A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)

Study Overview
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Brief Summary
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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.

Official Title
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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™

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: MK-0518
* Drug: Comparator: efavirenz
* Drug: Comparator: Truvada
* Drug: Comparator: Placebo to MK-0518
* Drug: Comparator: Placebo to efavirenz


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-0518 400 mg b.i.d.<br>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. | Drug: MK-0518<br>* 400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks<br>* Other names: Isentress®;Drug: Comparator: Truvada<br>* One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)<br>* Other names: emtricitabine/tenofovir disoproxil fumarate;Drug: Comparator: Placebo to efavirenz<br>* Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks<br>|
| Active Comparator: Efavirenz 600 mg q.h.s.<br>Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min. | Drug: Comparator: efavirenz<br>* 600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks<br>* Other names: Sustiva®;Drug: Comparator: Truvada<br>* One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)<br>* Other names: emtricitabine/tenofovir disoproxil fumarate;Drug: Comparator: Placebo to MK-0518<br>* Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 | Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48. | 48 Weeks | 
| Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 | 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. | 48 Weeks | 
| Number of Participants With Serious CAEs at Week 48 | 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. | 48 Weeks | 
| Number of Participants With Drug-related CAEs at Week 48 | 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. | 48 Weeks | 
| Number of Participants With Serious Drug-related CAEs at Week 48 | 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. | 48 Weeks | 
| Number of Participants That Died by Week 48 | All participant deaths in the span of 48 weeks on study were recorded. | 48 Weeks | 
| Number of Participants That Discontinued With CAEs at Week 48 | 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. | 48 Weeks | 
| Number of Participants That Discontinued With Serious CAEs at Week 48 | 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. | 48 Weeks | 
| Number of Participants That Discontinued With Drug-related CAEs at Week 48 | 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. | 48 Weeks | 
| Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 | 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. | 48 Weeks | 
| Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 | 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. | 48 Weeks | 
| Number of Participants With Serious LAEs at Week 48 | 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. | 48 Weeks | 
| Number of Participants With Drug-related LAEs at Week 48 | 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. | 48 Weeks | 
| Number of Participants With Serious Drug-related LAEs at Week 48 | 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. | 48 Weeks | 
| Number of Participants Discontinued With LAEs at Week 48 | 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. | 48 Weeks | 
| Number of Participants Discontinued With Drug-related LAEs at Week 48 | 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. | 48 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 | Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48. | 48 Weeks | 
| Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48 | Mean change from baseline at Week 48 in CD4 cell count (cells/mm3) | Baseline and Week 48 | 
| Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96 | Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96. | 96 Weeks | 
| Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96 | Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96. | 96 Weeks | 
| Change From Baseline in CD4 Cell Count at Week 96 | Mean change from baseline at Week 96 in CD4 cell count (cells/mm3) | Baseline and Week 96 | 
| Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156 | Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156. | 156 Weeks | 
| Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156 | Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156. | 156 Weeks | 
| Change From Baseline in CD4 Cell Count at Week 156 | Mean change from baseline at Week 156 in CD4 cell count (cells/mm3) | Baseline and Week 156 | 
| Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240 | Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240. | 240 Weeks | 
| Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240 | Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240. | 240 Weeks | 
| Change From Baseline in CD4 Cell Count at Week 240 | Mean change from baseline at Week 240 in CD4 cell count (cells/mm3) | Baseline and Week 240 | 
| Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 | Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression | 8 Weeks | 
| Number of Participants With CAEs at Week 96 | An adverse event (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. | 96 Weeks | 
| Number of Participants With CAEs at Week 156 | An adverse event (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. | 156 Weeks | 
| Number of Participants With CAEs at Week 240 | An adverse event (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. | 240 Weeks | 
| Number of Participants With Serious CAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants With Serious CAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants With Serious CAEs at Week 240 | 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. | 240 Weeks | 
| Number of Participants With Drug-related CAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants With Drug-related CAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants With Drug-related CAEs at Week 240 | 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. | 240 Weeks | 
| Number of Participants With Serious Drug-related CAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants With Serious Drug-related CAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants With Serious Drug-related CAEs at Week 240 | 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. | 240 Weeks | 
| Number of Participants That Died by Week 96 | All participant deaths in the span of 96 weeks on study were recorded. | 96 Weeks | 
| Number of Participants That Died by Week 156 | All participant deaths in the span of 156 weeks on study were recorded. | 156 Weeks | 
| Number of Participants That Died by Week 240 | All participant deaths in the span of 240 weeks on study were recorded. | 240 Weeks | 
| Number of Participants That Discontinued With CAEs at Week 96 | An adverse event (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. | 96 Weeks | 
| Number of Participants That Discontinued With CAEs at Week 156 | An adverse event (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. | 156 Weeks | 
| Number of Participants That Discontinued With CAEs at Week 240 | An adverse event (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. | 240 Weeks | 
| Number of Participants That Discontinued With Drug-related CAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants That Discontinued With Drug-related CAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants That Discontinued With Drug-related CAEs at Week 240 | 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. | 240 Weeks | 
| Number of Participants That Discontinued With Serious CAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants That Discontinued With Serious CAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants That Discontinued With Serious CAEs at Week 240 | 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. | 240 Weeks | 
| Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 | 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. | 240 Weeks | 
| Number of Participants With LAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants With LAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants With LAEs at Week 240 | 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. | 240 Weeks | 
| Number of Participants With Drug-related LAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants With Drug-related LAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants With Drug-related LAEs at Week 240 | 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. | 240 Weeks | 
| Number of Participants With Serious LAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants With Serious LAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants With Serious LAEs at Week 240 | 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. | 240 Weeks | 
| Number of Participants With Serious Drug-related LAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants With Serious Drug-related LAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants With Serious Drug-related LAEs at Week 240 | 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. | 240 Weeks | 
| Number of Participants Discontinued With LAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants Discontinued With LAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants Discontinued With LAEs at Week 240 | 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. | 240 Weeks | 
| Number of Participants Discontinued With Drug-related LAEs at Week 96 | 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. | 96 Weeks | 
| Number of Participants Discontinued With Drug-related LAEs at Week 156 | 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. | 156 Weeks | 
| Number of Participants Discontinued With Drug-related LAEs at Week 240 | 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. | 240 Weeks |