NCT00618176已完成4 期
Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort
Peking Union Medical College1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine whether the three generic nevirapine-based antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •the subjects were HIV-seropositive by standard serum enzyme-linked immunosorbent assay (ELISA) tests and also by Western blot analysis
- •the subjects were antiretroviral drug-naïve
- •a baseline CD4+ T-cell count from 100 to 350 cells/mm3 and a baseline plasma viral load over 500copies/ml
排除标准
- •pregnancy or breastfeeding
- •anticipated nonadherence
- •AIDS-defining illness within 2 weeks of entry
- •white blood cell count less than 2.0×109/L, absolute neutrophil count less than 1.0×109/L, hemoglobin level less than 90g/l, platelet count less than 0.75×1012/L
- •transaminase and alkaline phosphatase level more than 3 times the upper limit of the normal range, bilirubin level more than 2.5times the upper limit of the normal range, serum creatinine level more than 1.5 times the upper limit of the normal range
研究组 & 干预措施
B
Experimental
干预措施: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP) (Drug)
A
Experimental
干预措施: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP) (Drug)
C
Experimental
干预措施: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP) (Drug)
研究者
研究点 (1)
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