Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety and Activity of MK0518 Plus Tenofovir and Lamivudine (3TC) Versus Efavirenz Plus Tenofovir and Lamivudine (3TC) in ART-Naive, HIV-Infected Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 206
- 主要终点
- Number of Patients With Serious CAEs (Cohort I and II Combined)
研究概览
简要总结
This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.
详细描述
Participants who completed 48 weeks of the original 48-week double-blind study were invited to continue in two extensions: MK0518-004-10 (NCT00100048), which extended the study to 144 weeks, and MK0518-004-20 (NCT00100048), which extended the study to 240 weeks. Participants who had been randomized to MK0518 in the base study continued at 400 mg MK0518 twice daily.
Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study. The doses of open label tenofovir and lamivudine continued unchanged.
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 who must have received less than 7 days total of any antiretroviral therapy (HIV related therapy)
- •Extension Studies:
- •First extension: Patient completed the 48-week base study
- •Second extension: Patient completed the first 144-week extension study
排除标准
- •Less than 18 years of age
- •Individuals who currently do not test positive for HIV
研究组 & 干预措施
placebo monotherapy
Placebo to MK0518 twice daily
干预措施: Placebo monotherapy (Drug)
结局指标
主要结局
Number of Patients With Serious CAEs (Cohort I and II Combined)
时间窗: 48 weeks
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)
时间窗: Baseline and Day 10
Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)
Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)
时间窗: 10 days
An adverse experience (AE) 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 product, whether or not considered related to the use of the product. Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.
Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)
时间窗: Week 24
Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)
时间窗: Week 240
An AE was defined as any unfavorable \& unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE. A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose.
Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240
时间窗: Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.
Number of Patients With Clinical Adverse Experiences (CAEs)
时间窗: 48 weeks
An adverse experience (AE) 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 product, whether or not considered related to the use of the product.
Number of Patients With Serious CAEs and Non-serious CAEs at Week 144
时间窗: 144 Weeks
An adverse experience (AE) 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 product, whether or not considered related to the use of the product An adverse experience (AE) 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 product, whether or not considered related to the use of the product
次要结局
- Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)(Baseline and Week 24)
- Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)(Week 24)
- Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96(96 Weeks)
- Change From Baseline in CD4 (T-helper) Cell Count at Week 240(Baseline and Week 240)
- Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)(Baseline and Week 24)
- Change From Baseline in Plasma HIV RNA at Week 96(Baseline and Week 96)
- Change From Baseline in CD4 Cell Count at Week 96(Baseline and Week 96)
- Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240(Week 240)
- Change From Baseline in Plasma HIV RNA at Week 240(Baseline and Week 240)