AIDS THERAPIES

艾滋病治疗

• 批准号: 7716387
• 负责人: Che-Chung Tsai
• 金额: $ 42.21万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716387
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Animal Model; Animals; Anti-HIV Agents; Antiviral Agents; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Drug toxicity; Funding; Grant; HIV; Human; Immune system; Infectious Agent; Institution; Intervention; Licensure; Methods; Modeling; Mucous Membrane; Outcome; Pathogenicity; Pharmaceutical Preparations; Process; Research; Research Personnel; Resources; Rodent; Safety; Source; Therapeutic Agents; United States National Institutes of Health; Virus; Virus Diseases; base; drug efficacy; drug testing; efficacy trial; human disease; nonhuman primate; pre-clinical; preclinical study; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Animal Model; Animals; Anti-HIV Agents; Antiviral Agents; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Drug toxicity; Funding; Grant; HIV; Human; Immune system; Infectious Agent; Institution; Intervention; Licensure; Methods; Modeling; Mucous Membrane; Outcome; Pathogenicity; Pharmaceutical Preparations; Process; Research; Research Personnel; Resources; Rodent; Safety; Source; Therapeutic Agents; United States National Institutes of Health; Virus; Virus Diseases; base; drug efficacy; drug testing; efficacy trial; human disease; nonhuman primate; pre-clinical; preclinical study

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A great deal of our understanding of the viruses that cause AIDS as well as the disease itself has been acquired through study of nonhuman primate (NHP) models. Numerous similarities between human HIV/AIDS and simian SIV/AIDS provide the basis to experimentally study virus pathogenicity and disease intervention strategies in simian models with direct implications for the human disease understanding and treatment. Further, the importance of using NHP for preclinical drug testing to confirm efficacy against a highly similar virus and disease is recognized as the quickest experimental method to move these much need therapeutic agents into human clinical trials. Preclinical trials have been deemed a necessary step in the approval process for candidate human drugs. The FDA's so called "two animal rule" applies to candidate AIDS drugs whereby safety and efficacy demonstrated in two animal models could result in immediate licensure for human use. NHP are recognized as the ideal second or non-rodent animal model. This is particularly true for immune system attaching infectious agents that infect by traversing mucous membranes as does HIV. Prototypical studies involve 4 to six groups of 5 or 6 animals. Each group is challenged by a proven virus stock after or concurrently with antiviral (usually delivered in multiple concentrations to each treated group) or mock-treatment. Drug efficacies are determined by the outcomes of the infectious challenges and the degree -with respect to the mock-treated controls that the virus infections are limited. Additionally, local and systemic candidate drug toxicity are evaluated during efficacy trials.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 通过研究非人类灵长类动物（NHP）模型，我们对引起艾滋病以及疾病本身的病毒的了解很多。人类艾滋病毒/艾滋病和猿猴/艾滋病/艾滋病之间的许多相似之处为实验研究病毒致病性和疾病干预策略的基础在邻速模型中对人类疾病的理解和治疗有直接影响。此外，使用NHP进行临床前药物测试来确认对高度相似病毒和疾病的功效的重要性被认为是将这些急需的治疗剂转移到人类临床试验中的最快实验方法。临床前试验被认为是候选人类药物批准过程中必要的步骤。 FDA所谓的“两种动物规则”适用于候选艾滋病药物，在两个动物模型中证明的安全性和功效可能会导致人类使用的立即许可。 NHP被认为是理想的第二或非塑性动物模型。对于接触传染剂的免疫系统尤其如此，这些传染剂像艾滋病毒一样通过遍历粘膜。原型研究涉及4至6组5或6只动物。每个组都受到验证的病毒库存的挑战，或者是与抗病毒（通常以多个浓度输送到每个治疗组的多种浓度）或模拟处理的挑战。药物效率取决于感染性挑战的结果以及与模拟治疗的控制有关病毒感染受到限制的控制的程度。此外，在功效试验期间还评估了局部和系统的候选药物毒性。