A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiviral Therapies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 352
- 主要终点
- Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
研究概览
简要总结
This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy with 3-class antiviral resistance.
详细描述
The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be HIV positive with HIV RNA values that are within ranges required by the study
- •Patient must have documented failure of certain antiretroviral therapy
- •Patient must be on the same antiretroviral therapy for at least the past two months
排除标准
- •Patient is less than 16 years old
- •Additional study criteria will be discussed and identified by the study doctor
研究组 & 干预措施
1
raltegravir potassium
干预措施: raltegravir potassium (Drug)
结局指标
主要结局
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
时间窗: 16 Weeks
Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 16
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL
时间窗: 156 Weeks
Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 156
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL
时间窗: 240 Weeks
Percentage of participants who achieved HIV RNA \<400 Copies/mL at Week 240
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48
时间窗: 48 Weeks
Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 48
次要结局
- Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48(48 Weeks)
- Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL(156 weeks)
- Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)(Baseline and Week 156)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16(Baseline and Week 16)
- Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL(240 weeks)
- Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16(16 Weeks)
- Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response(156 weeks)
- Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48(Baseline and Week 48)
- Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)(Baseline and Week 240)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48(Baseline and Week 48)
- Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)(Baseline and Week 156)
- Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)(Baseline and Week 240)