A Phase III Open-Label Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of MK0518/Raltegravir in a Diverse Cohort of HIV-Infected Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 209
- 主要终点
- Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
研究概览
简要总结
A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is HIV positive
- •Patient agrees to use (or have their partner use) birth control as defined by the study doctor
排除标准
- •If female, pregnant or breastfeeding
- •Patient has used an investigational agent in the last 30 days
- •Patient has acute hepatitis
- •Patient has received MK0518 (raltegravir) before
- •Patient has used another experimental HIV-integrase inhibitor
结局指标
主要结局
Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
时间窗: Week 48
Numbers of participants with HIV RNA copies \<50 copies/mL were summarized by race for each time point.
Number of Participants With One or More Adverse Events
时间窗: Week 48
Numbers of participants with one or more adverse events were summarized by race.
Number of Participants Who Discontinued Due to an Adverse Event
时间窗: Week 48
Numbers of participants who discontinued due to an adverse event were summarized by race.
次要结局
- Mean Change From Baseline to Week 48 in CD4 Cell Count(Baseline and Week 48)
- Number of Participants Without Loss of Virologic Response(Week 48)
- Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48(Week 48)
- Mean Change From Baseline to Week 48 in HIV RNA(Baseline and Week 48)