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Phase 3 Efficacy and Safety Study of ACC007 Combined with 3TC+TDF in the Treatment of HIV/AIDS
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注册号:

Registration number:

ChiCTR1800019041 

最近更新日期:

Date of Last Refreshed on:

2019-07-19 

注册时间:

Date of Registration:

2018-10-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

ACC007片联合3TC+TDF治疗HIV/AIDS的有效性和安全性 

Public title:

Phase 3 Efficacy and Safety Study of ACC007 Combined with 3TC+TDF in the Treatment of HIV/AIDS 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

ACC007片联合3TC+TDF治疗HIV/AIDS的有效性和安全性 

Scientific title:

Phase 3 Efficacy and Safety Study of ACC007 Combined with 3TC+TDF in the Treatment of HIV/AIDS 

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:

沈小宁 

研究负责人:

吴昊 

Applicant:

Xiaoning Christopher Sheng 

Study leader:

Hao Wu 

申请注册联系人电话:

Applicant telephone:

+86 0514-87530666 

研究负责人电话:

Study leader's telephone:

+86 010-63053963 

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:

Chris.sheng@wmic.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

whdoc@sina.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:

江苏省扬州市邗江区刘庄路2号 

研究负责人通讯地址:

北京市丰台区右安门外西头条8号 

Applicant address:

2 Liuzhuang Road, Hanjiang District, Yangzhou, Jiangsu, China 

Study leader's address:

8 West Tou Tiao, Youanmeiwai, Fengtai District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

225008 

研究负责人邮政编码:

Study leader's postcode:

100069 

申请人所在单位:

江苏艾迪药业有限公司 

Applicant's institution:

Jiangsu Aidea Pharmaceutical Co.,Ltd 

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:

2018-077 

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:

首都医科大学附属佑安医院伦理委员会 

Name of the ethic committee:

Ethics Committee(seal)of Beijing YouAn Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-09-21 

伦理委员会联系人:

吴昊 

Contact Name of the ethic committee:

Hao Wu 

伦理委员会联系地址:

北京市丰台区右安门外西头条8号 

Contact Address of the ethic committee:

Beijing YouAn Hospital, Capital Medical University, 8 West Tou Tiao, Youanmeiwai, Fengtai District, Beijing, 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:

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西头条8号 

Primary sponsor's address:

8 West Tou Tiao, Youanmeiwai, Fengtai District, 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):

江苏

市(区县):

扬州

Country:

China

Province:

Jiangsu

City:

Yangzhou

单位(医院):

江苏艾迪药业有限公司

具体地址:

江苏省扬州市邗江区刘庄路2号

Institution
hospital:

Jiangsu Aidea Pharmaceutical Co.,Ltd

Address:

2 Liuzhuang Road, Hanjiang District, Yangzhou, Jiangsu, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

非核苷类逆转录酶抑制剂,与其他抗逆转录病毒药物联合治疗HIV/AIDS 

Target disease:

Non-nucleoside reverse transcriptase inhibitors,and other antiretroviral drugs in combination with HIV/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:

III期临床试验 

Study phase:

研究目的:

评价ACC007片联合3TC+TDF治疗的HIV/AIDS的有效性和安全性 

Objectives of Study:

To evaluate efficacy and safety of ACC007 combined with 3TC+TDF in the treatment of HIV/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:

(1) 年龄18-65岁 (2) 确诊为HIV-1感染,入选前30天的HIV RNA≥1000 copies/ml且研究者判断受试者适合接受ART方案 (3) 从未接受过ARV或HIV治疗性疫苗且同意基线访视前不开始ART (4) 能够理解并遵守研究方案要求,且自愿签署书面的知情同意书者 

Inclusion criteria

1. Male or female between 18 to 65 years of age; 2. Diagnosed as HIV-1 infection, HIV RNA 1000 copies/ml in the 30 days prior to the enrollment and the investigator judged that the subject was eligible for ART (Antiretroviral Therapy); 3. Never received an ARV or HIV therapeutic vaccine and agreed not to start ART before the baseline; 4. Cognitive ability to understand and provide written informed consent and willingness to participate in and comply with the study protocol. 

