NCT00004276已完成2 期
Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
National Center for Research Resources (NCRR)0 个研究点目标入组 50 人开始时间: 1990年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
OBJECTIVES: I. Evaluate whether thalidomide modulates toxic host inflammatory responses in patients receiving antitubercular therapy.
II. Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of HIV and mycobacterial infections, and limits progression of HIV immunodeficiency.
III. Evaluate whether thalidomide stimulates immunity in patients with HIV and/or mycobacterial infections.
详细描述
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are stratified by type of infection.
Patients are randomly assigned to oral thalidomide or placebo. Therapy is administered daily for up to 8 weeks, beginning the night before antitubercular treatment is initiated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- 是
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Human immunodeficiency virus (HIV) or mycobacterial infection that requires at least 10 days of inpatient antitubercular treatment
- •Mycobacterial infection confirmed by positive acid-fast bacilli smear or culture for Mycobacterium tuberculosis
- •At least 1 of the following signs and symptoms required:
- •Temperature over 38 degrees C on at least 2 occasions within 1 week prior to treatment
- •Weight loss greater than 5 kg
- •Pulmonary involvement in at least 1 lobe on x-ray
- •Night sweats on at least 2 occasions within 1 week prior to treatment
- •-Prior/Concurrent Therapy--
- •Concurrent rifampicin, isoniazid, pyrazinamide, and ethambutol for tuberculosis allowed
- •-Patient Characteristics--
- •No neuropathy and not at risk for neuropathy
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 weeks after study
排除标准
- 未提供
研究者
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