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.

Eunice Kennedy Shriver国家儿童健康与人类发展研究所（NICHD）为国际孕产妇青少年艾滋病临床试验小组（Impaact）提供临床试验地点。 Incract网络及其领导力小组监督了所有研究，协议和临床试验的创建。这些活动是通过Niaid赞助的赠款/合作协议来资助的。 Incract网络是一个合作的机构，研究人员和其他合作者，主要致力于评估婴儿，儿童，青少年和孕妇的HIV感染及其相关症状及其相关症状和共同感染的潜在疗法。这包括艾滋病毒/艾滋病干预措施的临床试验，以预防母亲传播母亲。 不可行的网络目标是进行高质量的临床试验和/或方案，以推动对艾滋病毒的预防和治疗及其对婴儿，儿童，青少年以及全球孕妇/产后妇女的并发症。此任务顺序中不可行的研究议程包括四个科学特定的目的，这些目标反映了工作的关键领域。这些领域是艾滋病毒治疗，预防艾滋病毒，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，现场调查人员，社区代表和中央网络资源代表组成的科学委员会不断根据新兴的科学以及新的思想和机会来重新评估研究的优先事项；它寻求与其他试验网络和研究实体的合作；根据科学的优先事项监督研究概念计划的制定和审查；并监视特定研究领域的批准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组（PACTG）合作，以扩大NICHD临床试验中心/站点的临床试验可用性。这项合作使Incract网络的临床试验成为可能，以进一步评估抗逆转录病毒治疗剂，针对机会感染的其他疗法以及防止围产期HIV传播的干预措施。近年来，该合作正在扩大，以评估潜在的HIV治疗方法和疫苗。 此任务订单的目的是招募，遵循和完成下面列出的与不可行的协议。将在最终报告中提出的这8种方案的结果的整合将提供数据，以提高艾滋病毒的预防，治疗和缓解，其最常见的并发症和相关的感染性疾病在母亲，青少年和儿科人群中。 在过去的35年中，NICHD/NIAID作为科学界的一部分一直在进行强烈的艾滋病毒研究。在此期间，很明显，在尝试弯曲流行病的艾滋病毒感染率并适当地治疗个体感染过程的尝试中取得成功，需要采取综合而全面的艾滋病毒研究方法。此外，在90年代中期发现的科学界的NICHD/NIAID和其他人中，一种甚至两种不同的抗逆转录病毒药物（ARV）不足以适当治疗单个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并保持单独的HIV感染。因此，在不同试验中对多个ARV的开发和测试至关重要。这需要在不同试验中开发和测试多个ARV。同时，一旦开发并批准了药物，就需要进行其他多项试验来辨别它们之间的潜在协同作用。 现在，科学界已经知道，除了感染后的治疗（该任务顺序中的临床方案）外，还需要使用多种ARV的初步尝试（缓解）可能需要与多个ARV进行相互作用，加上被动免疫治疗的潜在使用长期行动抗逆转录病毒疗法（在一项任务方案中进行的长期表演协议中的研究）和可能的实用。 因此，很明显，尽管所有单个试验（协议）都可以提供非常有用的信息，但是从某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，这将导致更好的科学评估，以确定艾滋病毒的最佳方法及其对艾滋病毒的最佳方法及其孕产妇，青少年，青少年和花生人群中的并发症和合并症。 尽管单个协议很重要，但在此任务顺序中完成了8个协议的完成和最终报告的接收（包括所有这些协议的集成数据）是必要的，因为如果不是NICHD，并且不可能且不可能的网络可能会失去这些研究的全面性质的一部分。同样明显的是，结合结果最终可能有助于实现更好，持续的HIV缓解，以及针对儿科，青少年和孕妇患者人群的HIV和其他相关感染疾病的更有效的预防和治疗。