Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00369941
First received: August 29, 2006
Last updated: September 1, 2015
Last verified: September 2015
Results First Received: September 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: MK-0518
Drug: Comparator: efavirenz
Drug: Comparator: Truvada
Drug: Comparator: Placebo to MK-0518
Drug: Comparator: Placebo to efavirenz

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Primary therapy period: 14-Sep-2006 to 06-May-2009

Multicenter (67) in the United States (18) and Ex-US (49)


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Participant Flow:   Overall Study
    MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s.
STARTED   282   284 
Treated   281   282 
COMPLETED   210   184 
NOT COMPLETED   72   100 
Never Treated                1                2 
Adverse Event                14                28 
Lack of Efficacy                6                10 
Lost to Follow-up                12                22 
Protocol Violation                5                3 
Withdrawal by Subject                5                18 
Pregnancy                4                2 
Completed, Did Not Enter Extension                5                6 
Moved                11                5 
Treatment with Prohibited Medication                3                1 
Employment Interfered with Study Visits                1                0 
Study Site Terminated                2                0 
Miscellaneous                3                3 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.
Total Total of all reporting groups

Baseline Measures
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s.   Total 
Overall Participants Analyzed 
[Units: Participants]
 281   282   563 
Age 
[Units: Years]
Mean (Full Range)
 38 
 (19 to 67) 
 37 
 (19 to 71) 
 37 
 (19 to 71) 
Gender 
[Units: Participants]
     
Female   54   51   105 
Male   227   231   458 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   116   123   239 
Black   33   23   56 
Asian   36   32   68 
Hispanic   60   67   127 
Others   36   37   73 
Cluster of Differentiation 4 (CD4) Cell Count 
[Units: Cells/mm^3]
Mean (Full Range)
 219 
 (1 to 620) 
 217 
 (4 to 807) 
 218 
 (1 to 807) 
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) 
[Units: Copies/mL]
Geometric Mean (Full Range)
 103205 
 (400 to 750000) 
 106215 
 (4410 to 750000) 
 104702 
 (400 to 750000) 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Measure Description Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48.
Time Frame 48 Weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 280   281 
Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 
[Units: Participants]
 241   230 

No statistical analysis provided for Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48



2.  Primary:   Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48
Measure Description 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.
Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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 (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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 
[Units: Participants]
   
With CAEs   253   272 
Without CAEs   28   10 

No statistical analysis provided for Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48



3.  Primary:   Number of Participants With Serious CAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants With Serious CAEs at Week 48
Measure Description 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.
Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious CAEs at Week 48 
[Units: Participants]
   
With Serious CAEs   28   27 
Without Serious CAEs   253   255 

No statistical analysis provided for Number of Participants With Serious CAEs at Week 48



4.  Primary:   Number of Participants With Drug-related CAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants With Drug-related CAEs at Week 48
Measure Description 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.
Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Drug-related CAEs at Week 48 
[Units: Participants]
   
With Drug-related CAEs   124   217 
Without Drug-related CAEs   157   65 

No statistical analysis provided for Number of Participants With Drug-related CAEs at Week 48



5.  Primary:   Number of Participants With Serious Drug-related CAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants With Serious Drug-related CAEs at Week 48
Measure Description

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.

Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious Drug-related CAEs at Week 48 
[Units: Participants]
   
With Serious Drug-related CAEs   4   5 
Without Serious Drug-related CAEs   277   277 

No statistical analysis provided for Number of Participants With Serious Drug-related CAEs at Week 48



6.  Primary:   Number of Participants That Died by Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants That Died by Week 48
Measure Description All participant deaths in the span of 48 weeks on study were recorded.
Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Died by Week 48 
[Units: Participants]
   
Died   2   0 
Did Not Die   279   282 

No statistical analysis provided for Number of Participants That Died by Week 48



7.  Primary:   Number of Participants That Discontinued With CAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants That Discontinued With CAEs at Week 48
Measure Description 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.
Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With CAEs at Week 48 
[Units: Participants]
   
