TUBERCULOSIS PREVENTION IN CHILDREN TWO TO LESS THAN 13 YEARS OF AGE WITH AND WITHOUT HIV

感染和未感染 HIV 的 2 岁至 13 岁以下儿童的结核病预防

• 批准号: 10872953
• 负责人: Barbara Driver
• 金额: $ 222.08万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10872953
• 关键词: 13 year old; AIDS clinical trial group; AIDS prevention; Accountability; Acquired Immunodeficiency Syndrome; Administrative Coordination; Adolescent; Anti-Retroviral Agents; Area; Biological Assay; Child; Childhood; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials-Pediatric AIDS; Collaborations; Communicable Diseases; Communities; Conduct Clinical Trials; Contractor; Contracts; Counseling; Development; Diagnosis; Discipline of Nursing; Disease; Disease remission; Dose; Education; Enrollment; Ensure; Epidemic; Epidemiology; Equipment; Female of child bearing age; Formulation; Goals; HIV; HIV Infections; HIV therapy; HIV/AIDS; Human; Human Resources; Immunologics; Individual; Infant; Infection; Inpatients; Institution; Institutional Review Boards; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Intervention; Laboratories; Laboratory Technicians; Leadership; Light; Mediation; Medical; Monitor; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; Natural History; Neuropsychology; Office for Human Research Protections; Opportunistic Infections; Outpatients; Participant; Passive Immunotherapy; Patients; Pharmaceutical Preparations; Pharmacists; Phase; Postpartum Women; Pregnant Women; Prevention; Process; Protocols documentation; Qualifying; Regulation; Research; Research Activity; Research Design; Research Personnel; Research Priority; Research Subjects; Resources; Risk; Safety; Sample Size; Sampling; Science; Services; Site; Social Work; Specific qualifier value; Specimen; Specimen Handling; Symptoms; Testing; Therapeutic Agents; Time; Treatment Protocols; Tuberculosis; United States; United States National Institutes of Health; Vaccines; Vertical Disease Transmission; Visit; Work; adolescent patient; antiretroviral therapy; clinical care; clinical center; clinical research site; co-infection; cohort; design; experience; human subject; infection rate; isoniazid; laboratory facility; open label; participant enrollment; patient population; pediatric patients; perinatal HIV; pharmacologic; pregnant; prevent; recruit; research study; rifapentine; study population; synergism; targeted treatment; testing services; therapeutic vaccine; transmission process; web site; young woman

IMPAACT Related Study – Protocol 2024 –Tuberculosis – Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined with Isoniazid (1hp) for Tuberculosis Prevention in Children Two To Less Than 13 Years of Age with and Without HIV 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 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. 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 antiretroviral 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 plus the potential use of passive immunotherapy plus long-term acting antiretroviral therapy and even therapeutic vaccines.

与不相关的研究 - 方案2024 - 通结 - 第I/II期剂量发现，每日利福丁的安全性和耐受性研究以及等异尼二氮化（1HP），用于预防结核病，预防结核病，两岁至13岁以下的儿童 Eunice Kennedy Shriver国家儿童健康与人类发展研究所（NICHD）为国际孕妇小儿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。 Indaact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，社区代表组成的科学委员会，并代表中央网络资源，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；根据科学的重点监督研究概念计划的公式和审查；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AIDS临床试验组（ACTG）合作，随后，1996年，小儿AIDS临床试验组（PACTG）扩大了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。 在过去的35年中，NICHD和美国国家过敏和传染病研究所（NIAID）是科学界的一部分，一直在进行强烈的HIV研究。在这段时间里，很明显，要成功地遏制流行病的艾滋病毒感染率并适当地治疗个体感染过程，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，除了感染后的治疗早期开始，还需要进行多种ARV的初步尝试，还需要进行多种ARV的相互作用，以及潜在使用被动免疫疗法以及长期作用的抗逆转录病毒疗法，甚至是治疗疫苗。