Clinical Trial Unit for HIV Prevention and Microbicide Research

描述（由申请人提供）： 芬威社区健康（FCH），波士顿社区卫生中心，进行了二十多年的艾滋病毒/艾滋病研究，建议建立一个临床试验单位（根据其协调HIVNET和HPTN财团的经验），已被邀请加入两个艾滋病毒/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的三个临床研究中心的活动，包括：FCH、拉丁美洲卫生研究所（LHI，Boston，MA）和Miriam医院（TMH，普罗维登斯，RI）。CTU建议在以下方案中招募种族和民族多样化的参与者队列：1.降低可卡因和兴奋剂使用者中的HIV血清发生率（N=250）; 2.评估新型抗逆转录病毒药物用于暴露前预防以预防HIV传播的有效性（250）; 3.使用丁丙诺啡降低IDU中的HIV发病率（150）; 4.评估和制定针对艾滋病毒急性感染者的干预措施（100）; 5.让高危妇女参加杀微生物剂准备研究（100）; 6.评估口服与局部替诺福韦（20）; 6.评价新型杀微生物剂（20）; 7.在II期研究中比较新的杀微生物剂与安慰剂凝胶（40）; 8.在III期研究中招募高风险女性（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3个社区服务中心都在HPTN中合作，招收不同的高危人群和艾滋病毒感染者，FCH侧重于男男性行为者，LHI侧重于拉丁美洲人，TMH侧重于妇女。目前的提案证明了每个CRS增加和多样化其招募这些试验相关人群的能力。每个CRS都有进行有效和符合伦理的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、传输和分析的经验;具有FWA的IRB;独立的社区咨询委员会。CTU的领导层和参与的CRS已经在多个USPHS资助的研究方案上进行了合作，并在本提案中展示了优化合作研究者互补优势的机制，包括与不同人群合作的经验，资源利用效率最大化的计划，以及对新研究者的指导。 行政部门：

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: