THE ESTABLISHMENT OF AIDS CLINICAL TRIALS UNIT

艾滋病临床试验单位的建立

• 批准号: 3547452
• 负责人: RUY SOEIRO
• 金额: $ 155.87万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-06-30 至 1995-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3547452
• 关键词: AIDS; AIDS therapy; HIV infections; clinical trials; cooperative study; human subject; human therapy evaluation

This grant request (RFA) is for the establishment (continuation) of an adult clinical trials program for the testing of drugs for the treatment of patients with HIV-1 infection. The major thrust of the trials will be phase II/III protocols to test efficacy of newer types and combinations of antiviral agents to determine the optimal approach to treat early (often asymptomatic), later, (with significant immunocompromised state) HIV (+) patients, as well as those intolerant to current accepted therapy. In addition, protocols for new agents and combinations of agents to treat opportunistic infections, malignancies, and neurological disease associated with AIDS will undergo clinical trials. DEVELOPMENTAL PHARMACOLOGY: Development of novel assays to measure the intracellular levels of AZT to understand the role of acetylation kinetics in sulfonamide intolerance in AIDS patients. DEVELOPMENTAL IMMUNOLOGY: Coordination of soluble cell markers of cellular activation with virus expression by Flow Cytometry of intracellular HIV-1 p24. DEVELOPMENTAL PARASITOLOGY: Study of the growth, detection by Polymerase Chain Reaction, and therapy of Microsporidiosis.

该拨款请求（RFA）旨在建立（延续） 用于测试治疗药物的成人临床试验计划 HIV-1 感染患者。 试验的主要重点将是 II/III 期方案，用于测试新类型和组合的功效 抗病毒药物以确定早期治疗的最佳方法（通常 无症状），后来（具有明显的免疫功能低下状态）HIV (+) 患者，以及那些对目前接受的治疗不耐受的患者。 在 此外，新药和治疗药物组合的方案 机会性感染、恶性肿瘤和神经系统疾病相关 患有艾滋病的患者将接受临床试验。 发育药理学：开发新的测定方法来测量 细胞内 AZT 水平以了解乙酰化动力学的作用 艾滋病患者对磺胺类药物不耐受。 发育免疫学：细胞可溶性细胞标记物的协调 通过流式细胞术检测细胞内 HIV-1 的病毒表达激活 第 24 页。 发育寄生虫学：生长研究、聚合酶检测 链式反应和微孢子虫病的治疗。