NCT00002018已完成不适用
Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects
Interferon Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 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
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
To conduct a double-blind, randomized, dose ranging study of an orally administered low dose interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Zidovudine (AZT).
- •Didanosine (ddI)
- •Patients must have:
- •Seropositivity to HIV-1 by ELISA and Western blot.
- •At least 1 of the HIV-related clinical symptoms or opportunistic infections listed in protocol.
- •Written informed consent.
- •If already on zidovudine (AZT) or didanosine (ddI), must have been on this therapy for at least 75 of the 90 days prior to study entry.
- •Prior Medication:
- •Zidovudine (AZT).
- •Didanosine (ddI)
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Major active opportunistic infection requiring active care within 2 weeks of study entry.
- •Evidence of chronic hepatitis with severe liver dysfunction:
- •albumin < 2 g/dl and SGOT or SGPT > 5 x upper limit of normal prothrombin time > 1.5 x upper limit of normal).
- •Other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurologic, or psychiatric disorder.
- •Transfusion dependency defined as requiring > 1 unit of packed red blood cells (RBC) per month within 3 months prior to study entry.
- •Concurrent Medication:
- •Experimental medications other than didanosine (ddI).
- •Chronic prophylactic use of any topical or systemic fungal medication such as ketoconazole, fluconazole, or clotrimazole.
- •Chronic prophylactic use of any topical or systemic anti-viral medication such as acyclovir or ganciclovir except zidovudine (AZT) or didanosine (ddI).
- •Patients with the following are excluded:
- •Asymptomatic at study entry.
- •Presence of antibodies to interferon due to prior therapy.
- •Hospitalization within 2 weeks of study entry.
- •Transfusion dependency.
- •Unwilling or unable to give informed consent.
- •Evidence of any concurrent organ dysfunction listed in Exclusion Co-Existing Conditions.
- •Unlikely or unable to comply with the requirements of the protocol.
- •Prior Medication:
- •Excluded within 6 weeks of study entry:
- •Interferons.
- •Excluded within 45 days of study entry:
- •Immunosuppressive agents.
- •Chemotherapy.
- •Steroids.
- •Immunomodulators.
- •Isoprinosine.
- •BCG vaccine.
- •Prior Treatment:
- •Excluded within 2 weeks of study entry:
- •Hospitalization.
- •Active intravenous (IV) drug abuse.
研究者
研究点 (1)
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