HYPERIMMUNE EGG YOLKS FOR AIDS RELATED CRYPTOSPORIDIAL DIARRHEA

超免疫蛋黄治疗艾滋病相关的隐孢子虫腹泻

• 批准号: 6113984
• 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: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6113984
• 关键词: AIDS; AIDS therapy; clinical research; cryptosporidiosis; diarrhea; diet therapy; egg yolk; human subject; human therapy evaluation; hyperimmunization; nutrition related tag

This is an open label pilot study to assess the safety, tolerance and efficacy of hyperimmune egg yolks (IGX-CP) in patients with AIDS and cyrptosporidial diarrhea. Progress report and summary of findings: This study had been previously concluded. Analysis of findings is ongoing. Twenty-four subjects were enrolled and treated. 16 of the 24 evaluable subjects (56%) had a reduction in bowel movement frequency, and 6 subjects (38%) had a reduction in stool oocyst grade as compared with 1 subject (19%) in whom stool oocyst grade increased. No subject experienced sustained eradication of stool Cryptosporidium oocysts. While treatment was found to be safe, gastrointestinal symptoms (satiety) limited administration of IGX-CP at doses above 2.88 x10(6) AU/day.

这是一项开放标签的先导性研究，旨在评估超免疫蛋黄（IGX-CP）在艾滋病和钩端螺旋体病腹泻患者中的安全性、耐受性和有效性。进展报告和结果总结：本研究先前已完成。 正在分析调查结果。 24例受试者入组并接受治疗。 24例可评价受试者中有16例（56%）排便频率降低，6例受试者（38%）粪便卵囊等级降低，而1例受试者（19%）粪便卵囊等级升高。 无受试者持续根除粪便隐孢子虫卵囊。 虽然发现治疗是安全的，但胃肠道症状（饱腹感）限制了IGX-CP剂量高于2.88 x10（6）Au/天的给药。