Discontinued with CAEs   9   17 
Did Not Discontinue with CAEs   272   265 

No statistical analysis provided for Number of Participants That Discontinued With CAEs at Week 48



8.  Primary:   Number of Participants That Discontinued With Serious CAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants That Discontinued With Serious CAEs at Week 48
Measure Description 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.
Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Serious CAEs at Week 48 
[Units: Participants]
   
Discontinued with Serious CAEs   7   4 
Did Not Discontinue with Serious CAEs   274   278 

No statistical analysis provided for Number of Participants That Discontinued With Serious CAEs at Week 48



9.  Primary:   Number of Participants That Discontinued With Drug-related CAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants That Discontinued With Drug-related CAEs at Week 48
Measure Description 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.
Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Drug-related CAEs at Week 48 
[Units: Participants]
   
Discontinued with Drug-related CAEs   3   11 
Did not Discontinue with Drug-related CAEs   278   271 

No statistical analysis provided for Number of Participants That Discontinued With Drug-related CAEs at Week 48



10.  Primary:   Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48
Measure Description

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.

Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 
[Units: Participants]
   
Discontiued with Serious Drug-related CAEs   1   2 
Did Not Discontinue with Serious Drug-related CAEs   280   280 

No statistical analysis provided for Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48



11.  Primary:   Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48
Measure Description 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.
Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 
[Units: Participants]
   
With LAEs   27   41 
Without LAEs   254   241 

No statistical analysis provided for Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48



12.  Primary:   Number of Participants With Serious LAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants With Serious LAEs at Week 48
Measure Description

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.

Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious LAEs at Week 48 
[Units: Participants]
   
With Serious LAEs   0   1 
Without Serious LAEs   281   281 

No statistical analysis provided for Number of Participants With Serious LAEs at Week 48



13.  Primary:   Number of Participants With Drug-related LAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants With Drug-related LAEs at Week 48
Measure Description

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.

Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Drug-related LAEs at Week 48 
[Units: Participants]
   
With Drug-related LAEs   14   24 
Without Drug-related LAEs   267   258 

No statistical analysis provided for Number of Participants With Drug-related LAEs at Week 48



14.  Primary:   Number of Participants With Serious Drug-related LAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants With Serious Drug-related LAEs at Week 48
Measure Description

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.

Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious Drug-related LAEs at Week 48 
[Units: Participants]
   
With Serious Drug-related LAEs   0   0 
Without Serious Drug-related LAEs   281   282 

No statistical analysis provided for Number of Participants With Serious Drug-related LAEs at Week 48



15.  Primary:   Number of Participants Discontinued With LAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants Discontinued With LAEs at Week 48
Measure Description 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.
Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Discontinued With LAEs at Week 48 
[Units: Participants]
   
Discontinued with LAEs   0   1 
Did Not Discontinue with LAEs   281   281 

No statistical analysis provided for Number of Participants Discontinued With LAEs at Week 48



16.  Primary:   Number of Participants Discontinued With Drug-related LAEs at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Number of Participants Discontinued With Drug-related LAEs at Week 48
Measure Description

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.

Time Frame 48 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Discontinued With Drug-related LAEs at Week 48 
[Units: Participants]
   
Discontinued with Drug-related LAEs   0   1 
Did Not Discontinue with Drug-related LAEs   281   281 

No statistical analysis provided for Number of Participants Discontinued With Drug-related LAEs at Week 48



17.  Secondary:   Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
Measure Description Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48.
Time Frame 48 Weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had HIV RNA tests performed were included in this analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 280   281 
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 
[Units: Participants]
 252   241 

No statistical analysis provided for Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48



