NCT00002248已完成1 期
A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients
Univax Biologics Inc11 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 11
研究概览
简要总结
PRIMARY: To assess the effect of bovine anti-Cryptosporidium immunoglobulin (BACI) on the volume of diarrhea due to Cryptosporidium parvum in AIDS patients who have protracted Cryptosporidium enteritis.
SECONDARY: To assess changes in stool consistency and frequency, body weight, and safety in this patient population.
详细描述
Forty patients are randomized to receive either BACI or placebo (bovine colostrum from non-immunized cattle) for 1 week. The double-blind portion of the study will be followed by an open-label phase in which all 40 patients receive BACI for 1 week.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Antidiarrheal compounds (if dose remains stable).
- •Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose was stable for at least 4 weeks prior to study entry).
- •Patients must have:
- •Cryptosporidium parvum enteritis.
- •Chronic diarrhea.
- •Life expectancy of at least 4 weeks.
- •Ability to tolerate food by mouth.
- •Ability to take the histamine H2-receptor antagonist famotidine (Pepcid).
- •Prior Medication:
- •Antidiarrheal compounds (provided dose has remained stable in the 7 days prior to study entry).
- •Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose has remained stable for at least 4 weeks prior to study entry).
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Concurrent unresolved clinical infections with enteric pathogens other than C. parvum (e.g., rotavirus, Salmonella, Shigella, Campylobacter, Giardia, C. difficile toxin, Yersinia, amebiasis, MAI, CMV, Microsporida) as determined by history or routine microbiology screening.
- •Other acute infections or concurrent immediately life-threatening medical crisis other than cryptosporidiosis.
- •Grossly bloody diarrhea.
- •Known allergy to milk or milk products (other than lactose intolerance).
- •Prior Medication:
- •Other experimental therapy (e.g., macrolide antibiotics, paromomycin) within 30 days prior to study entry.
研究者
研究点 (11)
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