NCT00002121已完成1 期
Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
VA Medical Center-Gainesville2 个研究点 分布在 1 个国家开始时间: 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
- 试验地点
- 2
研究概览
简要总结
To perform preliminary clinical testing of diethylhomospermine (DEHSPM), a polyamine analogue, for refractory AIDS-related diarrhea.
Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory AIDS-related diarrhea.
详细描述
Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory AIDS-related diarrhea.
Patients are initially hydrated for 24 hours, followed by a 3-day baseline period. They then receive intravenous infusions of DEHSPM three times per day for 3 days, followed by observation for 3 days.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •ARC or AIDS by CDC criteria.
- •Uncontrolled diarrhea unresponsive to high-dose, nonspecific antidiarrheal therapy.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Known idiopathic ulcerative colitis or Crohn colitis.
- •Acute stool-culture-positive bacterial colitis.
- •Acute amoebic colitis.
- •Pseudomembranous colitis with Clostridium difficile toxin positivity.
- •Short-gut syndrome.
- •Chronic pancreatitis.
- •Ischemic bowel disease.
- •Enteroenteric fistulae.
- •Other gastrointestinal tract disorders known to cause diarrhea.
- •Underlying evidence of immunosuppression other than that related to HIV infection.
- •Unable or unwilling to have subcutaneous injections.
- •Clinically significant CNS, hepatic, or renal disease.
- •Concurrent Medication:
- •Other experimental antidiarrheal drugs.
- •Antibiotic therapy.
- •Prior Medication:
- •Other experimental drugs within 1 month prior to study entry.
- •At least 2 weeks of prior high-dose, nonspecific antidiarrheal therapy (i.e., loperamide, diphenoxylate hydrochloride-atropine sulfate, or opiates) at maximally tolerable doses.
研究者
研究点 (2)
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