NCT00541463已完成2 期
A Multicenter, Open-Label, Randomized, Study to Compare the Efficacy and Safety of Indinavir 800 mg b.i.d. Plus Ritonavir 100 mg b.i.d. Plus Two NRTIs vs. Nelfinavir 1250 mg b.i.d. Plus Two NRTIs in HIV-1 Seropositive Patients Who Have Failed or Are Intolerant to an NNRTI Containing Regimen
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 330
- 主要终点
- Plasma viral RNA levels will be measured at predetermined time points to determine mean change
研究概览
简要总结
A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) containing treatment.
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
- •At least 18 years of age
- •HIV positive
- •No active heart disease
排除标准
- •Pregnant or breast feeding
- •Unwilling to use birth control or abstinence to prevent pregnancy
- •Received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study
- •Plan to receive NNRTIs while in the study
- •Received therapy which lowers body's ability to fight infection within the past 30 days or while in the study
- •Alcohol or substance abuse
- •Hepatitis
结局指标
主要结局
Plasma viral RNA levels will be measured at predetermined time points to determine mean change
次要结局
- CD4 cell counts will be measured at predetermined time points to determine change from baseline
研究者
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