Botswana-Harvard School of Public Health AIDS Initiative Partnership CTU

博茨瓦纳-哈佛大学公共卫生学院艾滋病倡议伙伴关系 CTU

• 批准号: 7346977
• 负责人: MYRON E ESSEX
• 金额: $ 231.84万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7346977
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Adult; Area; Award; Botswana; Category Rating Scale; Clinical; Clinical Trials; Community Relations; Enrollment; Ethical Review; Government; HIV vaccine; Head; Informed Consent; International Maternal Pediatric Adolescent AIDS Clinical Trials Group; Leadership; Numbers; Phase; Phase II/III Trial; Population; Prevention; Prevention Research; Procedures; Public Health Schools; Research; Resources; Site; Vaccine Therapy; Vaccines; base; clinical research site; organizational structure; programs; treatment trial; volunteer

DESCRIPTION (provided by applicant): This proposal is to establish an AIDS research Clinical Trials Unit (CTU) at the Botswana-Harvard School of Public Health AIDS Initiative Partnership (BHP) in Botswana. The CTU would conduct a fully integrated program for conducting AIDS clinical trials in three programmatic areas: vaccines, therapy, and prevention research. These areas of emphasis would coincide with trials conducted by the HIV Vaccine Trials Network (HVTN), the Adult AIDS Clinical Trials Group (AACTG), and the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT). Trials are already conducted at BHP under the auspices of HVTN and AACTG. The Botswana CTU would include three Clinical Research Sites (CRSs). These would be: (1) the Gaborone-based HIV Vaccine Trial Unit (HVTU) CRS; (2) the Gaborone-based Prevention and Treatment Trial (PTT) CRS, which would do both prevention (IMPAACT) and treatment (AACTG) trials; and (3) the Molepolole-based Prevention and Treatment Trial (PTT) CRS which would also do both prevention (IMPAACT) and treatment (AACTG) trials. This organizational structure is designated as such because vaccine trials would be done only in Gaborone, and the HVTU CRS facility is separate from the PTT CRS facility in Gaborone. The combined resources of the BHP have major expertise in clinical trial research, extensive facilities, and a large and diversified population of potential volunteers for the conduct of Phase I, Phase II, and Phase III trials. We plan to enroll at least 20 subjects in each of the three sites for each respective area of emphasis during the first six months of the award, and have already enrolled much larger numbers on an annual basis in all three areas. Procedures to assure ethical review, clinical oversight, informed consent, government and institutional approvals, and community relations are described. The proposed PI for the CTU, Dr. M. Essex, and the proposed heads for the three CRSs, Drs. T. Villafana, I. Thior, and W. Wester would provide both intellectual and administrative leadership. ADMINISTRATIVE COMPONENT:

描述(由申请人提供)： 这项提议是在博茨瓦纳-哈佛公共卫生学院艾滋病倡议伙伴关系(BHP)下建立一个艾滋病研究临床试验股(CTU)。CTU将在三个规划领域进行艾滋病临床试验的完全整合的计划：疫苗、治疗和预防研究。这些重点领域将与艾滋病毒疫苗试验网络(HVTN)、成人艾滋病临床试验小组(AACTG)和国际母婴青少年艾滋病临床试验小组(IMPAACT)进行的试验相吻合。必和必拓已经在HVTN和AACTG的主持下进行了试验。 博茨瓦纳CTU将包括三个临床研究站点(CRSS)。这些将是：(1)哈博罗内艾滋病毒疫苗试验股(HVTU)CRS；(2)哈博罗内预防和治疗试验(PTT)CRS，它将进行预防(IMPAACT)和治疗(AACTG)试验；以及(3)基于Molepolole的预防和治疗试验(PTT)CRS，它也将进行预防(IMPAACT)和治疗(ACTG)试验。之所以指定这样的组织结构，是因为疫苗试验将只在哈博罗内进行，而HVTU CRS设施与哈博罗内的PTT CRS设施是分开的。 必和必拓的联合资源拥有临床试验研究方面的主要专业知识、广泛的设施，以及进行第一阶段、第二阶段和第三阶段试验的大量和多样化的潜在志愿者群体。我们计划在奖项的前六个月内，为每个重点领域分别在三个地点各招收至少20名科目，并已在所有三个领域每年招收更多的科目。描述了确保伦理审查、临床监督、知情同意、政府和机构批准以及社区关系的程序。CTU的拟议PI M.Essex博士和三个CRSS的拟议负责人T.Villafana博士、I.Thior博士和W.Wester将提供智力和行政领导。 管理组件：