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A real world study for a simplified regimen of dolutegravir combined with lamivudine in the treatment of newly infected HIV patients
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注册号:

Registration number:

ChiCTR1900027640 

最近更新日期:

Date of Last Refreshed on:

2019-11-22 

注册时间:

Date of Registration:

2019-11-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

多替拉韦钠联合拉米夫定简化方案治疗初治HIV感染者的真实世界研究 

Public title:

A real world study for a simplified regimen of dolutegravir combined with lamivudine in the treatment of newly infected HIV patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

多替拉韦钠联合拉米夫定简化方案治疗初治HIV感染者的真实世界研究 

Scientific title:

A real world study for a simplified regimen of dolutegravir combined with lamivudine in the treatment of newly infected HIV patients 

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:

洪仲思 

研究负责人:

夏瑾瑜 

Applicant:

Zhongsi Hong 

Study leader:

Jinyu Xia 

申请注册联系人电话:

Applicant telephone:

+86 13926931110 

研究负责人电话:

Study leader's telephone:

+86 13823078064 

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:

home503@126.com 

研究负责人电子邮件:

Study leader's E-mail:

lisideng@foxmail.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:

广东省珠海市香洲区梅华东路52号 

研究负责人通讯地址:

广东省珠海市香洲区梅华东路52号 

Applicant address:

52 Meihua Road East, Zhuhai, Guandong, China 

Study leader's address:

52 Meihua Road East, Zhuhai, Guandong, China 

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:

中山大学附属第五医院 

Applicant's institution:

The Fifth Affiliated Hosipital Of Sun Yat-sen 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:

中大五院(2019)伦字第(K16-1)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:

中山大学附属第五医院伦理委员会 

Name of the ethic committee:

Ethics Committee of The Fifth Affiliated Hosipital Of Sun Yat-sen University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-30 

伦理委员会联系人:

宋蕾 

Contact Name of the ethic committee:

Lei Song 

伦理委员会联系地址:

广东省珠海市香洲区梅华东路52号 

Contact Address of the ethic committee:

52 Meihua Road East, Zhuhai, Guandong, 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:

中山大学附属第五医院 

Primary sponsor:

The Fifth Affiliated Hosipital Of Sun Yat-sen University 

研究实施负责(组长)单位地址:

广东省珠海市香洲区梅华东路52号 

Primary sponsor's address:

52 Meihua Road East, Zhuhai, Guandong, 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):

广东省

市(区县):

Country:

China

Province:

Guangdong province

City:

单位(医院):

中山大学附属第五医院

具体地址:

广东省珠海市香洲区梅华东路52号

Institution
hospital:

The Fifth Affiliated Hosipital Of Sun Yat-sen University

Address:

52 Meihua Road East, Zhuhai, Guandong, China

经费或物资来源:

医院资助和自筹 

Source(s) of funding:

Hospital funding and self-finacing  

研究疾病:

艾滋病 

Target disease:

HIV/AIDS 

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:

观察多替拉韦钠联合拉米夫定简化治疗方案治疗HIV-1感染者的疗效和安全性 

Objectives of Study:

To observe the efficacy and safety of a simplified regimen of dolutegravir combined with lamivudine in the treatment of HIV-1 patients 

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.年龄≥18岁,男女不限 2.确认为HIV-1感染者; 3.根据临床判断可以使用简化治疗方案DTG+ 3TC的患者,原因不限,如(但不限于)患者不能耐受国家一线治疗方案,因肾功能不全或骨质疏松无法使用国家标准三药治疗方案的患者; 4. HIV-RNA病毒载量及CD4细胞计数不限; 5.第1年至少能检测3次CD4(包括基线、治疗24周)。以后至少每半年检测1次CD4; 6.已签署治疗知情同意书 

Inclusion criteria

1. Aged >=18 years old, male or female; 2. Confirmed HIV-1 infection; 3. judgment, for any reason. For example, (but not limited to) patients who cannot tolerate the national first-line treatment regimen and cannot use the national standard three-drug treatment regimen due to renal insufficiency or osteoporosis; 4. HIV-RNA iral load and CD4 cell count were not limited; 5. CD4 can be detected at least 3 times in the first year (including baseline and 24 weeks of treatment).CD4 should be tested at least once every six months; 6. informed consent for treatment has been signed. 