排除标准:

(1) HIV-1急性感染期或目前正患有AIDS相关疾病 (2) 有吸毒史、近期有酒精或药物依赖史者 (3) 任何研究者认为可能会危及受试者安全的状况,影响对试验方案的依从性 (4) 在入选本研究前30天内参加过其他药物或治疗性器械临床试验者 (5) 在本研究的治疗前30天内使用过系统性免疫抑制治疗或免疫调节剂,或在临床试验期间不能避免使用者 (6) 丙肝患者或谷丙转氨酶>4倍ULN的乙肝患者 (7) 肌酐≥ULN且根据CKD-EPI肌酐公式[1]推算的肾小球滤过率(GFR)≤60(ml/minute/1.73 m2)者(GFR=a*(serum creatinine)/b)^c*(0.993)^age。a值根据性别与人种:黑人:女性=166,男性=163;白人及其他人种:女性=144,男性=141。b值根据性别不同:女性=0.7;男性=0.9。c值根据性别与血清肌酐值不同:女性:血清肌酐≤0.7 mg/dL时c=-0.329,血清肌酐>0.7 mg/dL时c=-1.209;男性:血清肌酐≤0.7 mg/dL时c=-0.411,血清肌酐≤0.7 mg/dL时c=-1.209。) (8) 按照DAIDS分级表[2],任何有3或4级表现者 (9) 在筛选时受试者有活动性肺结核并且正在进行治疗(在试验期间出现活动性肺结核的受试者将退出治疗以便开始抗结核药治疗) (10) 在筛选前14天内曾服用或正在服用抗真菌类、皮质激素类药物,以及磺胺类和抗结核药物者 (11) 对研究药物的任何成分或辅料有过敏史或高敏体质者 (12) 妊娠或哺乳期妇女;未采取研究者认为有效的避孕措施(例如避孕隔膜;避孕套;宫内节育器等;伴侣输精管结扎)的育龄女性;筛选后至在末次服用试验药物后6个月内不愿继续采用研究者认可的避孕方式避孕的女性受试者。未行输精管切除术的有活动性异性性行为的男性中,没有采取生育控制措施的,或不愿在试验期间至试验结束后至少30天内继续采取避孕措施的男性受试者。 

Exclusion criteria:

(1) Patients in the acute infection period of HIV-1, or have AIDS-related diseases; (2) History of drug abuse, recent history of alcohol or drug dependence; (3) Patients, in the opinion of the investigator, is likely to be hazard for his/her safety, and can't comply with the protocol; (4) Patients who participated in other drug or therapeutic device clinical trials within 30 days prior to enrollment (5) Patients who received systemic immunosuppressive therapy or immunomodulatory agents within 30 days prior to enrollment, or can not avoid using such agents during clinical trials; (6) Patients with Hepatitis C or hepatitis B virus infection with Alanine aminotransferase > 4 times of ULN; (7) Patients with Creatinine >=ULN and glomerular filtration rate (GFR) <=60 (ml/minute/1.73 m2) calculated according to CKD-EPI creatinine formula [1] (GFR=a*(serum creatinine)/b)^c* (0.993)^age. a value- according to gender and race: Black: female = 166, male = 163; White and other species: female = 144, male = 141. b value- varies according to gender: female = 0.7; male = 0.9. c value-differs from the serum creatinine value by gender: female: c=-0.329 when serum creatinine <=0.7 mg/dL, c=-1.209 when serum creatinine>0.7 mg/dL; male: serum creatinine <=0.7 mg/dL c= -0.411, c=-1.209 when serum creatinine <=0.7 mg/dL); (8) According to the DAIDS rating scale [2], any patient with a level 3 or 4 performance; (9) Patients have active tuberculosis at the time of screening and are undergoing treatment (Patients with active tuberculosis during the clinical trials will withdraw in order to begin anti-tuberculosis treatment); (10) Patients who took or were taking antifungal, corticosteroids, and sulfonamides and anti-tuberculosis drugs within 14 days prior to screening; (11) Patients with history of allergies or hypersensitivity to any ingredients or excipients of the study drug; (12) Pregnant or breast-feeding women; women of childbearing age who did not consider effective contraceptive measures (eg. contraceptive diaphragm; condom; intrauterine device; partner vasectomy). After screening and within 6 months after the last dose of the test drug, Female patients who were reluctant to continue to use the contraceptive method approved by the investigator. Among men with active heterosexual behavior who did not undergo vasectomy, male patients who did not take birth control measures or who were unwilling to continue using contraception during the trial period and at least 30 days after the end of the trial. 

