IMPAACT RELATED PROTOCOLS FOR THE RESEARCH ON TREATMENT, PREVENTION, DIAGNOSIS AND EPIDEMIOLOGY OF HIV INFECTIONS

HIV 感染的治疗、预防、诊断和流行病学研究的影响相关方案

• 批准号: 10369859
• 负责人: BARBARA DRIVER
• 金额: $ 248.67万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10369859
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Adolescent; Aftercare; Anti-Retroviral Agents; Area; Child; Childhood; Clinical Protocols; Clinical Trials; Collaborations; Communicable Diseases; Communities; Conduct Clinical Trials; Data; Data Analyses; Development; Diagnosis; Disease remission; Epidemic; Epidemiology; Formulation; Goals; HIV; HIV Infections; HIV therapy; Individual; Infant; Infection; Institution; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Intervention; Knowledge; Leadership; Light; Monitor; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; Nature; Opportunistic Infections; Passive Immunotherapy; Pharmaceutical Preparations; Population; Postpartum Women; Pregnant Women; Prevention; Prevention approach; Process; Protocols documentation; Reporting; Research; Research Personnel; Research Priority; Resources; Science; Site; Symptoms; Testing; Therapeutic Agents; Time; Vaccines; Vertical Disease Transmission; Work; antiretroviral therapy; base; clinical center; co-infection; comorbidity; infection rate; patient population; perinatal HIV; pregnant; prevent; recruit; synergism; targeted treatment; transmission process; young woman

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) provides clinical trial sites to the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT). The IMPAACT network and its leadership group oversee the creation of all their studies, protocols, and clinical trials. The IMPAACT Network is a cooperative group of institutions, investigators, and other collaborators mainly focused on evaluating potential therapies for HIV infection and its related symptoms and co-infections in infants, children, adolescents and pregnant women. This includes clinical trials of HIV/AIDS interventions for the prevention of mother to child transmission. The IMPAACT Network goal is to conduct high quality clinical trials and/or protocols that will advance the prevention and treatment of HIV and its complications for infants, children, adolescents, and pregnant/ postpartum women globally. The IMPAACT research agenda in this task order includes four scientific specific aims, which reflect the key areas of work. Those areas are HIV Treatment, HIV Prevention, HIV Cure, and HIV Complications. For each area, a Scientific Committee composed of experts in the specific field, site investigators, community representatives, and representatives of the central network resources, continually reassesses the research priorities in light of emerging science as well as new ideas and opportunities; it seeks collaboration with other trials networks and research entities; oversees the formulation and review of study concept plans based on the scientific priorities; and monitors the development and implementation of approved network studies in the specific research area. In 1990 the NICHD began collaborating with the Pediatric AIDS Clinical Trials Group (PACTG) to expand clinical trial availability at NICHD clinical trial centers/sites. This collaboration made possible to conduct clinical trials by the IMPAACT Network to further evaluate antiretroviral therapeutic agents, other therapies targeted at opportunistic infections, and interventions to prevent perinatal HIV transmission. In recent years, the collaboration is expanding to evaluate potential HIV cure approaches and vaccines. The purpose of this task order is to recruit, follow and complete the IMPAACT Related protocols listed below. The integration of the results of these 2 protocols, which will be presented in a final report, will provide data to advance the prevention, treatment and remission of HIV, its most common complications and related infectious diseases in maternal, adolescent and pediatric populations. For the last 35 years NICHD/NIAID as part of the scientific community have been conducting intense HIV research. During this time, it became clear that to be successful in the attempt to curve the HIV infection rates of the epidemic, and appropriately treat the individual infectious process, an integrated and comprehensive approach to HIV research is required. Furthermore, NICHD/NIAID and others in the scientific community found in the mid-90s that one or even two different anti-retroviral drugs (ARVs) are not sufficient to appropriately treat an individual HIV infection. Therefore, the synergy of three or more drugs (ARVs) is required to effectively treat and keep at bay an individual HIV infection. For that reason, the development and testing of multiple ARVs in different trials is essential. This requires the development and testing of multiple ARVs in different trials. At the same time, as soon as a drug was developed and approved, multiple other trials were needed to discern the potential synergy between them. It is now known to the scientific community, that the initial attempts to achieve an HIV Cure (remission) might require the interaction of multiple ARVs, in addition to an early start in the treatment after infection (clinical protocols in this task order) plus the potential use of passive immunotherapy plus long term acting antiretroviral therapy (under study in a task order protocol) and possibly even therapeuticvaccines. DocuSign Envelope ID: B345E7A5-BACD-4AAE-9195-449332381126 2 Therefore, it is evident that although all individual trials (protocols) can provide very useful information, the integration of this acquired knowledge from some of the different protocols will provide a more comprehensive data analysis that will lead to a better scientific assessment to determine the best approach for prevention and treatment of HIV and its complications and comorbidities in the maternal, adolescent and pediatric populations. While the individual protocols are important, completion of the 2 protocols in this task order and receipt of the final report, which includes the integrated data from these protocols, is necessary because if not NICHD and the IMPAACT Network may lose part of the comprehensive nature of these studies. It is also evident that combined results could eventually help in the process of achieving a better and sustained HIV remission, and a more effective prevention and treatment for HIV and other related infectious diseases in pediatric, adolescent, and maternal patient populations

