A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 566
- 主要终点
- Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
研究概览
简要总结
This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.
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
- •Participant is a male or female at least 18 years of age
- •Participant is HIV positive
- •Participant is naïve to antiretroviral therapy (ART) and has not received any ART
排除标准
- •Participant has received approved or experimental antiretroviral agents in the past
- •Participant has been treated for a viral infection other than HIV such as hepatitis B virus infection with an agent that is active against HIV including but not limited to adefovir or lamivudine (= 7 days total)
- •Participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz
- •Participant has used another experimental HIV-integrase inhibitor
- •Participant has a current (active) diagnosis of acute hepatitis due to any cause
- •Participants with chronic hepatitis including chronic hepatitis B and/or C may enter the study as long as they have stable liver function tests
研究组 & 干预措施
MK-0518 400 mg b.i.d.
MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
干预措施: MK-0518 (Drug)
结局指标
主要结局
Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
时间窗: 48 Weeks
Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 48.
Number of Participants With Serious CAEs at Week 48
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.
Number of Participants That Died by Week 48
时间窗: 48 Weeks
All participant deaths in the span of 48 weeks on study were recorded.
Number of Participants That Discontinued With CAEs at Week 48
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 study drug, whether or not considered related to the use of the product.
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48
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 study drug, whether or not considered related to the use of the product.
Number of Participants With Drug-related CAEs at Week 48
时间窗: 48 Weeks
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants With Serious Drug-related CAEs at Week 48
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. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants That Discontinued With Drug-related CAEs at Week 48
时间窗: 48 Weeks
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48
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. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants That Discontinued With Serious CAEs at Week 48
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.
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48
时间窗: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Number of Participants Discontinued With LAEs at Week 48
时间窗: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Number of Participants With Serious LAEs at Week 48
时间窗: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs 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 Serious Drug-related LAEs at Week 48
时间窗: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs 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. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants With Drug-related LAEs at Week 48
时间窗: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants Discontinued With Drug-related LAEs at Week 48
时间窗: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse events (AEs) in this study were defined as "drug-related" if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone.
次要结局
- Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48(48 Weeks)
- Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96(96 Weeks)
- Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48(Baseline and Week 48)
- Change From Baseline in CD4 Cell Count at Week 96(Baseline and Week 96)
- Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240(240 Weeks)
- Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240(240 Weeks)
- Change From Baseline in CD4 Cell Count at Week 240(Baseline and Week 240)
- Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8(8 Weeks)
- Number of Participants With CAEs at Week 96(96 Weeks)
- Number of Participants With CAEs at Week 156(156 Weeks)
- Number of Participants With CAEs at Week 240(240 Weeks)
- Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96(96 Weeks)
- Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156(156 Weeks)
- Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156(156 Weeks)
- Change From Baseline in CD4 Cell Count at Week 156(Baseline and Week 156)
- Number of Participants With Serious CAEs at Week 96(96 Weeks)
- Number of Participants With Serious CAEs at Week 156(156 Weeks)
- Number of Participants With Serious CAEs at Week 240(240 Weeks)
- Number of Participants With Drug-related CAEs at Week 96(96 Weeks)
- Number of Participants With Drug-related CAEs at Week 156(156 Weeks)
- Number of Participants With Drug-related CAEs at Week 240(240 Weeks)
- Number of Participants With Serious Drug-related CAEs at Week 96(96 Weeks)
- Number of Participants With Serious Drug-related CAEs at Week 156(156 Weeks)
- Number of Participants With Serious Drug-related CAEs at Week 240(240 Weeks)
- Number of Participants That Died by Week 96(96 Weeks)
- Number of Participants That Died by Week 156(156 Weeks)
- Number of Participants That Died by Week 240(240 Weeks)
- Number of Participants That Discontinued With CAEs at Week 96(96 Weeks)
- Number of Participants That Discontinued With CAEs at Week 156(156 Weeks)
- Number of Participants That Discontinued With CAEs at Week 240(240 Weeks)
- Number of Participants That Discontinued With Drug-related CAEs at Week 96(96 Weeks)
- Number of Participants That Discontinued With Drug-related CAEs at Week 156(156 Weeks)
- Number of Participants That Discontinued With Drug-related CAEs at Week 240(240 Weeks)
- Number of Participants That Discontinued With Serious CAEs at Week 96(96 Weeks)
- Number of Participants That Discontinued With Serious CAEs at Week 156(156 Weeks)
- Number of Participants That Discontinued With Serious CAEs at Week 240(240 Weeks)
- Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96(96 Weeks)
- Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156(156 Weeks)
- Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240(240 Weeks)
- Number of Participants With LAEs at Week 96(96 Weeks)
- Number of Participants With LAEs at Week 156(156 Weeks)
- Number of Participants With LAEs at Week 240(240 Weeks)
- Number of Participants With Drug-related LAEs at Week 96(96 Weeks)
- Number of Participants With Drug-related LAEs at Week 156(156 Weeks)
- Number of Participants With Drug-related LAEs at Week 240(240 Weeks)
- Number of Participants With Serious LAEs at Week 96(96 Weeks)
- Number of Participants With Serious LAEs at Week 156(156 Weeks)
- Number of Participants With Serious LAEs at Week 240(240 Weeks)
- Number of Participants With Serious Drug-related LAEs at Week 96(96 Weeks)
- Number of Participants With Serious Drug-related LAEs at Week 156(156 Weeks)
- Number of Participants With Serious Drug-related LAEs at Week 240(240 Weeks)
- Number of Participants Discontinued With LAEs at Week 96(96 Weeks)
- Number of Participants Discontinued With LAEs at Week 156(156 Weeks)
- Number of Participants Discontinued With LAEs at Week 240(240 Weeks)
- Number of Participants Discontinued With Drug-related LAEs at Week 96(96 Weeks)
- Number of Participants Discontinued With Drug-related LAEs at Week 156(156 Weeks)
- Number of Participants Discontinued With Drug-related LAEs at Week 240(240 Weeks)