Aurum Clinical Trials Unit

项目摘要 南部和东部非洲是世界上54%的艾滋病毒感染者的家园，南部非洲仍然是 是全球艾滋病流行的中心拟议的Aurum南部和东部非洲临床试验部门 (ASEA CTU）汇集了由三个国际公认的 研究者，包括五个临床研究中心（CRS）（三个在南非，一个在赞比亚，一个在南非）。 乌干达）在开展艾滋病毒和结核病治疗和预防试验方面经验丰富。东盟反恐组有一个强大的 集中的管理结构，完善的CRS，获得所需的研究人群，以及 开展艾滋病毒和结核病治疗和预防试验的经验。虽然在治疗癌症方面 以及预防艾滋病毒和结核病，我们需要开发新的治疗和预防工具来控制艾滋病毒， 结核病流行。ASEA CTU的主要目标是利用其集体科学领导，基础设施， 经验和强大的社区关系，与三个网络合作，以实现以下目标：AIM 1.进行艾滋病毒疫苗和抗体的试验，以预防艾滋病毒。我们需要一种安全有效的艾滋病毒疫苗， 可以大规模提供以对抗艾滋病毒;可以通过被动输注或诱导 接种疫苗将补充在可能的艾滋病毒暴露之前接受抗逆转录病毒治疗（ART）， 感染艾滋病病毒。目标2：开展艾滋病毒和结核病治疗试验，以及结核病预防性治疗试验， 疫苗。为了结束结核病的流行，我们需要更短、更有效的药物组合来治疗结核病 对现有结核病药物敏感或耐药的疾病或感染，以及有效的疫苗， 预防结核病或结核病复发。尽管艾滋病毒治疗取得了巨大进展， 我们需要新的、安全的、简单的、有效的和持久的ART形式， 这将促进吸收和应对遵守方面的挑战。目的3：参与新型长效药物的研究 抗逆转录病毒药物、多用途技术和艾滋病毒预防综合战略。我们的经验表明 需要更有针对性和个性化的干预措施来克服依从性挑战， 现有的预防措施。性传播感染和意外怀孕的比率仍然很高， 高，并强调需要能够同时预防艾滋病毒和其他疾病的技术， 例如性传播感染和怀孕。

PROJECT SUMMARY Southern and East Africa is home to 54% of the world’s people living with HIV, with Southern Africa remaining as the epicenter of the global HIV pandemic. The proposed Aurum South and East African Clinical Trials Unit (ASEA CTU) brings together a unique South–South partnership led by three internationally recognized investigators and including five clinical research sites (CRSs) (three in South Africa, one in Zambia, and one in Uganda) experienced in conducting HIV and TB treatment and prevention trials. The ASEA CTU has a strong centralized management structure, well-developed CRSs, access to the required study populations, and experience conducting HIV and TB treatment and prevention trials. While there have been advances in treating and preventing HIV and TB, we need to develop new treatment and prevention tools to control HIV and end the TB epidemic. The ASEA CTU’s primary goal is to use its collective scientific leadership, infrastructure, experience, and strong community relationships to partner with three Networks to meet the following aims: AIM 1: Conduct trials of HIV vaccines and antibodies for HIV prevention. We need a safe, effective HIV vaccine that can be delivered at scale to combat HIV; antibodies that could be delivered through passive infusion or induced by vaccination would complement taking antiretroviral therapy (ART) before possible HIV exposure to prevent becoming infected with HIV. AIM 2: Conduct trials of HIV and TB therapeutics, and TB preventive therapy and vaccines. In order to end the TB epidemic, we need shorter, more potent combinations of drugs to treat TB disease or infection that is susceptible or resistant to the currently available TB drugs, and effective vaccines to prevent disease or re-occurrence of TB once treated. Despite great advances in the treatment of HIV, adherence to and retention in care remain problems; we need new, safe, simple, effective, and long-lasting forms of ART that will promote uptake and address adherence challenges. AIM 3: Participate in studies of novel long acting antiretrovirals, multipurpose technologies, and integrated strategies for HIV prevention. Our experience suggests that more targeted and individually tailored interventions are required to overcome adherence challenges with existing prevention options. Rates of sexually transmitted infections (STIs) and unplanned pregnancy remain high and underscores the need for technologies that can prevent HIV and other conditions at the same time, such as STIs and pregnancy.