Eunice Kennedy Shriver国家儿童健康和人类发展研究所（NICHD） 为国际妇幼青少年艾滋病临床研究中心提供临床试验场地 试验组（IMPAACT）。IMPAACT网络及其领导小组监督所有 他们的研究方案和临床试验IMPAACT网络是一个合作组织， 研究机构、研究人员和其他合作者主要集中在评估潜在的 治疗艾滋病毒感染及其相关症状和婴儿，儿童， 青少年和孕妇。这包括对艾滋病毒/艾滋病干预措施的临床试验， 预防母婴传播。 IMPAACT网络的目标是进行高质量的临床试验和/或方案， * 促进对婴儿、儿童、 全球青少年和孕妇/产后妇女。本任务中的IMPAACT研究议程 该命令包括四个具体的科学目标，反映了工作的关键领域。这些地区 HIV治疗、HIV预防、HIV治愈和HIV并发症。对于每一个领域， 委员会由特定领域的专家、现场调查员、社区代表组成， 和中央网络资源的代表，不断重新评估研究 优先考虑新兴科学以及新的想法和机会;它寻求 与其他试验网络和研究实体合作;监督制定和审查 根据科学优先事项制定研究概念计划;并监测 在特定研究领域开展经批准的网络研究。 1990年，NICHD开始与儿科艾滋病临床试验组合作， （PACTG）扩大NICHD临床试验中心/研究中心的临床试验可用性。 这 使合作成为可能， 进行 IMPAACT网络的临床试验， 进一步评估抗逆转录病毒治疗药物，其他 疗法 针对性 在 机会性 感染， 和 干预措施 到 预防围产期 艾滋病毒传播。 近年来，这种合作正在扩大到评估潜在的艾滋病毒治愈方法 方法和疫苗。 本任务指令旨在招募、遵循和完成IMPAACT相关方案 列在下面。这两个协议的结果的整合，将在一个 最终报告将提供数据，以推进艾滋病毒的预防，治疗和缓解，其最 孕产妇、青少年和儿童常见并发症及相关传染病 人口。 在过去的35年里，NICHD/NIAID作为科学界的一部分， 艾滋病毒研究。在这段时间里，很明显，要想成功地扭转局面， 艾滋病病毒感染率的流行，并适当对待个人的感染过程， 需要对艾滋病毒研究采取综合和全面的办法。此外，NICHD/NIAID和 科学界的其他人在90年代中期发现， 抗逆转录病毒药物（ARV）不足以适当地治疗个体HIV感染。 因此，需要三种或更多种药物（ARV）的协同作用，以有效地治疗和保持 防止个人感染艾滋病病毒。出于这个原因，开发和测试多种抗逆转录病毒药物， 不同的试验是必要的。这就需要在全球范围内开发和测试多种抗逆转录病毒药物， 不同的审判与此同时，一旦一种药物被开发和批准， 需要进行试验，以确定它们之间的潜在协同作用。 现在科学界已经知道，最初的尝试，以实现艾滋病毒治愈 （缓解）可能需要多种抗逆转录病毒药物的相互作用，除了早期开始治疗外， 感染后的治疗（本任务顺序中的临床方案）加上被动 免疫疗法加长效抗逆转录病毒疗法（正在按任务顺序方案进行研究） and possibly可能even therapeutic治疗vaccines疫苗. DocuSign信封ID：B345 E7 A5-BACD-4AAE-9195-449332381126 2 因此，很明显，尽管所有的个体试验（方案）都可以提供非常有用的 信息，从一些不同的协议中获得的知识的集成将 提供更全面的数据分析，以进行更好的科学评估， 确定预防和治疗艾滋病毒及其并发症的最佳方法， 孕产妇、青少年和儿科人群的合并症。 虽然单个方案很重要，但按照本任务顺序完成2个方案， 必须收到最终报告，其中包括来自这些方案的综合数据 因为如果没有NICHD和IMPAACT网络， 问题研究同样明显的是，综合结果最终可能有助于实现 更好和持续的艾滋病毒缓解，以及更有效的艾滋病毒预防和治疗， 儿科、青少年和孕产妇患者人群中的其他相关传染病