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中国综合性艾滋病研究项目


中国综合性艾滋病研究项目
China Integrated Programs for Research on AIDS (China CIPRA)
美国国立卫生研究院国际综合性艾滋病研究计划资助 Comprehensive International Program of Research on AIDS

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Outline of China CIPRA
? CIPRA: Comprehensive International Program of Research on AIDS ? Sponsor: National Institute of Health, USA ? Corporation: National Center for STD/AIDS prevention and control, China CDC ? Period: July 1, 2002 to June 30, 2007 ? Budget: $15 millions ? Project provinces: Shanxi and Yunnan
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Overall Goal
? To strengthen the existing HIV/AIDS research infrastructure in China and build the capacity to conduct multidisciplinary research to explore promising strategies for HIV/AIDS prevention, treatment and control.

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Research Group
? The China CIPRA project is composed of 143 research staffs and 12 international consultants. ? The China CIPRA team is composed of 24 collaborating organizations including 13 domestic research institutes, 2 universities, and 2 hospitals, as well as 5 international universities and 2 research institutions.
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Research Activity (I)
1. To estimate the prevalence and incidence of HIV-1 infection and to determine risk factors. 2. To evaluate the efficacy of more intensive, theoretically-based HIV skill-focused interventions for HIV+ adults. 3. To study viral and host factors that correlate with transmission of infection and factors that determine disease progression; and identify the immunodominant CTL epitopes and their MHC restricting elements in the most prevalent Chinese HIV subtypes as well as provide reagents for these studies. 5

Research Activity (II) 4. To characterize the clinical presentations of AIDS patients in China, to conduct clinical trials of antiviral drugs; 5. To develop vaccine candidates based on the Chinese prevalent strains and to conduct Phase I and Phase II clinical trials to evaluate its safety, immunogenicity and preliminary efficacy.

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Research Team of China CIPRA
China CIPRA
P I : Yiming Shao Co-PI : Dexian Zheng , Zunyou Wu Advisor: Yi Zeng

Core A (Administration and training)
Leader: Yiming Shao Co-Leader: Dexian Zheng Zunyou Wu Xiaoyan Zhang

Core B
(Statistical and Data Management) Leader: ShuiGao Jin Co-Leader: Hui Li Yuhua Ruan Consultant: Steve Self

Core C (Central Laboratory)
Leader: Yan Jiang Co-Leader: DeXian Zheng Consultant: Haynes W. Sheppard Huyen Cao

Core D (Primate)
Leader: Fude Fang Co-Leader: QiHan Li XinMing Tu Consultant: Ruth Ruprecht, Harold M.McClure, Xiaofang Yu

Project 1 (Epidemiology)
Leader: Xiwen Zheng Co-Leader: Zunyou Wu Lü Fan Shenghan Lai

Project 2 (Behaviroal Intervention)
Leader: Zunyou Wu Co-Leader and Consultant: Roger Detels Rotheram-Borus Mary Jane

Project 3
(Viral Immune Corrlates of
Transmission and Progression)

Project 4 (Clinical Research)
Leader: Yunzhen Cao Co-Leader: Taisheng Li Linqi Zhang Xiaoping Chen Consultant: David Ho

Project 5
(Development of a novel vaccine against HIV/AIDS in China) Leader: Li Ruan Co-Leader: Yiming Shao Wei He Yichen Lu Xiaofang Yu

Consultant: Sten Vermund
Roger Detels , ShenhanLai

Leader: Yiming Shao Co-Leader: Yunqi Geng Judy Lieberman Kunxue Hong , Xing Hui Consultant: Haynes W.Sheppard Huyen Cao

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CIPRA Coordinating Committee(CCC) ( )
? The CCC is responsible for supervising the general research direction according to the goals of Chinese AIDS control and prevention effort. It will provide guidance and support for the implementation of the China CIPRA research protocol and schedule. In addition, the committee will translate the experiences and results of the China CIPRA program to help advance AIDS research throughout the country.
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Scientific Advisory Board (SAB)
? Made up of independent domestic and international experts who are not affiliated with the research team. ? Responsibilities include:
assisting with the planning and implementation of the research protocol; receiving research progress reports on a regular basis; aiding in the resolution of research difficulties encountered; providing an independent assessment on a regular basis of the current status of research project

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Monitoring Group on Quality Control (MGQC)
? This committee is composed of Chinese and international experts and is in charge of maintaining the quality of data generated from this project. The main responsibility of this group is to supervise the quality of the study based on the overall aims and goals of the China CIPRA plan. They will oversee quality control in the following areas: epidemiology, laboratory techniques, experiment quality, clinical studies, and particular research related to the GCP standards. This group will also evaluate the appropriateness of the consent forms and any pertinent ethical issues. They will scrutinize and provide feedback to the researchers to assure the future quality of the research.

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Network of China-CIPRA Operational Systems
National Institutes of Health (NIH)

CIPRA Coordinating Committee (CCC)

CIPRA Executive Committee (CEC)

Scientific Advisory Board (SAB)

Study Plan/Protocol Ethic Committee (EC)

Study Implementation (Project and Core Activities) Community Advisory Board(CAB) Monitoring Group on Quality Control (MGQC)

Supervision Action

Inform

Study Population

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Summary of Progress
? ? ? ? ? Set up the administration structure and research team; Conducted preparation work at Shanxi local sites; Developed research protocols; Created SOPs for CIPRA team (on going); Organized training according to the plan;IRB, GCP, management, research techniques, etc. Some researchers were trained oversea ? Strengthened communication among projects and cores, and communication with international organizations. Created web site and newsletter (electronic/paper version).
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Training Information Welcome
? ? ? ? Project Management and Coordination Leadership and Organization 2 to 3 month/course advanced course preferred

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Contact information
Address: 4 Nan Wei Road, Room 510 Xuan Wu District Beijing, China 100050 Tel: 86-10-63045970; ; 63015577 ex. 6510 Fax: 86-10-63045970 E-mail: cipracn@public3.bta.net.cn Website: http://www.chinaids.org.cn/cipra

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