JHU-MCAIDS HPTN TRIAL SITE-CHINA

JHU-MCAIDS HPTN 试用网站-中国

• 批准号: 6374590
• 负责人: Jay B Jackson
• 金额: $ 100.06万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-07-01 至 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6374590
• 关键词: AIDS; AIDS education /prevention; AIDS therapy; China; Chinese; HIV infections; antibiotics; clinical research; cooperative study; human immunodeficiency virus 1; human pregnant subject; human subject; human therapy evaluation; intravenous drug abuse; nevirapine; sex partner; vertical transmission; AIDS; AIDS education /prevention; AIDS therapy; China; Chinese; HIV infections; antibiotics; clinical research; cooperative study; human immunodeficiency virus 1; human pregnant subject; human subject; human therapy evaluation; intravenous drug abuse; nevirapine; sex partner; vertical transmission

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.

描述（改编自申请人的摘要）：HIV-1中的研究人员 约翰·霍普金斯大学（JHU）和国家的预防研究 预防与控制中心（NCAIDS），北京，中国建议 与HIV预防试验网络（HPTN）网站在北京建立 新疆和广西自治区域中进行HPTN试验的试验地点 在静脉吸毒者（IDU），他们的性伴侣和艾滋病毒感染者中 孕妇。 中国人民共和国（PRC）超过12亿 人们在这两个区域的HIV-1感染呈指数增长 至少有70％的艾滋病毒感染已知在IDU中，其中84％ 百分比是男性，女性为16％。 根据艾滋病毒的血清阳性 Ncaids于1999年进行的调查，目前有估计 中国有400,000名艾滋病毒感染者，预计将达到10 到2010年，百万。大约50％的IDU是HIV-1感染的 Xinjiang地区（亚型C/B'）和40％在广西地区（亚型C 和e）。 广西地区的血清染色IDU之间的血清含量率 1998年为12.1％。 大约有1.7％的孕妇是HIV- 在9/99中在几家医院进行的血清阳性调查中感染 新疆地区的乌罗姆奇市。 该项目具有3个具体目标。 （1）到 为了评估有希望的艾滋病毒，在中国建立HPTN网站 预防干预措施，重点是生物医学干预措施，例如 用于灭活针的洗涤剂，奈韦拉平的预防和/或 IDU人群及其性伴侣/婴儿中的微生物。 （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）进一步发展临床试验 基础设施并增强中国调查人员的专业/技能， 为了加强中国的艾滋病毒预防工作，学生和教职员工。 临床，数据管理，实验室和行政专业知识以及 在HIV-1中筛选，注册和保留高风险受试者所需的资源 干预试验将源自当前设施，人员， 以及现有JHU-NCAIDS研究合作的组织结构 使用中国的公共卫生网络系统。 指定的区域 该提案的兴趣和能力最初仅限于评估 IDU人群及其性伴侣/婴儿的生物医学干预措施。 但是，JHU-NCAIDS的合作确实在 疫苗和行为干预措施，并有可能采用这些疫苗 随着流行病的增长，IDU的干预措施或扩展到其他人群。