Aurum Clinical Trials Unit

Aurum 临床试验单位

基本信息

批准号：
10305671
负责人：
Gavin John Churchyard
金额：
$ 125.87万
依托单位：
AURUM INSTITUTE NPC
依托单位国家：
美国
项目类别：
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/10305671
关键词：
AIDS clinical trial group AIDS prevention Active Immunization Address Adherence Adolescent Adult Africa African Anti-Retroviral Agents 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 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 base clinical research site combat comorbidity dashboard 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 response sex skills social structure study population tool transmission process treatment strategy treatment trial tuberculosis drugs tuberculosis treatment unintended pregnancy uptake young woman

项目摘要

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.

项目概要南部非洲和东非居住着世界上 54% 的艾滋病毒感染者，其中南部非洲仍然拟议的 Aurum 南非和东非临床试验中心。 (ASEA CTU) 汇集了由三个国际公认的机构领导的独特的南南伙伴关系研究人员，包括 5 个临床研究中心 (CRS)（3 个在南非、1 个在赞比亚、1 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，ASEA CTU 拥有强大的实力。集中管理结构、完善的 CRS、接触所需研究人群的机会，以及进行艾滋病毒和结核病治疗和预防试验的经验，同时在治疗方面取得了进展。和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并结束 ASEA CTU 的主要目标是利用其集体科学领导力、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预防艾滋病毒的试验我们需要一种安全、有效的艾滋病毒疫苗。可以大规模输送以对抗艾滋病毒，可以通过被动输注或诱导输送抗体；通过疫苗接种可以补充在可能接触艾滋病毒之前采取抗逆转录病毒治疗（ART），以预防目标 2：进行艾滋病毒和结核病治疗以及结核病预防治疗的试验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。对目前可用的结核病药物敏感或耐药的疾病或感染，以及有效的疫苗尽管在治疗艾滋病毒方面取得了很大进展，但仍需坚持治疗，以预防疾病或结核病复发。护理的获得和保留仍然是问题；我们需要新的、安全的、简单的、有效的和持久的抗逆转录病毒疗法目标 3：参与新型长效药物的研究。我们的经验表明，抗逆转录病毒药物、多用途技术和艾滋病毒预防综合策略。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方案仍然存在，性传播感染（STI）和意外怀孕的发生率仍然存在。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。