HIV PREVENTION TRIAL UNIT (HPTU)-PUNE, INDIA

HIV 预防试验中心 (HPTU) - 印度浦那

• 批准号: 7094637
• 负责人: ROBERT C. BOLLINGER
• 金额: $ 205.33万
• 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 2009-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7094637
• 关键词: AIDS; AIDS education /prevention; AIDS therapy; HIV infections; India; antiAIDS agent; antibiotics; behavior therapy; behavioral /social science research tag; clinical research; clinical trial phase I; cooperative study; human immunodeficiency virus 1; human subject; human therapy evaluation; medical outreach /case finding; prostitution; sex partner; sexually transmitted diseases; southeast Asian

This application proposes a project site in Pune, India, as a clinical trials unit to join the HIV Prevention Trials Network (HPTN) with the following four specific aims: 1. To conduct multiple Phase I, II and m clinical trials of interventions designed to prevent HIV infection. 2. To identity and address social, behavioral and logistical barriers to screening, enrollment and retention of participants for clinical trials to prevent HIV infection. 3. To identity additional potential cohorts for HPTN trials in India. 4. To participate in collaborative studies within the HPTN to facilitate the development, design and implementation of strategies to prevent "IV infection. This collaborative proposal including investigators at the National AIDS Research Institute (NARI) in Pune, India and the Johns Hopkins University (JHU) has been proposed for the following reasons: A) The success of a 7-year HIV research collaboration between NAM and JHU B) An established and experienced, local Ethical Review Board and Community Advisory Board C) Completion of three Phase I clinical trials, in cohorts of individuals at both high and low risk for HIV, including two multi-national collaborative HIVNET clinical trials. D) Follow-up rates of greater than 92%for three recent HIV clinical trials and 2 prospective cohort studies of individuals at both high- and low-risk for HIV infection. E) An established cohort of more than 2500 high-risk male and female individuals with an annual HIV incidence of 6.4%/100 person years. We have demonstrated the ability to identity, enroll and follow low-risk women, high-risk men, female sex workers, married women at risk for HIV and discordant couples, appropriate for multiple Phase I, II and III HIV prevention clinical trials. Our site is capable of undertaking clinical trials of a variety of potential HIV prevention interventions, including microbicides, barrier methods, behavioral interventions, STD control and post-exposure prophylaxis. We will also apply novel approaches for estimating HIV incidence in other targeted populations for potential HPTU expansion in Pune. We will also undertake a comprehensive behavioral science research agenda to increase community HIV prevention education, to assess the willingness of our populations to participate in HPTN trials, and to ensure adequate the follow-up and retention for HPTN trials. In light of many years of productive collaboration and our prior experience with multinational collaborative clinical trials of HIV prevention strategies, we believe our project site in Pune, India is uniquely experienced and qualified to participate in the HPTN.

本申请建议在印度浦那设立一个项目地点，作为临床试验单位加入艾滋病毒预防试验网络(HPTN)，具体目标如下：1.进行旨在预防艾滋病毒感染的干预措施的多个I、II和M阶段临床试验。2.查明和解决筛查、招募和留住参加预防艾滋病毒感染的临床试验参与者的社会、行为和后勤障碍。3.确定在印度进行HPTN试验的其他潜在队列。4.参与HPTN内的合作研究，以促进制定、设计和实施预防“IV感染”的战略。提出这项合作建议时，有印度浦那国家艾滋病研究所(Nari)和约翰霍普金斯大学(JHU)的研究人员参与，原因如下：a)不结盟运动和约翰霍普金斯大学之间为期7年的艾滋病毒研究合作取得成功；b)建立了一个成熟而有经验的地方伦理审查委员会和社区咨询委员会；c)完成了三项I期临床试验，对艾滋病毒的高风险和低风险个人进行了分组试验，其中包括两项跨国合作的HIVNET临床试验。D)最近的三项艾滋病毒临床试验和两项前瞻性队列研究的随访率超过92%，这些研究涉及艾滋病毒感染的高风险和低风险个人。E)建立了2500多名艾滋病毒年发病率为6.4%/100人年的高危男性和女性的队列。我们已经展示了识别、登记和跟踪低风险妇女、高危男子、女性性工作者、有艾滋病毒风险的已婚妇女和不和谐的夫妇的能力，适用于多个第一、第二和第三阶段艾滋病毒预防临床试验。我们的网站能够进行各种潜在艾滋病毒预防干预措施的临床试验，包括杀菌剂、屏障方法、行为干预、性病控制和暴露后预防。我们还将应用新的方法来估计其他目标人群的艾滋病毒发病率，以便在浦那扩大HPTU的潜在规模。我们还将开展一项全面的行为科学研究议程，以加强社区艾滋病毒预防教育，评估我们的人群参与HPTN试验的意愿，并确保对HPTN试验进行足够的跟踪和保留。鉴于我们多年的卓有成效的合作以及我们在艾滋病毒预防策略的多国合作临床试验方面的先前经验，我们相信我们位于印度浦那的项目地点具有独特的经验和资格参与HPTN。