NCT00002266已完成不适用
An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
Wyeth is now a wholly owned subsidiary of Pfizer1 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
- 1
研究概览
简要总结
To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or AIDS related complex (ARC) patients.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Standard therapy for infections.
- •Acyclovir.
- •Ganciclovir.
- •Allowed only with permission of Wyeth-Ayerst medical monitor:
- •Zidovudine (AZT).
- •Immunomodulators.
- •Specific therapy for malignancies (including Kaposi's sarcoma).
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Evidence of severe liver dysfunction (serum albumin < 3 g/dl, SGOT or SGPT > 5 x upper limit of normal, prothrombin time > 15 seconds), or gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorder other than abnormalities secondary to AIDS or AIDS related complex (ARC).
- •Evidence of AIDS-related central nervous system involvement.
- •Disseminated Kaposi's sarcoma.
- •Concurrent Medication:
- •Excluded without permission of Wyeth-Ayerst medical monitor:
- •Zidovudine (AZT).
- •Immunomodulators.
- •Specific therapy for malignancies (including Kaposi's sarcoma).
- •Patients with the following are excluded:
- •Evidence of major system abnormalities other than abnormalities secondary to AIDS or AIDS related complex.
- •Concomitant conditions as specified in Patient Exclusion Co-existing Conditions.
- •Unlikely or unable to comply with the requirements of the protocol.
- •Prior Medication:
- •Excluded within 4 weeks of study entry:
- •Systemic antiviral agents.
- •Immunosuppressive agents.
- •Immune stimulators such as BCG vaccine, isoprinosine, or other immunomodulators.
- •Patients must:
- •Have a diagnosis of AIDS or AIDS related complex (ARC).
- •Demonstrate intolerance or refusal to take zidovudine (AZT).
- •Provide written informed consent.
研究者
研究点 (1)
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