NCT00002288已完成不适用
Safety and Efficacy of Retrovir in HIV Infected Patients Having Neuropsychological Impairments
Glaxo Wellcome2 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
- 2
研究概览
简要总结
To assess the efficacy of Retrovir (AZT) therapy in the treatment of HIV Ab positive persons with impairments in neuropsychological functioning. To assess the safety, virologic, and immunologic effects of AZT therapy in HIV Ab positive persons with neuropsychological impairment but minimal other symptomatology.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) infections or neoplasms, e.g., toxoplasmosis, primary or metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections.
- •Lymphoma or other tumor requiring cytotoxic chemotherapy.
- •Concurrent Medication:
- •Other antiretroviral agents.
- •Patients with the following are excluded:
- •AIDS or advanced ARC.
- •Neuropsychological (NP) impairments more severe than described above; i.e., defective performance on NP test battery in 3 or more NP areas on the NP screening battery at 2 standard deviations below the mean.
- •Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections.
- •Prior Medication:
- •Antiretroviral agents including zidovudine (AZT).
- •Prior Treatment:
- •Excluded within 3 months of study entry:
- •Blood transfusion.
- •Impaired performance on a defined neuropsychological test battery.
- •Asymptomatic HIV infection.
- •Persistent generalized lymphadenopathy (PGL).
- •Early AIDS related complex (ARC).
- •Seropositive for human immunodeficiency virus (HIV) demonstrated by positive ELISA test and confirmed by Western blot with no or minimal symptomatology or HIV infection.
- •Ability to give informed consent or a person with durable power of attorney who can give informed consent.
- •Willingness to be followed by the originating medical center for 1 year.
- •History of drug or alcohol abuse.
排除标准
- 未提供
研究者
研究点 (2)
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