NCT00385957已完成4 期
Comparison of Antiretroviral Activity and Immunological Effect of Two Triple Treatments With and Without Protease Inhibitors in naïve HIV-1-infected Patients With CD4 < 100/mm3
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 12
- 主要终点
- Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.
研究概览
简要总结
The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 < 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).
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
- •Diagnosed HIV-1 infection.
- •Age 18 years or over.
- •No previous antiretroviral therapy.
- •CD4 lymphocyte count of < 100 cells/mL.
- •Patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study.
排除标准
- •Pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period.
- •Currently undergoing treatment for an opportunistic infection (parenteral administration).
- •Any formal contraindication to treatment with the study drugs
结局指标
主要结局
Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.
Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.
次要结局
- Incidence of adverse events
- CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)
- Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive
- and levels of CD8 cells (CD28+ y CD38+)
研究者
研究点 (12)
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