PHASE I STUDY OF PHARMACOKINETICS, SAFETY AND ACCEPTABILITY OF A SINGLE DOSE OF PRETOMANID ADDED TO AN OPTIMIZED BACKGROUND REGIMEN IN CHILDREN WITH RIFAMPICIN RESISTANT TUBERCULOSIS IMPAACT 2034

对患有利福平耐药结核病儿童的单剂量 Pretomanid 的药代动力学、安全性和可接受性的 I 期研究添加到优化背景方案中的影响 2034

• 批准号: 10679271
• 负责人: BARBARA DRIVER
• 金额: $ 29.94万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-03 至 2025-12-15
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10679271
• 关键词: 18 year old; AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Adolescent; Adult; Aftercare; Anti-Retroviral Agents; Area; Body Weight; Child; Childhood; Clinical Trials; Collaborations; Communities; Conduct Clinical Trials; Development; Disease remission; Dose; Drug Kinetics; Enrollment; Epidemic; Formulation; Future; Goals; HIV; HIV Infections; HIV therapy; Individual; Infant; Infection; Institution; International Maternal Pediatric Adolescent AIDS Clinical Trials; Intervention; Leadership; Light; Monitor; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; Opportunistic Infections; Oral; Participant; Passive Immunotherapy; Pharmaceutical Preparations; Postpartum Women; Pregnant Women; Prevention; Process; Protocols documentation; Regimen; Research; Research Personnel; Research Priority; Resources; Rifampicin resistance; Safety; Science; Site; Symptoms; Tablets; Testing; Therapeutic Agents; Time; Treatment Protocols; Tuberculosis; Vaccines; Vertical Disease Transmission; Work; antiretroviral therapy; base; co-infection; infection rate; perinatal HIV; phase 1 study; pregnant; prevent; study population; synergism; targeted treatment; therapeutic vaccine; transmission process; tuberculosis treatment; 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 AIDS Clinical Trials Group (ACTG) and subsequently, in 1996 with the Pediatric AIDS Clinical Trials Group (PACTG) to expand clinical trial availability at NICHD clinical trial centers/sites. This collaboration made it possible to conduct clinical trials by the IMPAACT Network to further evaluate anti-retroviral 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. For the last 35 years, NICHD and the National Institute of Allergy and Infectious Diseases (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 curb 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 are essential. 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 (plus the potential use of passive immunotherapy plus long-term acting anti-retroviral therapy) and even therapeutic vaccines.

尤尼斯·肯尼迪·施莱弗国家儿童健康和人类发展研究所(NICHD)为国际母儿青少年艾滋病临床试验小组(IMPAACT)提供临床试验场地。IMPAACT网络及其领导小组监督他们所有研究、方案和临床试验的创建。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，主要侧重于评估艾滋病毒感染及其相关症状和婴儿、儿童、青少年和孕妇合并感染的潜在治疗方法。这包括预防母婴传播的艾滋病毒/艾滋病干预措施的临床试验。 IMPAACT网络的目标是进行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/产后妇女预防和治疗艾滋病毒及其并发症。在这一任务顺序中，亚太技转中心的研究议程包括四个具体的科学目标，它们反映了工作的关键领域。那些地区 艾滋病毒治疗、艾滋病毒预防、艾滋病毒治疗和艾滋病毒并发症。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的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，不断重新评估研究优先事项；寻求与其他试验网络和研究实体合作；监督根据科学优先事项制定和审查研究概念计划；并监测特定研究领域经批准的网络研究的发展和实施情况。 1990年，NICHD开始与艾滋病临床试验小组(ACTG)合作，随后在1996年与儿科艾滋病临床试验小组(PACTG)合作，以扩大NICHD临床试验中心/地点的临床试验供应。这种合作使IMPAACT网络能够进行临床试验，以进一步评估抗逆转录病毒治疗剂、针对机会性感染的其他疗法以及预防围产儿的干预措施 艾滋病毒的传播。近年来，合作范围正在扩大，以评估潜在的艾滋病毒治愈方法和疫苗。 在过去的35年里，NICHD和国家过敏和传染病研究所(NIAID)作为科学界的一部分，一直在进行紧张的艾滋病毒研究。 在此期间，人们清楚地认识到，要想成功地遏制这一流行病的艾滋病毒感染率，并适当地治疗个人的感染过程，就必须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，一种甚至两种不同的抗逆转录病毒药物(ARV)不足以适当地治疗单个艾滋病毒感染。因此，需要三种或三种以上药物(抗逆转录病毒药物)的协同作用，才能有效地治疗和遏制单个艾滋病毒感染。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。与此同时，一旦一种药物被开发和批准，就需要进行多项其他试验，以确定它们之间的潜在协同作用。 科学界现在知道，实现艾滋病毒治愈(缓解)的最初尝试可能需要多种抗逆转录病毒药物的相互作用，此外还需要在感染后及早开始治疗(加上可能使用被动免疫疗法加上长期有效的抗逆转录病毒疗法)，甚至需要治疗性疫苗。