PHASE I/II OPEN LABEL EVALUATION OF NITAZOXANIDE CRYPTOSPORIDIOSIS IN AIDS

硝唑尼特隐孢子虫病治疗艾滋病的 I/II 期开放标签评估

• 批准号: 6304127
• 负责人: ROSEMARY SOAVE
• 金额: $ 7.95万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304127
• 关键词: AIDS therapy; Cryptosporidium; blood chemistry; clinical research; clinical trial phase I; cryptosporidiosis; diarrhea; dosage; drug screening /evaluation; human subject; human therapy evaluation; malabsorption; parasitic disease chemotherapy; pharmacokinetics; thiazoles; xylose

The objectives of this study are to determine the pharmacokinetics and assess safety and efficacy of nitazoxanide in patients with AIDS-related cryptosporidial diarrhea, and determine steady state concentrations of nitazoxanide following repeated dosing. Another objective is to assess the relationship between malabsorption, as determined by the d-xylose absorption test, nitazoxanide blood levels, and efficacy.

本研究的目的是确定硝唑尼特的药代动力学和评估艾滋病相关的隐孢子虫性腹泻患者的安全性和有效性，并确定硝唑尼特重复给药后的稳态浓度。 另一个目的是评估吸收不良（通过d-木糖吸收试验测定）、硝唑尼特血药浓度和疗效之间的关系。