48小时各服用一片Truvada。每次随访向所有参加者免费提供安全套和润滑剂并提供检测检测前后咨询。在入组和每次随访时向受试者发放Truvada药片。每次随访对受试者进行血药浓度检测,生物学指标,肝肾功能检测。在研究过程对受试者进行三次HBV、HCV,和骨密度检测。 

Description for medicine or protocol of treatment in detail:

This trial will be performed in four major cities in China, which are Shenyang, Beijing, Shenzhen, and Chongqing. This Multicenter open-label trial is composed of two parallel intervention groups (daily-intake Truvada group and Event-driven-intake Truvada group), to evaluate the efficacy of HIV prevention of Truvada among MSM in China by different intake strategies. Each group will have 500 participants separately. All the 1000 participants will be followed-up for 12 months, with a follow-up frequency of once per every 3 months. For the daily-intake group, 500 subjects intake 1 tablet of Truvada daily. For the event-driven group, 500 subjects intake two pills of truvada 2-24 hours before each sexual intercourse, followed by two single doses of truvada, 24 and 48 hours after the first drug intake, orally. Every subject in intervention groups will received Truvada pills at the enrollment and every follow-up visit. Condom and lubricate will be provided at every visit for all participants. HIV RNA, HIV antibody and syphilis will be screened among all subjects at recruitment, enrollment and every follow-up visit. Drug concentrate, biochemical indicators, liver and renal functions will be tested for all subjects at every follow-up visit. HBV, HCV bone mineral density test will be provided at least three times during the study progress.  

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

(1)年龄在18-65周岁; (2)未感染HIV-1或HIV-2; (3)出生时性别为男性有男男性行为者,且在入选前6个月有以下一种或多种危险性行为者: a.发生过无保护被插入式肛交; b.在入选前6个月的性伴总数在2个以上; c.自报有梅毒、生殖器疱疹、淋病、衣原体感染,软下疳,或性病性淋巴肉芽肿等性病感染; d.曾经有HIV暴露后预防用药史。 注:与一名HIV-1血清学阴性,或者病毒学抑制的HIV-1阳性感染者伴侣有一年以上的单一性伴侣关系的受试者不得参加研究。 (4)经过全面的临床检查(包括定期检查、尿液、血液检查等),没有严重的肝肾功能障碍,以及乙型肝炎表面抗体和丙型肝炎抗体检测呈阴性,且其他指标正常。 (5)全面了解试验目的、设计、可能的结局事件后,自愿参加研究,并签署知情同意者。 

Inclusion criteria

1. Aged 18-65 years old; 2. Not infected with HIV-1 or HIV-2; 3. Participants of male sex at birth and who have sex with men, who in the 6 months. prior to screening report one or more of the following risk criteria: (1) Unprotected (condomless) receptive anal intercourse with one or more partners; (2) More than two male partners in the 6 months prior to enrolment (regardless of condom use and HIV serostatus, as reported by the enrolee). (3) Reported STI with syphilis, HSV-2gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum; (4) Reported a history of Post-exposure prophylaxis(PEP). Note: Participants in a monogamous relationship with an HIV-1 seronegative partner or a virologically-suppressed HIV-1 + partner for > 1 year are not eligible for participation; 4. Through comprehensive physical examination (including a regular checkup, urinalysis, blood biotest, ECG, et al.). No serious liver or kidney dysfunction, negative HBs antigen and negative hepatitis C virus (HCV) serologyosteoporosisand other indicators are normal; 5. The subjects be able to fully understand the study objects, design and possible outcomes of the study, and volunteered to join and can provide signed informed consent. 

排除标准:

(1)过敏体质或对实验药物和ART成分过敏的人。 (2)严重慢性病,代谢性疾病(如糖尿病),神经精神障碍患者。 (3)不适合入选的个人(如生病或依从性差)。 (4)用干扰素,白细胞介素或抗逆转录病毒治疗。 

Exclusion criteria:

(1) Allergy physique or people who are allergic to the ingredients of the experiment drug and ART; (2) People who are suffering serious chronic diseases, metabolic diseases (such as diabetes), neurological and psychiatric disorders; (3) Individuals who are unsuitable for enrollment (such as illness, or have poor adherence); (4) Treatment with Interferon, Interleukin, or antiretrovirals. 

研究实施时间:

Study execute time:

From2018-09-01To 2020-12-31 

干预措施:

Interventions:

组别:

事件驱动服药组

样本量:

500

Group:

Event-driven intake group

Sample size:

干预措施:

性行为开始前2-24小时内,口服2片Truvada,在首次服药后第24小时和第48小时各口服一片Truvada。

干预措施代码:

Intervention:

Two tablets of truvada 2-24 hours before each sexual intercourse, followed by two single doses of truvada, 24 and 48 hours after the frst drug intake

Intervention code:

组别:

每日服药组

样本量:

500

Group:

Daily intake group

Sample size:

干预措施:

每24小时口服1片

干预措施代码:

Intervention:

One tablet of truvada every 24 hours, orally

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 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

深圳市第三人民医院 

单位级别:

三级甲等 

Institution
hospital:

The Third People's hospital of Shenzhen  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市公共医疗卫生救治中心 

单位级别:

三级乙等 

Institution
hospital:

Chongqing Infectious Disease Medical center  

Level of the institution:

Tertiary B hospital 

测量指标:

Outcomes:

指标中文名:

HIV新发感染率

指标类型:

主要指标 

Outcome:

HIV incidence

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

梅毒新发感染率

指标类型:

次要指标 

Outcome:

syphilis incidence

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生殖器疱疹新发感染率

指标类型:

次要指标 

Outcome:

HSV-2 incidence

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:

静脉血

组织:

血液

Sample Name:

Venous blood

Tissue:

blood

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:

尿液

Sample Name:

Urine

Tissue:

Urine

人体标本去向

使用后保存 

说明

5年

Fate of sample:

Preservation after use 

Note:

five years

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

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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:

数据的采集和管理由电子问卷收集和管理系统完成。

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

Data collection and Management are both conducted by a electronic questionnaire collection and management system.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-12-08
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