Clinical Trial Unit for HIV Prevention and Microbicide Research

空间 但前提是。 芬威社区卫生(FCH)，波士顿的一家社区卫生中心，它已经进行了艾滋病毒/艾滋病 经过二十多年的研究，建议建立一个临床试验股(根据其经验 协调HIVNET和HPTN财团)，该财团已被邀请隶属于两个艾滋病毒/艾滋病诊所 试验领导小组：预防艾滋病毒(HPTN)和杀微生物剂(MTN)。食环署署长将负责监督 CTU的行政部门，并将协调三个临床研究站点在#年的活动 新英格兰东南部包括：FCH、拉丁美洲健康研究所(LHI，波士顿，马萨诸塞州)和 米里亚姆医院(TMH，普罗维登斯，RL)。CTU提议招收一个种族和民族多元化的队列 参与下列方案的参与者：1.减少可卡因和兴奋剂使用者的艾滋病毒血清发病率 (n=250)；2.评估新的抗逆转录病毒药物在暴露前预防艾滋病毒的效果 传播(250)；3.用丁丙诺啡降低注射吸毒者的艾滋病毒发病率(150)；4.评估和发展 对艾滋病毒急性感染者的干预措施(100)；5.招募高危妇女参加杀微生物剂 准备研究(100)；6.评价口服与外用替诺福韦(20)；6.评价一种新型杀微生物剂 (20)；7.在第二阶段研究中比较新的杀微生物剂和安慰剂凝胶(40)；8.登记高危人群 妇女参与第三阶段研究(200)；9.将最近感染病毒的试验参与者纳入观察性研究 (超过90%的新感染病例)。所有3个CRS都在HPTN中共同工作，注册了与众不同的 高危人群和艾滋病毒感染者，FCH侧重于MSM，LHI侧重于拉丁裔，TMH侧重于 女人。目前的提案表明，每个CRS都有能力增加其能力并使其多样化 招募相关人群参加这些试验。每个CRS都有执行以下操作所需的基础设施 有效和合乎道德的试验，包括训练有素、符合GCP的工作人员；临床和实验室资源； 在数据收集、传输和分析方面有经验；IRB与FWA；独立社区 顾问委员会。CTU的领导层和参与的CRS在多个方面进行了合作 USPHS资助的研究方案，并在该提案中展示了优化 协作调查人员的优势互补，包括与不同的 人口，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。

SPACE PROVIDED. 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 antiretroviralsfor 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 pts). All 3 CRS 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 laboratoryresources, experience with data collection, transmittal, and analysis; IRB's with FWA's; independent community advisory boards. The leadership of the CTU and participating CRS have 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.