NCT00105157已完成2 期
Multicenter Study to Evaluate the Safety and Efficacy of MK0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 179
- 主要终点
- Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
研究概览
简要总结
This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.
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
- Double (Participant, Investigator)
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
- •Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
- •Patient must be currently on antiretroviral therapy (ART)
排除标准
- •Patient less than 18 years of age
- •Additional exclusion criteria will be discussed and identified by the study doctor
研究组 & 干预措施
4
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
3
Experimental
MK0518 600 mg
干预措施: MK0518 (Drug)
2
Experimental
MK0518 400 mg
干预措施: MK0518 (Drug)
结局指标
主要结局
Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
时间窗: Baseline and Week 24
Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients
次要结局
- Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks(168 weeks)
- Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks(96 weeks)
- Number of Patients That Discontinued With CAEs at 168 Weeks(168 weeks)
- Number of Patients Discontinued With LAEs at 168 Weeks(168 weeks)
- Number of Patients With Serious Drug-related CAEs at 48 Weeks(48 weeks)
- Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks(48 weeks)
- Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks(48 weeks)
- Number of Patients Discontinued With Drug-related LAEs at 48 Weeks(48 weeks)
- Number of Patients That Died by 48 Weeks(48 weeks)
- Number of Patients That Discontinued With CAEs at 48 Weeks(48 weeks)
- Change From Baseline in CD4 Cell Count at Week 24(Baseline and Week 24)
- Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks(48 weeks)
- Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks(48 weeks)
- Number of Patients With Serious CAEs at 96 Weeks(96 weeks)
- Number of Patients With Serious Drug-related CAEs at 96 Weeks(96 weeks)
- Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks(168 weeks)
- Number of Patients With Drug-related LAEs at 168 Weeks(168 weeks)
- Number of Patients With Virologic Responses at Week 24(24 weeks)
- Number of Patients With Serious CAEs at 48 Weeks(48 weeks)
- Number of Patients That Discontinued With Serious CAEs at 48 Weeks(48 weeks)
- Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks(48 weeks)
- Number of Patients That Discontinued With Serious CAEs at 96 Weeks(96 weeks)
- Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks(96 weeks)
- Number of Patients With Drug-related CAEs at 168 Weeks(168 weeks)
- Number of Patients That Discontinued With Serious CAEs at 168 Weeks(168 weeks)
- Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks(168 weeks)
- Number of Patients With Drug-related CAEs at 48 Weeks(48 weeks)
- Number of Patients With Drug-related LAEs at 48 Weeks(48 weeks)
- Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks(96 weeks)
- Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks(96 weeks)
- Number of Patients With Drug-related LAEs at 96 Weeks(96 weeks)
- Number of Patients Discontinued With Drug-related LAEs at 96 Weeks(96 weeks)
- Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks(168 weeks)
- Number of Patients With Serious Drug-related CAEs at 168 Weeks(168 weeks)
- Number of Patients Discontinued With Drug-related LAEs at 168 Weeks(168 weeks)
- Number of Patients With Drug-related CAEs at 96 Weeks(96 weeks)
- Number of Patients That Died by 96 Weeks(96 weeks)
- Number of Patients That Discontinued With CAEs at 96 Weeks(96 weeks)
- Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks(96 weeks)
- Number of Patients With Serious CAEs at 168 Weeks(168 weeks)
- Number of Patients That Died by 168 Weeks(168 weeks)
- Number of Patients With Serious LAEs at 168 Weeks(168 weeks)
- Number of Patients With Serious Drug-related LAEs at 168 Weeks(168 weeks)
研究者
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