NCT00002078已完成1 期
Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection
Purdue Frederick4 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
- 4
研究概览
简要总结
To determine the safety and tolerance of subcutaneous injections of natural interferon alpha (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these individuals.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •HIV-1 seropositivity.
- •CD4 count > 400/mm
- •Eligibility for care in the military medical system.
- •Prior Medication:
- •Acyclovir.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats).
- •Evidence of AIDS dementia.
- •Chronic hepatitis with severe liver dysfunction.
- •Active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, or psychiatric disorder that would limit ability to complete the study.
- •Hemophilia.
- •Co-existent disease likely to result in death within the next 2 years.
- •Known hypersensitivity to human interferon alpha.
- •Known anaphylactic hypersensitivity to mouse immunoglobulin (IgG), egg protein, or neomycin.
- •Concurrent Medication:
- •Any other concurrent experimental medications.
- •Patients with the following prior conditions are excluded:
- •History of AIDS- or ARC-defining condition (unexplained weight loss, fever, diarrhea, night sweats).
- •Evidence of chronic hepatitis with severe liver dysfunction.
- •Prior Medication:
- •Excluded within 5 days prior to study entry:
- •Immunosuppressive agents.
- •Chemotherapy.
- •Steroids.
- •Excluded within 45 days prior to study entry:
- •BCG vaccine.
- •Isoprinosine.
- •Other immune modulators.
- •Excluded within 3 months prior to study entry:
- •Any form of interferon.
- •Antiviral therapy.
- •Immunoregulatory therapy (other than acyclovir).
- •1. Active drug abuse (narcotic or alcohol abuse documented within the past 6 months).
- •Unlikely or unable to comply with the requirements of the protocol.
研究者
研究点 (4)
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