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

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 我们对导致艾滋病的病毒以及艾滋病本身的大量了解都是通过研究非人类灵长类动物（NHP）模型获得的。人类HIV/AIDS与猿类SIV/AIDS之间的许多相似之处为在猿类模型中实验研究病毒致病性和疾病干预策略提供了基础，对人类疾病的理解和治疗具有直接意义。此外，使用NHP进行临床前药物测试以确认对高度相似的病毒和疾病的疗效的重要性被认为是将这些急需的治疗剂转移到人体临床试验中的最快实验方法。临床前试验被认为是候选人用药物批准过程中的必要步骤。FDA所谓的“两种动物规则”适用于候选艾滋病药物，在两种动物模型中证明的安全性和有效性可能导致立即许可用于人类。NHP是公认的理想的第二或非啮齿类动物模型。这对于免疫系统附着的通过穿过粘膜感染的感染因子（如HIV）尤其如此。原型研究涉及4至6组，每组5或6只动物。每组在抗病毒药物（通常以多种浓度递送至每个治疗组）或模拟治疗后或同时接受经验证的病毒储备的挑战。药物效力由感染挑战的结果和病毒感染相对于模拟处理对照的限制程度决定。此外，在疗效试验期间评价局部和全身候选药物毒性。