NCT00385645已完成4 期
Comparison of 2 Alternative Antiretroviral Combinations in HIV Post-exposure Prophylaxis: AZT-3TC (Combivir®) + Lopinavir-ritonavir (Kaletra®) Versus AZT-3TC (Combivir®)+ Atazanavir (Reyataz®). Multicentre, Prospective, Randomized, Open Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 14
- 主要终点
- Proportions of patients completing 28-day antiretroviral treatment (ARVT)
研究概览
简要总结
The study compares the adherence of 240 HIV-negative subjects randomly assigned to 2 different antiretroviral therapies for 28 days after accidental exposure to HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age > 18
- •HIV exposure requiring prophylaxis under current guidelines
排除标准
- •Pregnancy
- •Suspected drug resistance in source case
- •Contraindications to the study drugs
结局指标
主要结局
Proportions of patients completing 28-day antiretroviral treatment (ARVT)
次要结局
- Proportion of HIV-seropositive at 6 months
- Incidence of adverse effects (clinical and laboratory) during ARVT
- Adherence to ARVT, time to adherence loss.
研究者
研究点 (14)
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