Preclinical Development Services for AIDS Therapeutics: Pharmacology and Toxicology

艾滋病治疗的临床前开发服务：药理学和毒理学

• 批准号: 10244539
• 负责人: JON MIRSALIS
• 金额: $ 131.45万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-15 至 2021-07-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10244539
• 关键词: Acquired Immunodeficiency Syndrome; Anti-Retroviral Agents; Biological Assay; Contracts; Development; Development Plans; Drug Kinetics; Formulation; HIV; HIV Infections; HIV therapy; Inhalation; Intervention; Mitochondria; Mus; National Institute of Allergy and Infectious Disease; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology and Toxicology; Rattus; Research Personnel; Services; Tenofovir; Therapeutic; Therapeutic Agents; Toxic effect; Toxicology; United States Dept. of Health and Human Services; United States National Institutes of Health; clinical investigation; co-infection; drug development; microbicide; nanoformulation; preclinical development; prevent; sexual HIV transmission; transmission process; tuberculosis drugs

The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), maintains a portfolio of contracts to support the development of (1) therapies for HIV infection and its complications and coinfections, and (2) microbicides for preventing the sexual transmission of HIV. Services provided under this contract assist investigators in academic settings and small pharmaceutical firms in filling specific gaps in their drug development plan as they advance their product towards clinical investigation of therapies for HIV infection and interventions to prevent HIV transmission. Activities will include the development of formulations of potential therapeutic agents and microbicides. In addition studies will be conducted to assess the pharmacology and toxicology of potential therapeutic agents and microbicides. This project will support the following activities: Toxicology studies of tenofovir nanformulation with pharmacokinetics in mice; inhalation studies with clofazimine in ratsl and development of mitochondrial toxicity assays for mitochondrial toxicity assessment

国家过敏和传染病研究所(NIAID)艾滋病司(DAIDS)、国家卫生研究院(NIH)、卫生与公众服务部(DHHS)维持着一系列合同，以支持开发(1)艾滋病毒感染及其并发症和混合感染的治疗方法，以及(2)用于预防艾滋病毒性传播的杀微生物剂。根据该合同提供的服务帮助学术机构的研究人员和小型制药公司填补其药物开发计划中的具体空白，因为他们将其产品推向艾滋病毒感染疗法的临床调查和预防艾滋病毒传播的干预措施。活动将包括开发潜在的治疗剂和杀微生物剂的配方。此外，还将进行研究，以评估潜在的治疗剂和杀微生物剂的药理学和毒理学。该项目将支持以下活动：替诺福韦纳米制剂在小鼠体内的毒理学研究和药代动力学；氯法齐明在大鼠体内的吸入研究以及用于线粒体毒性评估的线粒体毒性测试方法的建立。