A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus KALETRA in HIV-Infected Patients Switched From a Stable KALETRA-Based Regimen - Study A
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 352
- 主要终点
- Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
研究概览
简要总结
The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV.
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 is at least 18 years of age
- •Patient is Human Immunodeficiency Virus (HIV) positive
- •Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen
- •Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
- •Patient has no documentation of HIV RNA >50 copies/mL for at least 3 months while on the KALETRA based regimen
排除标准
- •Patient is or plans to become pregnant, or nursing a child
- •Patient plans to donate eggs or impregnate/donate sperm
- •Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
- •Patient is currently receiving a second protease inhibitor in addition to KALETRA
- •Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
- •Patient has used another experimental HIV-integrase inhibitor
- •Patient has a current (active) diagnosis of acute hepatitis due to any cause
- •Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study
研究组 & 干预措施
1
Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir )
干预措施: MK0518 (raltegravir) (Drug)
结局指标
主要结局
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
时间窗: Baseline and Week 12
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
时间窗: 24 Week last patient last visit
An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck \& Co., Inc.) product, whether or not considered related to the use of the product
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
时间窗: Baseline and Week 12
Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
时间窗: Week 24
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
时间窗: Baseline and Week 12
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
时间窗: Baseline and Week 12
Median Percent Change From Baseline in Serum Triglyceride at Week 12
时间窗: Baseline and Week 12
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
次要结局
- Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24(Baseline and Week 24)
- Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24(Baseline and Week 24)
- Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24(Baseline and Week 24)
- Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24(Baseline and Week 24)
- Median Percent Change From Baseline in Serum Triglyceride at Week 24(Baseline and Week 24)