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

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（改编自申请人摘要）：HIV-1研究者 约翰霍普金斯大学（JHU）和美国国家卫生研究院的预防研究 中国北京艾滋病预防控制中心建议， 在北京建立艾滋病预防试验网络（HPTN）， 新疆和广西自治区的试验中心进行HPTN试验 静脉注射毒品使用者（IDU），他们的性伴侣和艾滋病毒感染者 孕妇 中华人民共和国拥有超过12亿人口 在这两个地区， 已知至少70%的艾滋病毒感染者是注射吸毒者，其中84 男性占16%，女性占16%。 根据艾滋病毒血清阳性率 根据1999年NCAIDS进行的调查， 中国艾滋病病毒感染者40万人预计将达10人 到2010年，亿。 大约50%的注射吸毒者是艾滋病毒-1感染者， 新疆地区（C/B '亚型）和广西地区（C亚型）各占40 和E）。 年广西地区静脉吸毒人群血清学阴性者的发病率 1998年为12.1%。 大约1.7%的孕妇感染了艾滋病毒， 在1999年9月在几家医院进行的血清阳性率调查中， 新疆乌鲁木齐市。 该项目有三个具体目标。 (1)到 在中国建立一个HPTN研究中心，以评估有希望的HIV 预防干预措施，重点是生物医学干预措施， 灭活去污剂 奈韦拉平 预防和/或 在注射吸毒者及其性伴侣/婴儿中使用杀微生物剂。 (2)到 在制定/实施方面提供科学专门知识/领导 HPTN研究议程。 (3)为了进一步开展临床试验 加强基础设施，提高中国调查人员的专业知识/技能， 学生和工作人员，以加强在中国的艾滋病预防工作。 临床、数据管理、实验室和管理专业知识， 筛选、入组和保留HIV-1高风险受试者所需的资源 干预试验将来自现有的设施，人员， 现有JHU-NCAIDS研究合作的组织结构 利用中国的公共卫生网络系统。 的指定区域 本提案的兴趣和能力最初仅限于评估 对注射吸毒者及其性伴侣/婴儿采取生物医学干预措施。 然而，JHU-NCAIDS合作在以下领域拥有专门知识： 疫苗和行为干预，并可能利用这些 在注射吸毒者中采取干预措施，或随着流行病的发展扩大到其他人群。