NCT00002104已完成1 期
Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
To demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam, and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. To demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis lesions, and immune responses.
详细描述
Patients are randomized to receive thalidomide or placebo orally at 9 PM the night before beginning anti-tuberculosis chemotherapy and continuing nightly for 7 nights. Patients are followed for 28 days. Patients are stratified according to HIV status and stage of HIV infection.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Positive AFB smear and/or culture for Mycobacterium tuberculosis, M. avium, or other mycobacterial infection, with or without documented HIV infection. NOTE:
- •HIV-positive patients must have CD4 count < 500 cells/mm3 and be on antiretroviral therapy.
- •One of the following manifestations:
- •Temperature over 38 C on at least two occasions in the week prior to study entry.
- •Recent weight loss of more than 5 kilograms.
- •Pulmonary involvement of one or more lobes or involvement of other tissues due to tuberculosis or other mycobacterial infections, or symptomatic infections related to HIV status.
- •Night sweats on two or more occasions in the week prior to study entry.
- •Patients must be hospitalized men aged 18-65 and postmenopausal women to age
- •Anticipated requirement for hospitalization must be at least 10 days.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Neuropathy or other disorders with risk of neuropathy.
- •Required for HIV-positive patients if CD4 count < 500 cells/mm3:
- •Antiretroviral therapy.
研究者
研究点 (2)
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