排除标准:

1.参加过HIV疫苗临床试验或近三个月内参加过其他药物试验; 2.加入试验前一年内有药物成瘾的证据(包括过多的酒精摄入); 3.有明确DTG或3TC过敏史; 4.乙肝表面抗原(HBsAg)和/或HBV-DNA阳性者; 5.妊娠妇女或哺乳期妇女; 6.有其他导致慢性肝病的病史或证据(例如血色病、自身免疫性肝炎、酒精性肝病、暴露于毒物、地中海贫血); 7.严重的精神疾病病史,特别是抑郁症的病史。严重的精神疾病是指在过去的任何时间内分别接受过至少3个月的抗抑郁药物,或用于治疗抑郁症或精神病的; 8.治疗剂量的镇静剂,或有任何以下病史:自杀企图,因精神疾病住院治疗,由于精神疾病的原因在一段时间内丧失劳动能力; 9.严重的癫痫病史或当前正接受镇静剂治疗; 10.免疫介导性疾病,或其他重度疾病、恶性疾病的证据,或该患者的其他条件使得研究者认为其不适合参加本次研究; 11.研究者判断,患者无法完成预定的随访(如体弱、依从性差等); 12.不能或不愿提供知情同意书或遵守试验要求。 

Exclusion criteria:

1. participated in clinical trials of HIV vaccine or other drug trials within the past three months; 2. evidence of drug addiction (including excessive alcohol intake) in the year prior to the trial; 3. a clear history of DTG or 3TC allergy; 4. hepatitis B surface antigen (HBsAg) and/or HBV-DNA positive; 5. pregnant or lactating women; 6. other history or evidence of chronic liver disease (e.g. hemochromia, autoimmune hepatitis, alcoholic liver disease, toxic exposure, thalassemia); 7. a history of serious mental illness, especially depression.A serious mental illness is one that has been on antidepressants or used to treat depression or mental illness for at least three months at any time in the past; 8. therapeutic doses of sedatives, or any history of suicide attempts, hospitalization for mental illness, incapacity to work for a period of time due to mental illness; 9. a history of severe epilepsy or currently being treated with sedatives; 10. immune-mediated disease, or evidence of other severe or malignant diseases, or other conditions of the patient that make the investigator consider him/her unsuitable to participate in this study; 11. the researcher judged that the patients could not complete the scheduled follow-up; 12. inability or unwillingness to provide informed consent or comply with test requirements. 

研究实施时间:

Study execute time:

From2019-12-01To 2021-08-31 

干预措施:

Interventions:

组别:

Case series

样本量:

30

Group:

Case series

Sample size:

干预措施:

多替拉韦 50mg +拉米夫定 300mg 每日1次

干预措施代码:

Intervention:

DTG 50mg +3TC 300mg once a day

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

 

Country:

China 

Province:

Guangdong province 

City:

 

单位(医院):

中山大学附属第五医院 

单位级别:

三级甲等 

Institution
hospital:

The Fifth Affiliated Hosipital Of Sun Yat-sen University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

病毒学突破率(HIV RNA <400 copies/mL)

指标类型:

主要指标 

Outcome:

Virological breakthrough rate (HIV RNA <400 copies/mL)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD4+T淋巴细胞计数

指标类型:

主要指标 

Outcome:

CD4+T lymphocyte count

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

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 years
最大 Max age 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):

开放性,单臂研究

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

N/A, open-label, single-arm clinical trial

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

本临床试验所获原始数据将于本试验结束后6个月内在临床试验公共管理平台ResMan(www.medresman.org)进行共享

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

The original data collected in this study will be shared in 6 months after the end of this study at the Clinical Trial Management Public Platform (www.medresman.org).

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:

病例记录表和临床试验公共管理平台ResMan

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

Case record form and Clinical Trial Management Public Platform.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-22
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