Trial Outcomes & Findings for 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) (NCT NCT00369941)

Last Updated: 2017-03-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

566 participants

Primary outcome timeframe

48 Weeks

Results posted on

2017-03-21

Participant Flow

Primary therapy period: 14-Sep-2006 to 06-May-2009 Multicenter (67) in the United States (18) and Ex-US (49)

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	282	284
Overall Study Treated	281	282
Overall Study COMPLETED	210	184
Overall Study NOT COMPLETED	72	100

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Never Treated	1	2
Overall Study Adverse Event	14	28
Overall Study Lack of Efficacy	6	10
Overall Study Lost to Follow-up	12	22
Overall Study Protocol Violation	5	3
Overall Study Withdrawal by Subject	5	18
Overall Study Pregnancy	4	2
Overall Study Completed, Did Not Enter Extension	5	6
Overall Study Moved	11	5
Overall Study Treatment with Prohibited Medication	3	1
Overall Study Employment Interfered with Study Visits	1	0
Overall Study Study Site Terminated	2	0
Overall Study Miscellaneous	3	3

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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 n=563 Participants Total of all reporting groups
Age, Continuous	38 years n=5 Participants	37 years n=7 Participants	37 years n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	51 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	227 Participants n=5 Participants	231 Participants n=7 Participants	458 Participants n=5 Participants
Race/Ethnicity, Customized White	116 participants n=5 Participants	123 participants n=7 Participants	239 participants n=5 Participants
Race/Ethnicity, Customized Black	33 participants n=5 Participants	23 participants n=7 Participants	56 participants n=5 Participants
Race/Ethnicity, Customized Asian	36 participants n=5 Participants	32 participants n=7 Participants	68 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	60 participants n=5 Participants	67 participants n=7 Participants	127 participants n=5 Participants
Race/Ethnicity, Customized Others	36 participants n=5 Participants	37 participants n=7 Participants	73 participants n=5 Participants
Cluster of Differentiation 4 (CD4) Cell Count	219 Cells/mm^3 n=5 Participants	217 Cells/mm^3 n=7 Participants	218 Cells/mm^3 n=5 Participants
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA)	103205 Copies/mL n=5 Participants	106215 Copies/mL n=7 Participants	104702 Copies/mL n=5 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 48.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=280 Participants 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. n=281 Participants 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.
Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48	241 Participants	230 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 With CAEs	253 Participants	272 Participants
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 Without CAEs	28 Participants	10 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious CAEs at Week 48 With Serious CAEs	28 Participants	27 Participants
Number of Participants With Serious CAEs at Week 48 Without Serious CAEs	253 Participants	255 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Drug-related CAEs at Week 48 With Drug-related CAEs	124 Participants	217 Participants
Number of Participants With Drug-related CAEs at Week 48 Without Drug-related CAEs	157 Participants	65 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious Drug-related CAEs at Week 48 With Serious Drug-related CAEs	4 Participants	5 Participants
Number of Participants With Serious Drug-related CAEs at Week 48 Without Serious Drug-related CAEs	277 Participants	277 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication were included in the analysis.