18.  Secondary:   Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48   [ Time Frame: Baseline and Week 48 ]

Measure Type Secondary
Measure Title Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48
Measure Description Mean change from baseline at Week 48 in CD4 cell count (cells/mm3)
Time Frame Baseline and Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 258   251 
Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48 
[Units: CD4 Cell Count (cells/mm3)]
Mean (95% Confidence Interval)
 189.1 
 (173.9 to 204.3) 
 163.3 
 (148.2 to 178.4) 

No statistical analysis provided for Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48



19.  Secondary:   Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96
Measure Description Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96.
Time Frame 96 Weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96 
[Units: Participants]
 228   222 

No statistical analysis provided for Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96



20.  Secondary:   Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96
Measure Description Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96.
Time Frame 96 Weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96 
[Units: Participants]
 240   229 

No statistical analysis provided for Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96



21.  Secondary:   Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline and Week 96 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4 Cell Count at Week 96
Measure Description Mean change from baseline at Week 96 in CD4 cell count (cells/mm3)
Time Frame Baseline and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 249   243 
Change From Baseline in CD4 Cell Count at Week 96 
[Units: CD4 Cell Count (cells/mm3)]
Mean (95% Confidence Interval)
 239.6 
 (219.8 to 259.4) 
 224.8 
 (205.8 to 243.9) 

No statistical analysis provided for Change From Baseline in CD4 Cell Count at Week 96



22.  Secondary:   Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156
Measure Description Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156.
Time Frame 156 Weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156 
[Units: Participants]
 212   192 

No statistical analysis provided for Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156



23.  Secondary:   Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156
Measure Description Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156.
Time Frame 156 Weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156 
[Units: Participants]
 224   203 

No statistical analysis provided for Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156



24.  Secondary:   Change From Baseline in CD4 Cell Count at Week 156   [ Time Frame: Baseline and Week 156 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4 Cell Count at Week 156
Measure Description Mean change from baseline at Week 156 in CD4 cell count (cells/mm3)
Time Frame Baseline and Week 156  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 236   226 
Change From Baseline in CD4 Cell Count at Week 156 
[Units: CD4 Cell Count (cells/mm3)]
Mean (95% Confidence Interval)
 331.7 
 (309.3 to 354.2) 
 295.2 
 (271.3 to 319.0) 

No statistical analysis provided for Change From Baseline in CD4 Cell Count at Week 156



25.  Secondary:   Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240
Measure Description Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240.
Time Frame 240 Weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 279   279 
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240 
[Units: Participants]
 198   171 

No statistical analysis provided for Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240



26.  Secondary:   Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240
Measure Description Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240.
Time Frame 240 Weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 279   279 
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240 
[Units: Participants]
 206   181 

No statistical analysis provided for Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240



27.  Secondary:   Change From Baseline in CD4 Cell Count at Week 240   [ Time Frame: Baseline and Week 240 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4 Cell Count at Week 240
Measure Description Mean change from baseline at Week 240 in CD4 cell count (cells/mm3)
Time Frame Baseline and Week 240  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 222   212 
Change From Baseline in CD4 Cell Count at Week 240 
[Units: CD4 Cell Count (cells/mm3)]
Mean (95% Confidence Interval)
 373.7 
 (344.6 to 402.8) 
 311.6 
 (283.9 to 339.4) 

No statistical analysis provided for Change From Baseline in CD4 Cell Count at Week 240



28.  Secondary:   Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8   [ Time Frame: 8 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8
Measure Description 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
Time Frame 8 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 
[Units: Participants]
   
With Nervous System Symptoms   57   147 
Without Nervous System Symptoms   224   135 

No statistical analysis provided for Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8



29.  Secondary:   Number of Participants With CAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With CAEs at Week 96
Measure Description 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.
Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With CAEs at Week 96 
[Units: Participants]
   
With CAEs   265   274 
Without CAEs   16   8 

No statistical analysis provided for Number of Participants With CAEs at Week 96



30.  Secondary:   Number of Participants With CAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With CAEs at Week 156
Measure Description 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.
Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With CAEs at Week 156 
[Units: Participants]
   
With CAEs   267   276 
Without CAEs   14   6 

No statistical analysis provided for Number of Participants With CAEs at Week 156



