NCT00002296已完成不适用
A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
Newport Pharmaceuticals International2 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
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters:
- Increase in natural killer (NK) cell activity.
- Increase in total T-cells (OKT-11).
- Increases in absolute number and percentage of T-helper cells (OKT-4).
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Exclusion Criteria
- •Co-existing Condition:
- •Patients with the following are excluded:
- •History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction and severe gastric ulcer.
- •Lymphoid malignancy.
- •Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus.
- •Heart disease (especially if receiving cardiac glycosides).
- •Hemophilia.
- •Patients with the following are excluded:
- •Kaposi's sarcoma or overt opportunistic infections as follows:
- •Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus.
- •Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV).
- •History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.
- •Critical illness.
- •Condition requiring hospitalization.
- •Women of childbearing age are excluded.
- •Hemophilia.
- •Prior Medication:
- •Steroids.
- •Cytotoxic immunosuppressive agents.
- •Antiviral medicine.
- •Prior Treatment:
- •Radiotherapy.
- •Patients who have unexplained immunodepression and are at risk of developing AIDS.
- •Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites).
- •IV drug abuse.
排除标准
- 未提供
研究者
研究点 (2)
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