研究实施时间:

Study execute time:

From2018-11-01To 2021-09-01 

干预措施:

Interventions:

组别:

ACC007 150 mg + EFV模拟剂 +(3TC 300mg+TDF 300mg)

样本量:

315

Group:

Group 1

Sample size:

干预措施:

口服,一天一次,每次ACC007 150mg+EFV模拟剂 1片+3TC 300mg+TDF 300mg;盲治疗期第0周至第48周,开放治疗期第48周至第96周。

干预措施代码:

Intervention:

Oral administration, once a day, ACC007 150mg + EFV placebo 1 tablet + 3TC 300mg + TDF 300mg. Blinding treatment period: Week 0 to Week 48; Open treatment period: Week 48 to Week 96

Intervention code:

组别:

EFV 600mg +ACC007模拟剂 +

样本量:

315

Group:

Group 2

Sample size:

干预措施:

口服,一天一次,每次EFV 600mg+ACC007 1片+3TC 300mg+TDF 300mg;盲治疗期第0周至第48周,开放治疗期第48周至第96周。

干预措施代码:

Intervention:

Oral administration, once a day, EFV 600mg + ACC007 placebo 1 tablet + 3TC 300mg + TDF 300mg. Blinding treatment period : Week 0 to Week 48; Open treatment period: Week 48 to Week 96

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:

三级甲等医院 

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:

HIV RNA<50 copies/ml的受试者百分比

指标类型:

主要指标 

Outcome:

Patients' Percentage of HIV RNA <50 copies/ml

Type:

Primary indicator 

测量时间点:

48周

测量方法:

Measure time point of outcome:

48 week

Measure method:

指标中文名:

①HIV RNA对数值及CD4细胞计数的变化;②HIV RNA≤400 copies/ml的受试者百分率;③HIV RNA<50 copies/ml的受试者百分比;④安全性

指标类型:

次要指标 

Outcome:

1. Changes of HIV RNA log values and CD4 cell counts; 2. Patients' percentage of HIV RNA ≤ 400 copies/ml; 3. Patients' percentage of HIV RNA <50 copies/ml; 4. Safety

Type:

Secondary indicator 

测量时间点:

①②治疗48周及96周;③治疗96周;④治疗24、48及96周

测量方法:

Measure time point of outcome:

1. treatment Week 48 and Week 96; 2. treatment 96 Week; 3. treatment 24, 48 and 96 Week

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:

结束

Completed

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):

计算机上采用SAS9.4统计软件包,试验组和对照组按1:1的比例用中央区组随机化方法产生随机号

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

The randomization was performed by computer software SAS9.4. Block randomization was used.

盲法:

Double blind

Blinding:

Double blind

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):

ResMan临床试验公共管理平台(http://www.medresman.org/login.aspx)

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

ResMan(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:

采用上海中医药大学药物临床研究中心与北京博之音科技有限公司的EDC系统进行数据录入、管理。

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

EDC system of Traditional Chinese Medicine Clinical Research Center in Shanghai University and Beijing Bozhiyin Teachnology Co.,Ltd,is used for data entry and data management。

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-10-23
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