AIDS THERAPIES II

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 康拉德是一家非营利性机构，专注于全球生殖健康。本项目旨在开发一种新的临床前动物模型系统，用于评估抗病毒微生物剂。通过对非人灵长类动物(NHP)模型的研究，我们对导致艾滋病的病毒以及疾病本身的了解得到了很大程度的提高。人类HIV/AIDS和猴SIV/AIDS之间的许多相似之处为在猴模型中实验研究病毒的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的意义。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有效性的重要性被认为是将这些急需的治疗剂投入人类临床试验的最快实验方法。临床前试验被认为是候选人类药物审批过程中的必要步骤。FDA所谓的“两只动物规则”适用于艾滋病候选药物，根据这一规则，在两个动物模型中证明的安全性和有效性可以立即获得人类使用的许可。NHP被认为是理想的第二或非啮齿动物模型。对于免疫系统附着的感染性病原体来说尤其如此，这些病原体通过穿越粘膜进行感染，就像艾滋病毒一样。这个最初的项目集中在确定一种新的含有HIV逆转录酶(RT)基因的猴艾滋病研究病毒的猕猴感染量(MID)。这一临床前模型将被用于评估NHP中针对HIV的抗RT药物。

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.