NCT00386659终止4 期
A Randomized, Pilot Study on the Antiviral Activity and Immunological Effects of Lopinavir/Ritonavir vs. Efavirenz in Treatment-naïve HIV-Infected Patients With CD4 Cell Counts Below 100 Cells/mm3
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.
研究概览
简要总结
Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.
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
- •HIV-infection
- •Antiretroviral-naive
- •CD4 cell count below 100 cells/mm3
排除标准
- •Pregnancy
- •Current opportunistic infection requiring parenteral therapy
- •Current malignancies requiring parenteral chemotherapy
- •Any contraindication to the study drugs
结局指标
主要结局
Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.
次要结局
- New CDC C events
- Mortality
- Degree and kinetics of recovery of the immune system.
研究者
研究点 (8)
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