AIDS THERAPIES II

艾滋病治疗二

• 批准号: 7716388
• 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/7716388
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Animal Model; Animals; Anti-HIV Agents; Antiviral Agents; Biological Models; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Dose; Funding; Genes; Grant; HIV; Human; Immune system; Infectious Agent; Institutes; Institution; Intervention; Licensure; Macaca; Methods; Modeling; Mucous Membrane; Pathogenicity; Pharmaceutical Preparations; Pre-Clinical Model; Process; Purpose; RNA-Directed DNA Polymerase; Reproductive Health; Research; Research Personnel; Resources; Rodent; Safety; Simian Acquired Immunodeficiency Syndrome; Source; Therapeutic Agents; United States National Institutes of Health; Virus; Virus Diseases; base; design; drug testing; human disease; microbicide; 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. CONRAD is a nonprofit institute with a focus on global reproductive health. This project was design to develop a new preclinical animal model system for the purpose of evaluating antiviral microbicides. 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. This initial project focused on determining the macaque infectious dose (MID) of a new simian AIDS research virus containing the HIV reverse transcriptase (RT) gene. This preclinical model will be used to evaluate HIV-specific anti-RT drugs in NHP.

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。 康拉德（Conrad）是一家非营利研究所，重点是全球生殖健康。该项目的设计旨在开发一种新的临床前动物模型系统，目的是评估抗病毒杀菌剂。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。这个最初的项目侧重于确定含有HIV逆转录酶（RT）基因的新的Simian AIDS研究病毒的猕猴感染剂量（MID）。该临床前模型将用于评估NHP中HIV特异性抗RT药物。