Clinical Trial Unit for HIV Prevention and Microbicide Research

描述(由申请人提供)： 芬威社区卫生(FCH)是波士顿的一家社区卫生中心，从事艾滋病毒/艾滋病研究已有20多年，该中心建议建立一个临床试验股(基于其协调HIVNET和HPTN财团的经验)，该股已被邀请隶属于两个艾滋病毒/艾滋病临床试验领导小组：预防艾滋病毒(HPTN)和杀微生物剂(MTN)。FCH将监督CTU的行政部门，并将协调新英格兰东南部三个临床研究中心的活动，其中包括：FCH、拉丁美洲健康研究所(LHI，马萨诸塞州波士顿)和米里亚姆医院(TMH，普罗维登斯，RL)。CTU建议招募不同种族和民族的参与者参加以下方案：1.减少可卡因和兴奋剂使用者中艾滋病毒的血清发病率(N=250)；2.评估接触前预防艾滋病毒的新型抗逆转录病毒药物的有效性(250)；3.用丁丙诺啡降低静脉注射吸毒者的艾滋病毒发病率(150)；4.评估和制定针对急性感染艾滋病毒的个人的干预措施(100)；5.招募高危妇女参加杀微生物剂准备研究(100)；6.评估口服与外用替诺福韦(20)；6.评估一种新型杀微生物剂(20)；7.在第二阶段研究中将新的杀微生物剂与安慰剂凝胶进行比较(40)；8.将高危妇女纳入第三阶段研究(200)；9.将最近感染的试验参与者纳入观察性研究(超过90%的新感染患者)。所有三个CRS都在HPTN中合作，招募了不同的高危人群和艾滋病毒感染者，FCH重点关注MSM，LHI关注拉丁裔，TMH关注女性。目前的建议表明，每个CRS都有能力增加和多样化其招募相关人群参加这些试验的能力。每个CRS都有进行有效和道德试验所需的基础设施，包括训练有素、符合GCP的工作人员；临床和实验室资源、数据收集、传输和分析方面的经验；具有FWA的IRBs；独立的社区咨询委员会。CTU和参与的CRS的领导层在USPHS资助的多个研究方案上进行了合作，并在这项提案中展示了优化合作调查人员互补优势的机制，包括与不同人群合作的经验，最大限度地提高资源利用效率的计划，以及对新调查人员的指导。 管理组件：

DESCRIPTION (provided by applicant): Fenway Community Health (FCH), a Boston community-health center, which has conducted HIV/AIDS research for more than two decades, proposes to establish a Clinical Trials Unit (based on its experience coordinating HIVNET and HPTN consortia), which has been invited to be affiliated with two HIV/AIDS Clinical Trial Leadership Groups: Prevention of HIV (HPTN) and Microbicides (MTN). FCH will oversee the Administrative Component of the CTU and will coordinate the activities of three Clinical Research Sites in southeastern New England including: FCH, Latin American Health Institute (LHI, Boston, MA) and The Miriam Hospital (TMH, Providence, Rl). The CTU proposes to enroll a racially and ethnically diverse cohort of participants in the following protocols: 1. to reduce HIV seroincidence in cocaine and stimulant users (N=250); 2. to assess the efficacy of novel antiretrovirals for pre-exposure prophylaxis to prevent HIV transmission (250); 3. to decrease HIV incidence in IDU with buprenorphine (150); 4. to assess and develop interventions for individuals acutely infected with HIV (100); 5. to enroll high risk women in microbicide preparedness studies (100); 6. to assess oral versus topical tenofovir (20); 6. to evaluate a novel microbicide (20); 7. to compare a new microbicide with a placebo gel in a Phase II study (40); 8. to enroll high risk women in a Phase III study (200); 9. to enroll recently infected trial participants into observational studies (over 90% of newly infected patients). All 3 CRSs have worked together in the HPTN, enrolling distinctive populations of at risk and HIV-infected people, with FCH focusing on MSM, LHI on Latinos, and TMH on women. The current proposal demonstrates the ability of each CRS to increase and diversify its ability to enroll relevant populations for these trials. Each CRS has the infrastructure necessary for the conduct of effective and ethical trials, including well-trained, GCP-compliant staff; clinical and laboratory resources, experience with data collection, transmittal, and analysis; IRBs with FWAs; independent community advisory boards. The leadership of the CTU and participating CRS has worked together on multiple USPHS -funded research protocols, and demonstrate in this proposal the mechanisms to optimize the complementary strengths of the collaborative investigators, including experience working with diverse populations, plans for maximal efficiency in resource utilization, and mentoring of new investigators. ADMINISTRATIVE COMPONENT: