NCT00002037已完成不适用
Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
To examine the effectiveness of subcutaneous gamma interferon in reducing severity of Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence and absence of AZT therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Diagnosis of AIDS and persistent Mycobacterium avium- intracellulare (MAI) bacillemia.
- •Life expectancy of at least 3 months.
- •Baseline chest X-ray and EKG (electrocardiogram).
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Known hypersensitivity to interferons or other exogenous lymphokine.
- •History of cardiac abnormality or disease.
- •History of hypertension.
- •Patients with the following are excluded:
- •Known hypersensitivity to interferons or other exogenous lymphokine.
- •History of cardiac abnormality or disease.
- •History of hypertension.
- •Prior Medication:
- •Excluded within 4 weeks of study entry:
- •Corticosteroids.
- •Anti-inflammatory medication (except aspirin).
- •Changes in the dose of anti-mycobacterial drugs.
- •Immune agents.
- •Prior Treatment:
- •Excluded within 4 weeks of study entry:
- •Radiotherapy.
- •Risk Behavior:
- •Intravenous drug abuse.
研究者
研究点 (1)
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