JHU-MCAIDS HPTN TRIAL SITE-CHINA

描述(改编自申请者摘要)：HIV-1研究人员 约翰·霍普金斯大学(JHU)和美国国立卫生研究院的预防研究 北京市艾滋病预防控制中心中国建议， 将在北京建立艾滋病毒预防试验网络(HPTN)网站 新疆和广西自治区试点开展HPTN试验 静脉吸毒者(IDU)、他们的性伴侣和艾滋病毒感染者 怀孕的女人。中华人民共和国中国(中华人民共和国)，人口超过12亿 在这两个地区，艾滋病毒-1感染人数呈指数级增长 已知至少70%的艾滋病毒感染是在注射吸毒者中，其中84 百分之十是男性，百分之十六是女性。根据HIV血清阳性率 NCAID在1999年进行的调查，目前估计有 中国艾滋病病毒感染者40万人，预计达到10人 到2010年将达到100万。年，约50%的注射吸毒者感染了HIV-1 新疆地区(C/B‘亚型)和广西地区(C亚型 和E)。年广西地区血清阴性静脉吸毒人群血清发病率调查 1998年为12.1%。大约1.7%的孕妇感染了艾滋病毒- 9/99在几家医院进行的血清阳性率调查中感染 新疆乌鲁木齐市。这个项目有3个具体目标。(1)至 在中国建立一个高PTN站点，用于评估有希望的艾滋病毒 预防干预措施，重点是生物医学干预措施，如 用于灭活针头的洗涤剂、奈韦拉平预防和/或 注射吸毒者及其性伴/婴儿中的杀微生物剂。(2)至 在开发/实施方面提供科学专业知识/领导 HPTN研究议程。(3)进一步开展临床试验 基础设施，提高中国调查人员的专业知识/技能， 为了加强中国在校学生和教职员工的艾滋病预防工作。 临床、数据管理、实验室和管理专业知识以及 筛选、登记和保留HIV-1高危对象所需的资源 干预试验将从现有的设施，人员， 和现有JHU-NCAID研究合作的组织结构 中国使用公共卫生网络系统。指定的区域 对该提案的兴趣和能力最初仅限于评估 注射吸毒者及其性伴/婴儿的生物医学干预。 然而，JHU-NCAID的合作确实在以下领域拥有专门知识 疫苗和行为干预，并可能使用这些 随着疫情的增长，对注射吸毒者的干预或扩大到其他人群。

DESCRIPTION (adapted from applicant's abstract): Investigators in HIV-1 prevention research from Johns Hopkins University (JHU) and the National Center for AIDS Prevention and Control (NCAIDS), Beijing, China propose that an HIV Prevention Trials Network (HPTN) site be established in Beijing with trial sites in Xinjiang and Guangxi autonomous regions to conduct HPTN trials among intravenous drug users (IDU), their sexual partners, and HIV-infected pregnant women. The People's Republic of China (PRC) with over 1.2 billion people has had an exponential increase in HIV-1 infection in these two regions with at least 70 percent of HIV infection known to be in IDUs, of which 84 percent are men and 16 percent are women. According to HIV seroprevalence surveys conducted in 1999 by the NCAIDS, there are currently an estimated 400,000 HIV-infected people in China with the number expected to reach 10 million by 2010. Approximately 50 percent of IDUs are HIV-1-infected in Xinjiang region (subtype C/B') and 40 percent in Guangxi region (subtypes C and E). The seroincidence rate among seronegative IDUs in Guangxi region in 1998 was 12.1 percent. Approximately, 1.7 percent of pregnant women were HIV- infected in 9/99 in a seroprevalence survey conducted in several hospitals in Uromqi City, Xinjiang region. This project has 3 specific aims. (1) To establish an HPTN site in China for the purpose of evaluating promising HIV prevention interventions with an emphasis on biomedical interventions such as detergent for inactivation of needles, nevirapine prophylaxis, and/or microbicides among IDU populations and their sexual partners/infants. (2) To provide scientific expertise/leadership in the development/implementation of the HPTN research agenda. (3) To further develop the clinical trials infrastructure and enhance the expertise/skills of Chinese investigators, students and staff in order to strengthen the HIV prevention efforts in China. The clinical, data management, laboratory, and administrative expertise and resources necessary to screen, enroll, and retain high-risk subjects in HIV-1 intervention trials will be derived from the current facilities, personnel, and organizational structure of the existing JHU-NCAIDS research collaboration using the public health network system in China. The specified area of interest and capability of this proposal is initially confined to evaluating biomedical interventions in IDU populations and their sexual partners/infants. However, the JHU-NCAIDS collaboration does have expertise in the areas of vaccines and behavioral interventions and could potentially employ these interventions in IDUs or expand to other populations as the epidemic grows.