PHRU-Setshaba Clinical Trials Unit

PHRU-Setshaba 临床试验单位

• 批准号: 10057323
• 负责人: Glenda E Gray
• 金额: $ 353.3万
• 依托单位: WITS HEALTH CONSORTIUM (PTY), LTD
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10057323
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adherence; Adolescent; Adult; Age; Anti-Retroviral Agents; Child; Childhood; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Clinics and Hospitals; Collaborations; Communities; Development; Diagnosis; Disease remission; Drug Kinetics; Ensure; Epidemic; Ethics; Evaluation; Formulation; Funding; Gender; Generations; Geography; Goals; HIV; HIV Infections; HIV Vaccine Trials Network; HIV vaccine; HIV/TB; Health; Hepatitis B; Human; Human Milk; Immune; Immune response; Incidence; Infant; Infection; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Intervention; Investigation; Investments; Joints; Lead; Leadership; Medicine; Methods; Monoclonal Antibodies; Neurocognitive; Oral; Pathway interactions; Phase; Positioning Attribute; Pregnant Women; Prevalence; Prevention; Regimen; Research; Research Personnel; Research Support; Resistance; Role; STI prevention; Safety; Scientist; Social Behavior; South Africa; South African; Structure; Technology; Testing; Therapeutic; Therapeutic Clinical Trial; Time; Translating; Tuberculosis; Tuberculosis Vaccines; United Nations; United States National Institutes of Health; Vaccines; Vertical Disease Transmission; Woman; base; clinical development; clinical research site; comorbidity; drug-sensitive; high risk population; improved; innovation; neonate; novel; pediatric human immunodeficiency virus; pediatric human immunodeficiency virus infection; pre-exposure prophylaxis; pregnancy prevention; preservation; prevent; programs; racial and ethnic; racial diversity; side effect; transmission process; treatment as prevention; trial design; vaccination strategy; vaccine trial; young woman

PROJECT SUMMARY/ABSTRACT HIV is the epidemic of our time; South Africa is its epicenter. Current interventions are denting the epidemic but are unlikely to achieve the UNAIDS goal of ending HIV by 2030. In South Africa, new infections continue: in 2018, 240 000 new infections added to the 7.7 million South Africans living with HIV. South Africa has the largest ARV program in the world, but treatment as prevention has not stalled new infections. Although progress has been made in controlling pediatric HIV, we have yet to meet the Joint United Nations Programme on HIV/AIDS (UNAIDS) elimination targets. The significant TB burden amongst people living with HIV destabilizes TB control efforts. Taken together, these realities underscore the need to find effective biomedical interventions to prevent HIV, address the long-term management of HIV throughout the age spectrum, and investigate HIV remission. Ongoing research investment is vital to our attempt to achieve epidemic control. NIH-sponsored research has led to vital advances in both treatment and prevention. Our proposed PHRU- Setshaba Clinical Trials Unit (CTU), with seven Clinical Research Sites (CRS), is strategically positioned in high HIV prevalence and incidence geographic hotspots. Our access to informal settlements, maternity units, TB clinics and hospitals enables the CTU to investigate the prevention and control of HIV and TB. Our PHRU- Setshaba CTU has the long-term objective to support the scientific agenda of the four NIH HIV/AIDS Clinical Trials Networks to reduce the impact of HIV and TB on infants, children, adolescents and adults. Our CTU comprises of internationally renowned scientists, based in South Africa, predominantly women, from diverse racial and ethnic backgrounds, with a track record of capacity development. To contribute to the scientific agenda of the NIH HIV/AIDS Clinical Trials Networks, the CTU intends to: 1) evaluate novel active HIV vaccination strategies that may be efficacious by inducing non-neutralizing vaccine immune responses; 2) evaluate passive neutralization utilizing one or more monoclonal antibodies for biomedical prevention; 3) investigate the role of alternatives to oral pre-exposure prophylaxis such as long-acting antiretrovirals and multi-purpose prevention technologies; 4) assess HIV vaccines to prevent breastmilk transmission of HIV; 5) contribute to finding HIV treatment options that reduce long-term side-effects in both adults and children; 6) support research into HIV remission and 7) to contribute to the TB research agenda for TB prevention and therapeutics. We aim to achieve this by operating an efficient CTU that will oversee the execution of quality clinical research which is regulatory and ethically compliant, in partnership with our communities, as well as by developing a successor generation of diverse scientists.

项目概要/摘要 艾滋病毒是我们这个时代的流行病；南非是其震中。目前的干预措施正在遏制这种流行病，但 不太可能实现联合国艾滋病规划署到 2030 年消灭艾滋病毒的目标。在南非，新感染病例仍在继续： 2018 年，南非 770 万艾滋病毒感染者中新增了 24 万感染者。南非有 世界上最大的抗逆转录病毒计划，但治疗作为预防并没有阻止新的感染。虽然 在控制儿童艾滋病毒方面已取得进展，但我们尚未满足联合国联合规划署的要求 艾滋病毒/艾滋病（联合国艾滋病规划署）消除目标。艾滋病毒感染者面临巨大的结核病负担 破坏结核病控制工作的稳定性。总而言之，这些现实强调需要找到有效的生物医学方法 预防艾滋病毒的干预措施，解决整个年龄段艾滋病毒的长期管理，以及 研究艾滋病毒缓解情况。持续的研究投资对于我们控制疫情至关重要。 美国国立卫生研究院资助的研究在治疗和预防方面取得了重大进展。我们提议的 PHRU- Setshaba 临床试验中心 (CTU) 拥有七个临床研究中心 (CRS)，战略性地定位于 艾滋病毒流行率和发病率高的地理热点地区。我们可以进入非正规住区、产科单位、 结核病诊所和医院使 CTU 能够调查艾滋病毒和结核病的预防和控制情况。我们的 PHRU- Setshaba CTU 的长期目标是支持 NIH 四个 HIV/AIDS 临床研究的科学议程 减少艾滋病毒和结核病对婴儿、儿童、青少年和成人影响的试验网络。我们的货运单位 由来自南非的国际知名科学家组成，其中主要是女性，来自不同的领域 种族和族裔背景，具有能力发展的记录。为科学事业做出贡献 根据 NIH HIV/AIDS 临床试验网络的议程，CTU 打算：1) 评估新型活性 HIV 通过诱导非中和性疫苗免疫反应可能有效的疫苗接种策略； 2） 评估利用一种或多种单克隆抗体进行生物医学预防的被动中和作用； 3） 研究口服暴露前预防的替代方案的作用，例如长效抗逆转录病毒药物和 多用途预防技术； 4) 评估艾滋病毒疫苗以预防艾滋病毒母乳传播； 5） 有助于寻找减少成人和儿童长期副作用的艾滋病毒治疗方案； 6） 支持艾滋病毒缓解研究，7) 为结核病预防和结核病研究议程做出贡献 疗法。我们的目标是通过运营高效的 CTU 来监督质量执行情况来实现这一目标 与我们的社区合作以及通过遵守监管和道德规范的临床研究 培养下一代多样化的科学家。