HIV AND OTHER IMPAACT RELATED INFECTIOUS DISEASE STUDIES

艾滋病毒和其他影响相关的传染病研究

• 批准号: 9916163
• 负责人: BARBARA DRIVER
• 金额: $ 1279.14万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2024-03-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9916163
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Adolescent; Aftercare; Anti-Retroviral Agents; Area; Child; Childhood; Clinical; Clinical Protocols; Clinical Trials; Collaborations; Communicable Diseases; Communities; Comorbidity; Conduct Clinical Trials; Data; Data Analyses; Development; Diagnosis; Disease remission; Epidemic; Epidemiology; Formulation; Funding; Goals; Grant; HIV; HIV Infections; HIV therapy; Individual; Infant; Infection; Institution; International; International Maternal Pediatric Adolescent AIDS Clinical Trials Group; 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; Preventive Intervention; Process; Protocols documentation; Reporting; Research; Research Personnel; Research Priority; Resources; Science; Site; Symptoms; Testing; Therapeutic Agents; Time; U-Series Cooperative Agreements; Vaccines; Vertical Disease Transmission; Work; antiretroviral therapy; base; co-infection; patient population; perinatal HIV; pregnant; prevent; recruit; synergism; targeted treatment; therapeutic vaccine; 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. These activities are funded through Grants/Cooperative agreements sponsored by NIAID. 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 8 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 therapeutic vaccines. 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 8 protocols in this task order and receipt of the final report, which includes the integrated data from all 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组 (IMPAACT) 提供临床试验场所。 IMPAACT 网络及其领导小组负责监督所有研究、方案和临床试验的创建。这些活动由 NIAID 赞助的赠款/合作协议资助。 IMPAACT 网络是一个由机构、研究人员和其他合作者组成的合作小组，主要致力于评估婴儿、儿童、青少年和孕妇艾滋病毒感染及其相关症状和合并感染的潜在疗法。这包括预防母婴传播艾滋病毒/艾滋病干预措施的临床试验。 IMPAACT 网络的目标是开展高质量的临床试验和/或方案，以促进全球婴儿、儿童、青少年和孕妇/产后妇女的艾滋病毒及其并发症的预防和治疗。该任务顺序中的 IMPAACT 研究议程包括四个科学具体目标，反映了工作的关键领域。这些领域是艾滋病毒治疗、艾滋病毒预防、艾滋病毒治愈和艾滋病毒并发症。对于每个领域，由特定领域的专家、现场调查员、社区代表和中央网络资源代表组成的科学委员会，根据新兴科学以及新的想法和机会不断重新评估研究重点；它寻求与其他试验网络和研究实体的合作；根据科学优先事项监督研究概念计划的制定和审查；并监督特定研究领域经批准的网络研究的开发和实施。 1990 年，NICHD 开始与儿科艾滋病临床试验小组 (PACTG) 合作，扩大 NICHD 临床试验中心/场所的临床试验可用性。此次合作使得 IMPAACT 网络能够开展临床试验，以进一步评估抗逆转录病毒治疗药物、针对机会性感染的其他疗法以及预防围产期艾滋病毒传播的干预措施。近年来，合作范围正在扩大，以评估潜在的艾滋病毒治疗方法和疫苗。 此任务订单的目的是招募、遵循并完成下面列出的 IMPAACT 相关协议。这 8 项方案的结果将在最终报告中进行整合，将为促进孕产妇、青少年和儿科人群的艾滋病毒及其最常见并发症和相关传染病的预防、治疗和缓解提供数据。 过去 35 年来，NICHD/NIAID 作为科学界的一部分，一直在开展深入的艾滋病毒研究。在此期间，人们清楚地认识到，要成功地控制该流行病的艾滋病毒感染率并适当对待个体感染过程，就需要对艾滋病毒研究采取综合全面的方法。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，需要三种或多种药物（ARV）的协同作用才能有效治疗和预防个体艾滋病毒感染。因此，在不同的试验中开发和测试多种抗逆转录病毒药物至关重要。这需要在不同的试验中开发和测试多种抗逆转录病毒药物。与此同时，药物一旦开发出来并获得批准，就需要进行多项其他试验来辨别它们之间潜在的协同作用。 现在科学界知道，除了感染后尽早开始治疗（本任务顺序中的临床方案）外，实现 HIV 治愈（缓解）的初步尝试可能需要多种抗逆转录病毒药物的相互作用。可能使用被动免疫疗法加上长期作用的抗逆转录病毒疗法（正在任务顺序协议中研究），甚至可能使用治疗性疫苗。 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信息，但从一些不同方案中获得的知识的整合将提供更全面的数据分析，从而进行更好的科学评估，以确定最佳方案预防和治疗孕产妇、青少年和儿科人群的艾滋病毒及其并发症和合并症的方法。 虽然各个协议很重要，但必须完成此任务订单中的 8 个协议并收到最终报告（其中包括所有这些协议的综合数据），因为如果不完成，NICHD 和 IMPAACT 网络可能会失去部分综合性这些研究。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，以及更有效地预防和治疗儿科、青少年和孕产妇患者群体中的艾滋病毒和其他相关传染病。