31.  Secondary:   Number of Participants With CAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With CAEs at Week 240
Measure Description 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.
Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With CAEs at Week 240 
[Units: Participants]
   
With CAEs   271   276 
Without CAEs   10   6 

No statistical analysis provided for Number of Participants With CAEs at Week 240



32.  Secondary:   Number of Participants With Serious CAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious CAEs at Week 96
Measure Description 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.
Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious CAEs at Week 96 
[Units: Participants]
   
With Serious CAEs   37   33 
Without Serious CAEs   244   249 

No statistical analysis provided for Number of Participants With Serious CAEs at Week 96



33.  Secondary:   Number of Participants With Serious CAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious CAEs at Week 156
Measure Description 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.
Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious CAEs at Week 156 
[Units: Participants]
   
With Serious CAEs   46   46 
Without Serious CAEs   235   236 

No statistical analysis provided for Number of Participants With Serious CAEs at Week 156



34.  Secondary:   Number of Participants With Serious CAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious CAEs at Week 240
Measure Description 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.
Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious CAEs at Week 240 
[Units: Participants]
   
With Serious CAEs   57   57 
Without Serious CAEs   224   225 

No statistical analysis provided for Number of Participants With Serious CAEs at Week 240



35.  Secondary:   Number of Participants With Drug-related CAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Drug-related CAEs at Week 96
Measure Description 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.
Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Drug-related CAEs at Week 96 
[Units: Participants]
   
With drug-related CAEs   132   220 
Without drug-related CAEs   149   62 

No statistical analysis provided for Number of Participants With Drug-related CAEs at Week 96



36.  Secondary:   Number of Participants With Drug-related CAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Drug-related CAEs at Week 156
Measure Description 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.
Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Drug-related CAEs at Week 156 
[Units: Participants]
   
With drug-related CAEs   139   225 
Without drug-related CAEs   142   57 

No statistical analysis provided for Number of Participants With Drug-related CAEs at Week 156



37.  Secondary:   Number of Participants With Drug-related CAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Drug-related CAEs at Week 240
Measure Description 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.
Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Drug-related CAEs at Week 240 
[Units: Participants]
   
With drug-related CAEs   146   226 
Without drug-related CAEs   135   56 

No statistical analysis provided for Number of Participants With Drug-related CAEs at Week 240



38.  Secondary:   Number of Participants With Serious Drug-related CAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious Drug-related CAEs at Week 96
Measure Description

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.

Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious Drug-related CAEs at Week 96 
[Units: Participants]
   
With Serious Drug-related CAEs   6   5 
Without Serious Drug-related CAEs   275   277 

No statistical analysis provided for Number of Participants With Serious Drug-related CAEs at Week 96



39.  Secondary:   Number of Participants With Serious Drug-related CAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious Drug-related CAEs at Week 156
Measure Description

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.

Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious Drug-related CAEs at Week 156 
[Units: Participants]
   
With Serious Drug-related CAEs   6   6 
Without Serious Drug-related CAEs   275   276 

No statistical analysis provided for Number of Participants With Serious Drug-related CAEs at Week 156



40.  Secondary:   Number of Participants With Serious Drug-related CAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious Drug-related CAEs at Week 240
Measure Description

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.

Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious Drug-related CAEs at Week 240 
[Units: Participants]
   
With Serious Drug-related CAEs   8   7 
Without Serious Drug-related CAEs   273   275 

No statistical analysis provided for Number of Participants With Serious Drug-related CAEs at Week 240



41.  Secondary:   Number of Participants That Died by Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Died by Week 96
Measure Description All participant deaths in the span of 96 weeks on study were recorded.
Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Died by Week 96 
[Units: Participants]
   
Died   3   0 
Did Not Die   278   282 

No statistical analysis provided for Number of Participants That Died by Week 96



42.  Secondary:   Number of Participants That Died by Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Died by Week 156
Measure Description All participant deaths in the span of 156 weeks on study were recorded.
Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Died by Week 156 
[Units: Participants]
   
