ChiCTR-TRC-13003140 版本V1.3 版本创建时间2016/1/28 20:56:16 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR-TRC-13003140 

最近更新时间:

Date of Last Refreshed on:

2016/1/28 20:54:13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

注射用艾博卫泰联合克力芝的比较药代动力学临床试验 

Public title:

Pharmacokinetic Study of Albuvirtide and Lopinavir/Ritonavir in HIV-infected Patients 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

注射用艾博卫泰联合克力芝的比较药代动力学临床试验 

Scientific title:

Pharmacokinetic Study of Albuvirtide and Lopinavir/Ritonavir in HIV-infected Patients 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

FB-ABWT-II-201 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

姚成 

研究负责人:

吴昊 

Applicant:

Cheng Yao 

Study leader:

Hao Wu 

申请注册联系人电话:

Applicant telephone:

+86 023 68885251 

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:

+86 023 68887671 

研究负责人传真:

Study leader's fax:

+86 010 63294417 

申请注册联系人电子邮件:

Applicant E-mail:

yaocheng@frontierbiotech.com 

研究负责人电子邮件:

Study leader's E-mail:

wuhdoc@public.bta.net.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:

重庆市高新区科园四街70号I座3楼 

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:

3rd Floor, Building I, 70 Keyuan 4th Street, High-Tech Zone, Chongqing, China 

Study leader's address:

Beijing YouAn Hospital, Capital medical university, 8 Waixitoutiao, You’an men, Fengtai district, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

400041 

研究负责人邮政编码:

Study leader's postcode:

100069 

申请人所在单位:

重庆市前沿生物技术有限公司 

Applicant's institution:

Frontier Biotechnonogies 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:

京佑伦字[2013]014 

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:

首都医科大学附属北京佑安医院伦理委员会 

Name of the ethic committee:

Ethic committee of Beijing YouAn Hospital, Capital medical university 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-03-28 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

2012-12-03

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 YouAn 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 Waixitoutiao, You’an men, Fengtai Dstrict, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆前沿生物技术有限公司

具体地址:

重庆市高新区科园四街70号I座3楼

Institution
hospital:

Frontier Biotechnologies Co.,Ltd

Address:

3rd Floor, Building I, 70 Keyuan 4th Street, High-Tech Zone, Chongqing, China

经费或物资来源:

重庆前沿生物技术有限公司 

Source(s) of funding:

Frontier Biotechnologies Co.,Ltd 

研究疾病:

艾滋病 

Target disease:

AIDS 

研究疾病代码:

B2401 

Target disease code:

B2401 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

I期+II期 

Study phase:

1-2 

研究目的:

主要目的:评价注射用艾博卫泰和LPV/RTV联合使用在稳态水平下的药物相互作用; 次要目的:评价注射用艾博卫泰和LPV/RTV联合治疗HIV感染者的安全性和耐受性; 次要目的:评价注射用艾博卫泰和LPV/RTV联合治疗HIV感染者的有效性; 

Objectives of Study:

Primary objective: Determine the effect of co-administration of LPV/RTV and Albuvirtide to their steady-state pharmacokinetics; Secondary objective: Evaluate the short-term safety and tolerability of co-adminstration of Albuvirtide and LPV/RTV in HIV-infected patients; Secondary objective: Evaluate the efficacy of co-adminstration of Albuvirtide and LPV/RTV in HIV-infected patients. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1). 18-50周岁,男女兼有。 2). HIV抗体确证试验阳性(W.B)或持有HIV感染者医疗证。 3). HIV病毒载量 ≥ 5000 copies/ ml,<1,000,000 copies/ ml。 4). CD4细胞计数 ≥350 cells/mm3(BD流式细胞仪)。 5). 经全面体检(包括一般体检,血尿常规,血生化检查、胸部X线、B超及心电图等),无严重肝肾功能损害、白蛋白值正常、其余各项指标均在基本正常范围者。 6). 停服抗HIV或抗肝炎病毒药物超过半年的HIV感染者或从未使用过抗HIV或抗肝炎病毒药物治疗的HIV感染者。 7). 体重达到40公斤以上,且体重指数在18.0-27.0 Kg/m2[BMI=体重/身高2]之间。 8). 同意在试验期间禁酒者。 9). 受试者应充分了解试验目的、性质、方法、以及可能发生的反应。自愿参加本试验并签署知情同意书。 

