Botswana-Harvard School of Public Health AIDS Initiative Partnership CTU

描述（由申请人提供）： 这项建议是在博茨瓦纳的博茨瓦纳-哈佛大学公共卫生学院艾滋病倡议伙伴关系（BHP）中建立一个艾滋病研究临床试验单位（CTU）。CTU将在疫苗、治疗和预防研究三个项目领域开展艾滋病临床试验的全面综合计划。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组（AACTG）和国际孕产妇儿童青少年艾滋病临床试验组（IMPAACT）进行的试验相吻合。在HVTN和AACTG的主持下，必和必拓已经进行了试验。 博茨瓦纳CTU将包括三个临床研究中心（CRS）。这将是：（1）基于哈博罗内的艾滋病毒疫苗试验单位（HVTU）CRS;（2）基于哈博罗内的预防和治疗试验（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，也将进行预防（IMPAACT）和治疗（AACTG）试验。之所以指定这种组织结构，是因为疫苗试验只在哈博罗内进行，HVTU CRS设施与哈博罗内的PTT CRS设施分开。 必和必拓的综合资源在临床试验研究、广泛的设施和大量多样化的潜在志愿者群体方面具有重要的专业知识，可用于开展I期、II期和III期试验。我们计划在该奖项的前六个月内，在三个地点中的每个地点为每个重点领域招募至少20名受试者，并且已经在所有三个领域每年招募了更多的受试者。程序，以确保伦理审查，临床监督，知情同意，政府和机构的批准，和社区关系的描述。CTU的首席研究员M博士埃塞克斯，以及三个CRS的拟议负责人，T。比利亚法纳岛Thior和W.韦斯特将提供智力和行政领导。 行政部门：

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: