NCT00002013已完成不适用
A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine 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 evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS related complex (ARC).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Zidovudine (AZT).
- •Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
- •Allowed ONLY with permission of the Wyeth-Ayerst medical monitor:
- •Standard therapy for infections that develop during the study period.
- •Oral acyclovir.
- •Nystatin.
- •Ketoconazole.
- •Immunomodulators.
- •Specific therapy for malignancies (including Kaposi's sarcoma).
- •Patients must have the following:
- •Diagnosis of AIDS or AIDS related complex (ARC).
- •Provide informed written consent.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Active opportunistic infection or malignancy requiring treatment at study entry.
- •Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
- •Evidence of central nervous system (CNS) opportunistic infection or malignancy.
- •Serious underlying medical problems, including insulin- dependent diabetes mellitus, unstable ASHD (atherosclerotic heart disease) or uncontrolled hypertension, which may complicate interpretation of treatment results.
- •Dementia.
- •Evidence of = or > 2 + proteinuria at study entry.
- •Concurrent Medication:
- •Excluded without permission of the Wyeth-Ayerst medical monitor:
- •Immunomodulators.
- •Specific therapy for malignancies (including Kaposi's sarcoma).
- •Patients with the following are excluded:
- •Active opportunistic infection or malignancy requiring treatment at study entry.
- •Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
- •Evidence of conditions listed in the Patient Exclusion Co-existing Conditions.
- •Active substance abuse.
- •Unlikely or unable to comply with the requirements of the protocol.
- •Prior Medication:
- •Excluded within 8 weeks of study entry:
- •Immunomodulators.
- •Antiviral therapy, except zidovudine.
- •Excluded within 2 weeks of study entry:
- •Intravenous or oral acyclovir.
- •Excluded within 3 months of study entry:
- •Ribavirin.
- •Zidovudine at a dose of = or > 1000 mg/day for at least 6 weeks prior to study entry.
- •Active substance abuse.
研究者
研究点 (1)
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