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.

此赠款请求（RFA）用于建立（延续） 成人临床试验计划，用于测试药物的治疗 HIV-1感染患者。 试验的主要推力将是 II阶段/III方案，用于测试新型类型的功效和组合 抗病毒药以确定早期治疗的最佳方法（通常 无症状），以后（具有显着免疫功能低下的状态）HIV（+） 患者以及那些对当前接受疗法的不耐受。 在 补充，新代理的协议和代理的组合处理 机会主义感染，恶性肿瘤和神经疾病相关 艾滋病将接受临床试验。 发展药理学：开发新的测定法 细胞内AZT水平了解乙酰化动力学的作用 在AIDS患者中的磺酰胺不耐症中。 发育免疫学：细胞可溶性细胞标记的协调 通过细胞内HIV-1的流式细胞仪激活病毒表达 p24。 发育寄生虫学：生长研究，聚合酶检测 链反应和微孢子虫病的治疗。