Aurum Clinical Trials Unit

Aurum 临床试验单位

• 批准号: 10528478
• 负责人: Gavin John Churchyard
• 金额: $ 131.96万
• 依托单位: AURUM INSTITUTE NPC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10528478
• 关键词: AIDS clinical trial group; AIDS prevention; Active Immunization; Address; Adherence; Adolescent; Adult; Africa; African; Anti-Retroviral Agents; Antibodies; Behavioral; Cardiovascular Diseases; Caring; Clinical Trials Unit; Collaborations; Communities; Complement; Complex; Couples; Data; Development; Diagnosis; Disease; Drug Combinations; Drug resistance in tuberculosis; Epidemic; Exposure to; Fishes; Funding; Future; Goals; HIV; HIV Antibodies; HIV Infections; HIV Vaccine Trials Network; HIV vaccine; HIV/TB; Health care facility; Home; Human immunodeficiency virus test; Incidence; Individual; Infection; Infrastructure; Infusion procedures; International; Intervention; Knowledge; Leadership; Maps; Participant; Patients; Persons; Pharmaceutical Preparations; Phase; Play; Population; Populations at Risk; Predisposition; Pregnancy; Prevention; Prevention Research; Prevention strategy; Prevention trial; Preventive therapy; Preventive vaccine; Primary Health Care; Principal Investigator; Recording of previous events; Recurrence; Regimen; Research; Research Personnel; Research Priority; Resistance; Risk; Role; Sexually Transmitted Diseases; Site; South Africa; Southern Africa; Structure; Sum; System; Technology; Testing; Therapeutic; Therapeutic Agents; Time; Tuberculosis; Tuberculosis Vaccines; Uganda; Vaccination; Vaccines; Zambia; antiretroviral therapy; clinical research site; combat; comorbidity; dashboard; epidemic response; experience; high risk; high risk men; high risk population; men; men who have sex with men; neglect; neutralizing antibody; novel; obesity prevention; pandemic disease; phase I trial; pre-exposure prophylaxis; prevent; preventive intervention; programs; recruit; sex; skills; social; study population; tool; transmission process; treatment strategy; treatment trial; tuberculosis drugs; tuberculosis treatment; unintended pregnancy; uptake; young woman

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.

项目总结 南部和东部非洲是世界54%的艾滋病毒携带者的家园，南部非洲仍然是 作为全球艾滋病毒大流行的震中。拟议的Aurum南非和东非临床试验股 (ASEA CTU)汇集了一个独特的南南伙伴关系，由三个国际公认的 研究人员，包括五个临床研究地点(三个在南非，一个在赞比亚，一个在#年 (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。ASEA CTU有一个强大的 集中化的管理结构，完善的CRSS，接触到所需的研究人群，以及 有进行艾滋病毒和结核病治疗和预防试验的经验。虽然在治疗方面取得了一些进展 为了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和结束 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、 与Three Network合作的经验和强大的社区关系，以实现以下目标：Aim 1：开展预防艾滋病毒的艾滋病毒疫苗和抗体试验。我们需要一种安全、有效的艾滋病毒疫苗 可大规模输送以对抗艾滋病毒；可通过被动输液或诱导产生抗体 通过接种疫苗将补充在可能接触艾滋病毒之前接受抗逆转录病毒治疗(ART)，以防止 感染艾滋病毒。目标2：进行艾滋病毒和结核病治疗试验，以及结核病预防治疗和 疫苗。为了结束结核病流行，我们需要更短、更有效的药物组合来治疗结核病。 对目前可用的结核病药物敏感或抗药性的疾病或感染，以及有效的疫苗 一旦接受治疗，就可以预防结核病的疾病或复发。尽管艾滋病毒的治疗取得了很大进展，但坚持 我们需要新的、安全的、简单的、有效的和持久的艺术形式。 这将促进吸收并解决遵守挑战。目标3：参与长篇小说研究 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遵守挑战 现有的预防方案。性传播感染(STI)和计划外怀孕的比率仍然存在 高，并强调需要能够同时预防艾滋病毒和其他情况的技术， 比如性传播感染和怀孕。