Died   4   1 
Did Not Die   277   281 

No statistical analysis provided for Number of Participants That Died by Week 156



43.  Secondary:   Number of Participants That Died by Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Died by Week 240
Measure Description All participant deaths in the span of 240 weeks on study were recorded.
Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Died by Week 240 
[Units: Participants]
   
Died   5   5 
Did Not Die   276   277 

No statistical analysis provided for Number of Participants That Died by Week 240



44.  Secondary:   Number of Participants That Discontinued With CAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With CAEs at Week 96
Measure Description 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.
Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With CAEs at Week 96 
[Units: Participants]
   
Discontinued With CAEs   10   17 
Did Not Discontinue With CAEs   271   265 

No statistical analysis provided for Number of Participants That Discontinued With CAEs at Week 96



45.  Secondary:   Number of Participants That Discontinued With CAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With CAEs at Week 156
Measure Description 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.
Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With CAEs at Week 156 
[Units: Participants]
   
Discontinued With CAEs   13   21 
Did Not Discontinue With CAEs   268   261 

No statistical analysis provided for Number of Participants That Discontinued With CAEs at Week 156



46.  Secondary:   Number of Participants That Discontinued With CAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With CAEs at Week 240
Measure Description 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.
Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With CAEs at Week 240 
[Units: Participants]
   
Discontinued With CAEs   14   25 
Did Not Discontinue With CAEs   267   257 

No statistical analysis provided for Number of Participants That Discontinued With CAEs at Week 240



47.  Secondary:   Number of Participants That Discontinued With Drug-related CAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With Drug-related CAEs at Week 96
Measure Description 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.
Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Drug-related CAEs at Week 96 
[Units: Participants]
   
Discontinued With Drug-Related CAEs   3   12 
Did Not Discontinue With Drug-Related CAEs   278   270 

No statistical analysis provided for Number of Participants That Discontinued With Drug-related CAEs at Week 96



48.  Secondary:   Number of Participants That Discontinued With Drug-related CAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With Drug-related CAEs at Week 156
Measure Description 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.
Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Drug-related CAEs at Week 156 
[Units: Participants]
   
Discontinued With Drug-related CAEs   3   14 
Did Not Discontinue With Drug-related CAEs   278   268 

No statistical analysis provided for Number of Participants That Discontinued With Drug-related CAEs at Week 156



49.  Secondary:   Number of Participants That Discontinued With Drug-related CAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With Drug-related CAEs at Week 240
Measure Description 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.
Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Drug-related CAEs at Week 240 
[Units: Participants]
   
Discontinued With Drug-related CAEs   3   14 
Did Not Discontinue With Drug-related CAEs   278   268 

No statistical analysis provided for Number of Participants That Discontinued With Drug-related CAEs at Week 240



50.  Secondary:   Number of Participants That Discontinued With Serious CAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With Serious CAEs at Week 96
Measure Description 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.
Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Serious CAEs at Week 96 
[Units: Participants]
   
Discontinued With Serious CAEs   8   5 
Did Not Discontinue With Serious CAEs   273   277 

No statistical analysis provided for Number of Participants That Discontinued With Serious CAEs at Week 96



51.  Secondary:   Number of Participants That Discontinued With Serious CAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With Serious CAEs at Week 156
Measure Description 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.
Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Serious CAEs at Week 156 
[Units: Participants]
   
Discontinued With Serious CAEs   10   6 
Did Not Discontinue With Serious CAEs   271   276 

No statistical analysis provided for Number of Participants That Discontinued With Serious CAEs at Week 156



52.  Secondary:   Number of Participants That Discontinued With Serious CAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With Serious CAEs at Week 240
Measure Description 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.
Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Serious CAEs at Week 240 
[Units: Participants]
   
Discontinued With Serious CAEs   11   10 
Did Not Discontinue With Serious CAEs   270   272 

No statistical analysis provided for Number of Participants That Discontinued With Serious CAEs at Week 240



53.  Secondary:   Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96
Measure Description

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.

Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 
[Units: Participants]
   
Discontinued With Serious Drug-related CAEs   1   2 
Did Not Discontinue With Serious Drug-related CAEs   280   280 

No statistical analysis provided for Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96



54.  Secondary:   Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156
Measure Description

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.

Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 
[Units: Participants]
   
Discontinued With Serious Drug-related CAEs   1   2 
Did Not Discontinue With Serious Drug-related CAEs   280   280 

No statistical analysis provided for Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156



55.  Secondary:   Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240
Measure Description

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.

Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 
[Units: Participants]
   
Discontinued With Serious Drug-related CAEs   1   2 
Did Not Discontinue With Serious Drug-related CAEs   280   280 

No statistical analysis provided for Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240



56.  Secondary:   Number of Participants With LAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With LAEs at Week 96
Measure Description 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.
Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With LAEs at Week 96 
[Units: Participants]
   
With LAEs   33   53 
Without LAEs   248   229 

No statistical analysis provided for Number of Participants With LAEs at Week 96



57.  Secondary:   Number of Participants With LAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With LAEs at Week 156
Measure Description 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.
Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With LAEs at Week 156 
[Units: Participants]
   
With LAEs   41   63 
Without LAEs   240   219 

No statistical analysis provided for Number of Participants With LAEs at Week 156



58.  Secondary:   Number of Participants With LAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With LAEs at Week 240
Measure Description 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.
Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With LAEs at Week 240 
[Units: Participants]
   
With LAEs   56   77 
Without LAEs   225   205 

No statistical analysis provided for Number of Participants With LAEs at Week 240



59.  Secondary:   Number of Participants With Drug-related LAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Drug-related LAEs at Week 96
Measure Description

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.

Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Drug-related LAEs at Week 96 
[Units: Participants]
   
With Drug-related LAEs   18   29 
Without Drug-related LAEs   263   253 

No statistical analysis provided for Number of Participants With Drug-related LAEs at Week 96



60.  Secondary:   Number of Participants With Drug-related LAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Drug-related LAEs at Week 156
Measure Description

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.

Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Drug-related LAEs at Week 156 
[Units: Participants]
   
With Drug-related LAEs   22   33 
Without Drug-related LAEs   259   249 

No statistical analysis provided for Number of Participants With Drug-related LAEs at Week 156



61.  Secondary:   Number of Participants With Drug-related LAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Drug-related LAEs at Week 240
Measure Description

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.

Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Drug-related LAEs at Week 240 
[Units: Participants]
   
With Drug-related LAEs   26   43 
Without Drug-related LAEs   255   239 

No statistical analysis provided for Number of Participants With Drug-related LAEs at Week 240



62.  Secondary:   Number of Participants With Serious LAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious LAEs at Week 96
Measure Description

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.

Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious LAEs at Week 96 
[Units: Participants]
   
With Serious LAEs   0   1 
Without Serious LAEs   281   281 

No statistical analysis provided for Number of Participants With Serious LAEs at Week 96



63.  Secondary:   Number of Participants With Serious LAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious LAEs at Week 156
Measure Description

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.

Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious LAEs at Week 156 
[Units: Participants]
   
With Serious LAEs   0   2 
Without Serious LAEs   281   280 

No statistical analysis provided for Number of Participants With Serious LAEs at Week 156



64.  Secondary:   Number of Participants With Serious LAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious LAEs at Week 240
Measure Description

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.

Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious LAEs at Week 240 
[Units: Participants]
   
With Serious LAEs   0   2 
Without Serious LAEs   281   280 

No statistical analysis provided for Number of Participants With Serious LAEs at Week 240



65.  Secondary:   Number of Participants With Serious Drug-related LAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious Drug-related LAEs at Week 96
Measure Description

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.

Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious Drug-related LAEs at Week 96 
[Units: Participants]
   
With Serious Drug-related CAEs   0   0 
Without Serious Drug-related CAEs   281   282 

No statistical analysis provided for Number of Participants With Serious Drug-related LAEs at Week 96



66.  Secondary:   Number of Participants With Serious Drug-related LAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious Drug-related LAEs at Week 156
Measure Description

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.

Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious Drug-related LAEs at Week 156 
[Units: Participants]
   
With Serious Drug-related CAEs   0   1 
Without Serious Drug-related CAEs   281   281 

No statistical analysis provided for Number of Participants With Serious Drug-related LAEs at Week 156



67.  Secondary:   Number of Participants With Serious Drug-related LAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Serious Drug-related LAEs at Week 240
Measure Description

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.

Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants With Serious Drug-related LAEs at Week 240 
[Units: Participants]
   
With Serious Drug-related LAEs   0   1 
Without Serious Drug-related LAEs   281   281 

No statistical analysis provided for Number of Participants With Serious Drug-related LAEs at Week 240



68.  Secondary:   Number of Participants Discontinued With LAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Discontinued With LAEs at Week 96
Measure Description 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.
Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Discontinued With LAEs at Week 96 
[Units: Participants]
   
Discontinued With LAEs   0   2 
Did Not Discontinue With LAEs   281   280 

No statistical analysis provided for Number of Participants Discontinued With LAEs at Week 96



69.  Secondary:   Number of Participants Discontinued With LAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Discontinued With LAEs at Week 156
Measure Description 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.
Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Discontinued With LAEs at Week 156 
[Units: Participants]
   
Discontinued With LAEs   0   3 
Did Not Discontinue With LAEs   281   279 

No statistical analysis provided for Number of Participants Discontinued With LAEs at Week 156



70.  Secondary:   Number of Participants Discontinued With LAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Discontinued With LAEs at Week 240
Measure Description 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.
Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Discontinued With LAEs at Week 240 
[Units: Participants]
   
Discontinued With LAEs   0   3 
Did Not Discontinue With LAEs   281   279 

No statistical analysis provided for Number of Participants Discontinued With LAEs at Week 240



71.  Secondary:   Number of Participants Discontinued With Drug-related LAEs at Week 96   [ Time Frame: 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Discontinued With Drug-related LAEs at Week 96
Measure Description

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.

Time Frame 96 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Discontinued With Drug-related LAEs at Week 96 
[Units: Participants]
   
Discontinued With Drug-related LAEs   0   1 
Did Not Discontinue With Drug-related LAEs   281   281 

No statistical analysis provided for Number of Participants Discontinued With Drug-related LAEs at Week 96



72.  Secondary:   Number of Participants Discontinued With Drug-related LAEs at Week 156   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Discontinued With Drug-related LAEs at Week 156
Measure Description

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.

Time Frame 156 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Discontinued With Drug-related LAEs at Week 156 
[Units: Participants]
   
Discontinued With Drug-related LAEs   0   2 
Did Not Discontinue With Drug-related LAEs   281   280 

No statistical analysis provided for Number of Participants Discontinued With Drug-related LAEs at Week 156



73.  Secondary:   Number of Participants Discontinued With Drug-related LAEs at Week 240   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Number of Participants Discontinued With Drug-related LAEs at Week 240
Measure Description

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.

Time Frame 240 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who took study medication and had any laboratory tests performed were included in the analysis.

Reporting Groups
  Description
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.
Efavirenz 600 mg q.h.s. 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.

Measured Values
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s. 
Participants Analyzed 
[Units: Participants]
 281   282 
Number of Participants Discontinued With Drug-related LAEs at Week 240 
[Units: Participants]
   
Discontinued With Drug-related LAEs   0   2 
Did Not Discontinue With Drug-related LAEs   281   280 

No statistical analysis provided for Number of Participants Discontinued With Drug-related LAEs at Week 240




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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