NCT00002297已完成不适用
A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained 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 objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include:
Signs and symptoms:
- Lymphadenopathy.
- Fever.
- Weight loss.
- Occurrence of opportunistic infections.
Cell-mediated immune system parameters:
- T-helper cell (OKT4) numbers and proportions.
- T-suppressor cell (OKT8) numbers and proportions.
- Natural killer (NK) cell activity.
- Lymphocyte blastogenic response to phytohemagglutinin (PHA).
- Lymphocyte blastogenic response to pokeweed mitogen (PWM).
- Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.
- Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora.
Safety parameters:
- Blood chemistry including serum uric acid (PurposeA-12).
- Complete blood count (CBC).
- Platelet count.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Exclusion Criteria
- •Co-existing Condition:
- •Patients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded.
- •Concurrent Medication:
- •Systemic corticosteroids.
- •Cytotoxic immunosuppressive agents.
- •Radiotherapy.
- •Critically ill patients or those with CDC-defined AIDS are excluded.
- •Prior Medication:
- •Excluded within 1 month of study entry:
- •Immunotherapy.
- •Patients with persistent generalized lymphadenopathy (PGL).
排除标准
- 未提供
研究者
研究点 (2)
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