Inclusion criteria

1. Male or female patients aged 18 to 50 years old; 2. Previously documented HIV infection on standard antibody-based test; 3. HIV RNA >=5000, <1,000,000 copies/ml; 4. CD4+ cell count>=350/ul; 5. In a good healthy condition by physical examination, biochemistry, hematology and urinalysis test, chest X ray examination, B type ultrasonic examination and electrocardiogram etc., without serious liver and renal damages; albumin and other items are in normal range; 6. Naive to antiretroviral therapy or have stopped treatment for at least half a year; 7. Body weight ≥ 40 kg with BMI from 18 to 27 kg/m2; 8. Willingness to abstain from alcohol during the trial; 9. Fully understand the purpose, characteristics, procedures of the trial, as well as the adverse event which might occur during study; Willing and able to sign informed consent. 

排除标准:

1). 急性感染期患者。 2). 有严重机会性感染或机会性肿瘤。 3). 转氨酶超过正常值上限2倍,肌酐超过正常值上限,体检及其它生化、血尿常规检查显著异常者。 4). 现患有较严重慢性病、代谢性疾病(如糖尿病)、神经及精神疾病。 5). 既往曾患胰腺炎者。 6). A型及B型血友病患者。 7). 过敏体质或已知对本药品成分或方案规定的克力芝成分过敏者。 8). 妊娠期、哺乳期妇女和不能按要求进行避孕的育龄妇女。 9). 怀疑或确定有酒精、药物滥用病史。 10). 近三个月内参加过其他药物试验,或接受其他HIV融合抑制剂治疗,或参加过HIV疫苗试验者。 11). 筛选期前半年内接受过其他抗HIV药物治疗者。 12). 近3天内有发热疾病者。 13). 研究者认为任何不适于参加本项临床研究者。 

Exclusion criteria:

1. Patients with acute HIV infection; 2. With severe opportunistic infection or tumors; 3. ALT is 2-fold more than upper limit of normal value, or Creatinine is over upper limit of normal value, or other items are obviously abnormal; 4. With serious chronic disease, metabolic disease (such as diabetes), mental disorder and nervous disease; 5. Had a history of pancreatitis; 6. Had a history of hemophilia A or B; 7. With allergic constitution, or allergic history of the investigational drug and LPV/RTV; 8. Pregnant women, breast feeding women, and women in child-bearing age disagreed with use of birth control; 9. Alcohol abuse or drug abuse; 10. Received any other investigational drugs, HIV fusion inhibitors, or HIV vaccine within 3 months; 11. Received other anti-HIV medicine within half a year before screening; 12. Had a fever with 3 days prior to study entry; 13. Unsuitable to participate in this study in the opinion of the site investigator. 

研究实施时间:

Study execute time:

From2013-04-13To 2013-10-20 

干预措施:

Interventions:

组别:

A

样本量:

10

Group:

A

Sample size:

干预措施:

注射用艾博卫泰160mg + LPV/RTV, 连续给药46天

干预措施代码:

Intervention:

LPV/RTV and Albuvirtide at a dose of 160mg for 46 days

Intervention code:

组别:

B

样本量:

10

Group:

B

Sample size:

干预措施:

注射用艾博卫泰320mg + LPV/RTV, 连续给药46天

干预措施代码:

Intervention:

LPV/RTV and Albuvirtide at a dose of 320mg for 46 days

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:

卫生部三级甲等医院 

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:

药代动力学指标

指标类型:

主要指标 

Outcome:

Pharmacokinetics indexe

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性指标

指标类型:

次要指标 

Outcome:

Safety indexes

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HIV病毒载量

指标类型:

次要指标 

Outcome:

HIV RNA

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD4细胞计数

指标类型:

次要指标 

Outcome:

CD4 count

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:

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 50 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):

计算机软件

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

Computer software

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

药代动力学指标、HIV病毒载量、CD4计数及安全性指标

Calculated Results ater
the Study Completed:

Pharmacokinetics indexes, HIV RNA, CD4 count, and safety indexes

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

首都医科大学附属北京佑安医院

Data collection Institution:

Beijing YouAn Hospital, Capital medical university

资料管理单位:

首都医科大学附属北京佑安医院

Data management Institution:

Beijing YouAn Hospital, Capital medical university

资料分析单位:

上海中医药大学药物临床研究中心

Data analysis Institution:

Center for Drug Clinical Research, SUCM

注册人:

Name on Registration:

 2013-04-10