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

尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 为国际孕产妇儿科青少年艾滋病临床试验提供临床试验场地 试验组（IMPAACT）。 IMPAACT 网络及其领导小组负责监督所有 他们的研究、方案和临床试验。 IMPAACT 网络是一个合作团体 机构、研究人员和其他合作者主要关注评估潜在的 针对婴儿、儿童、艾滋病毒感染及其相关症状和合并感染的治疗 青少年和孕妇。这包括艾滋病毒/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/或协议， 推进婴儿、儿童、艾滋病毒及其并发症的预防和治疗 全球青少年和孕妇/产后妇女。本任务中的 IMPAACT 研究议程 命令包括四个科学具体目标，反映了工作的关键领域。这些区域是 HIV 治疗、HIV 预防、HIV 治愈和 HIV 并发症。对于每个领域，都有一个科学的 委员会由特定领域的专家、现场调查员、社区代表、 和中央网络资源的代表，不断重新评估研究 根据新兴科学以及新想法和机遇确定优先事项；它寻求 与其他试验网络和研究实体的合作；监督制定和审查 基于科学优先事项的研究概念计划；并监控事态的发展和 在特定研究领域实施经批准的网络研究。 1990 年，NICHD 开始与儿科艾滋病临床试验小组合作 (PACTG) 扩大 NICHD 临床试验中心/场所的临床试验可用性。 这 通过 IMPAACT 网络进行临床试验的合作成为可能 进一步评估抗逆转录病毒治疗药物、其他针对 机会性感染以及预防围产期艾滋病毒传播的干预措施。 近年来，合作范围不断扩大，以评估潜在的艾滋病毒治疗方法 方法和疫苗。 此任务单的目的是招募、遵循并完成 IMPAACT 相关协议 下面列出。这两个协议的结果的整合，将在 最终报告将提供数据，以推进艾滋病毒的预防、治疗和缓解，这是最重要的 孕产妇、青少年和儿科常见并发症及相关传染病 人口。 在过去 35 年里，NICHD/NIAID 作为科学界的一部分，一直在开展密集的研究 艾滋病毒研究。在此期间，很明显，要成功地扭转局势 艾滋病病毒感染率的流行，并妥善对待个体感染过程， 需要采取综合全面的方法进行艾滋病毒研究。此外，NICHD/NIAID 和 科学界的其他人在 90 年代中期发现一种甚至两种不同的 抗逆转录病毒药物 (ARV) 不足以适当治疗个体 HIV 感染。 因此，需要三种或更多药物（ARV）的协同作用才能有效治疗并保持在 避免个人感染艾滋病毒。因此，多种抗逆转录病毒药物的开发和测试 不同的尝试是必要的。这需要在多个国家开发和测试多种抗逆转录病毒药物 不同的尝试。与此同时，一旦一种药物被开发并获得批准，其他多种药物就会被开发出来并获得批准。 需要进行试验来辨别它们之间潜在的协同作用。 现在科学界已经知道，实现艾滋病毒治愈的初步尝试 （缓解）除了尽早开始治疗外，可能还需要多种抗逆转录病毒药物的相互作用 感染后的治疗（本任务顺序中的临床方案）加上潜在的被动使用 免疫疗法加长期抗逆转录病毒疗法（正在任务顺序方案中研究） 甚至可能是治疗性疫苗。 DocuSign 信封 ID：B345E7A5-BACD-4AAE-9195-449332381126 2 因此，很明显，尽管所有单独的试验（方案）都可以提供非常有用的结果 信息，从一些不同协议中获得的知识的整合将 提供更全面的数据分析，从而做出更好的科学评估 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。 虽然各个协议很重要，但完成此任务顺序中的 2 个协议和 必须收到最终报告，其中包括这些协议的综合数据 因为如果不是 NICHD 和 IMPAACT Network 可能会失去这些的部分综合性 研究。同样明显的是，综合结果最终可能有助于实现目标 更好、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群体中的其他相关传染病