Botswana-Harvard School of Public Health AIDS Initiative Partnership CTU

描述(由申请人提供)： 这项提议是在博茨瓦纳-哈佛大学建立一个艾滋病研究临床试验股(CTU) 博茨瓦纳公共卫生学院艾滋病倡议伙伴关系(BHP)。CTU将进行一次全面的 在三个方案领域进行艾滋病临床试验的综合方案：疫苗、治疗、 和预防研究。这些重点领域将与艾滋病病毒进行的试验相吻合 疫苗试验网络(HVTN)、成人艾滋病临床试验小组(AACTG)和国际 孕产妇青少年艾滋病临床试验小组(IMPAACT)。试验已经在以下地点进行 必和必拓在HVTN和AACTG的赞助下。 博茨瓦纳CTU将包括三个临床研究站点(CRSS)。这些措施包括：(1) 基于哈博罗内的艾滋病毒疫苗试验单位(HVTU)CRS； 治疗试验(PTT)CRS，将进行预防(IMPAACT)和治疗(AACTG)试验； 和(3)基于Molepolole的预防和治疗试验(PTT)CRS，它也将同时完成这两项工作 预防(IMPAACT)和治疗(AACTG)试验。该组织结构被指定为 这是因为疫苗试验将只在哈博罗内进行，而HVTU CRS设施是单独的 来自哈博罗内的PTT CRS设施。 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， 以及大量和多样化的潜在志愿者群体，以进行第一阶段、第二阶段和 第三阶段试验。我们计划在三个地点的每个地区招收至少20名科目 在奖项的前六个月是重点，并且已经招收了更多的人 在所有三个领域每年都是如此。确保伦理审查、临床监督、知情的程序 对同意、政府和机构批准以及社区关系进行了描述。建议数 反恐小组的PI M.Essex博士和三个CRSS的拟议负责人T.Villafana博士，I.Thior博士， 而W·韦斯特将同时提供智力和行政领导。

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.