All participant deaths in the span of 48 weeks on study were recorded.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Died by Week 48 Did Not Die	279 Participants	282 Participants
Number of Participants That Died by Week 48 Died	2 Participants	0 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With CAEs at Week 48 Discontinued with CAEs	9 Participants	17 Participants
Number of Participants That Discontinued With CAEs at Week 48 Did Not Discontinue with CAEs	272 Participants	265 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Serious CAEs at Week 48 Discontinued with Serious CAEs	7 Participants	4 Participants
Number of Participants That Discontinued With Serious CAEs at Week 48 Did Not Discontinue with Serious CAEs	274 Participants	278 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Drug-related CAEs at Week 48 Discontinued with Drug-related CAEs	3 Participants	11 Participants
Number of Participants That Discontinued With Drug-related CAEs at Week 48 Did not Discontinue with Drug-related CAEs	278 Participants	271 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 Discontiued with Serious Drug-related CAEs	1 Participants	2 Participants
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 Did Not Discontinue with Serious Drug-related CAEs	280 Participants	280 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 With LAEs	27 Participants	41 Participants
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 Without LAEs	254 Participants	241 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious LAEs at Week 48 With Serious LAEs	0 Participants	1 Participants
Number of Participants With Serious LAEs at Week 48 Without Serious LAEs	281 Participants	281 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Drug-related LAEs at Week 48 Without Drug-related LAEs	267 Participants	258 Participants
Number of Participants With Drug-related LAEs at Week 48 With Drug-related LAEs	14 Participants	24 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious Drug-related LAEs at Week 48 With Serious Drug-related LAEs	0 Participants	0 Participants
Number of Participants With Serious Drug-related LAEs at Week 48 Without Serious Drug-related LAEs	281 Participants	282 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Discontinued With LAEs at Week 48 Discontinued with LAEs	0 Participants	1 Participants
Number of Participants Discontinued With LAEs at Week 48 Did Not Discontinue with LAEs	281 Participants	281 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Discontinued With Drug-related LAEs at Week 48 Discontinued with Drug-related LAEs	0 Participants	1 Participants
Number of Participants Discontinued With Drug-related LAEs at Week 48 Did Not Discontinue with Drug-related LAEs	281 Participants	281 Participants

SECONDARY outcome

Timeframe: 48 Weeks

Population: All participants who took study medication and had HIV RNA tests performed were included in this analysis.

Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<400 copies/mL at Week 48.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=280 Participants 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. n=281 Participants 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.
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48	252 Participants	241 Participants

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: 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.

Mean change from baseline at Week 48 in CD4 cell count (cells/mm3)

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=258 Participants 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. n=251 Participants 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.
Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48	189.1 CD4 Cell Count (cells/mm3) Interval 173.9 to 204.3	163.3 CD4 Cell Count (cells/mm3) Interval 148.2 to 178.4

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 96.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96	228 Participants	222 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<400 copies/mL at Week 96.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96	240 Participants	229 Participants

SECONDARY outcome

Timeframe: Baseline and Week 96

Mean change from baseline at Week 96 in CD4 cell count (cells/mm3)

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=249 Participants 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. n=243 Participants 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.
Change From Baseline in CD4 Cell Count at Week 96	239.6 CD4 Cell Count (cells/mm3) Interval 219.8 to 259.4	224.8 CD4 Cell Count (cells/mm3) Interval 205.8 to 243.9

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 156.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156	212 Participants	192 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<400 copies/mL at Week 156.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156	224 Participants	203 Participants

SECONDARY outcome

Timeframe: Baseline and Week 156

Mean change from baseline at Week 156 in CD4 cell count (cells/mm3)

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=236 Participants 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. n=226 Participants 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.
Change From Baseline in CD4 Cell Count at Week 156	331.7 CD4 Cell Count (cells/mm3) Interval 309.3 to 354.2	295.2 CD4 Cell Count (cells/mm3) Interval 271.3 to 319.0

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 240.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=279 Participants 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. n=279 Participants 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.
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240	198 Participants	171 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.

Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<400 copies/mL at Week 240.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=279 Participants 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. n=279 Participants 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.
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240	206 Participants	181 Participants

SECONDARY outcome

Timeframe: Baseline and Week 240

Mean change from baseline at Week 240 in CD4 cell count (cells/mm3)

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=222 Participants 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. n=212 Participants 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.
Change From Baseline in CD4 Cell Count at Week 240	373.7 CD4 Cell Count (cells/mm3) Interval 344.6 to 402.8	311.6 CD4 Cell Count (cells/mm3) Interval 283.9 to 339.4

SECONDARY outcome

Timeframe: 8 Weeks

Population: All participants who took study medication were included in the analysis.

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

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 With Nervous System Symptoms	57 Participants	147 Participants
Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 Without Nervous System Symptoms	224 Participants	135 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With CAEs at Week 96 With CAEs	265 Participants	274 Participants
Number of Participants With CAEs at Week 96 Without CAEs	16 Participants	8 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With CAEs at Week 156 With CAEs	267 Participants	276 Participants
Number of Participants With CAEs at Week 156 Without CAEs	14 Participants	6 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With CAEs at Week 240 With CAEs	271 Participants	276 Participants
Number of Participants With CAEs at Week 240 Without CAEs	10 Participants	6 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious CAEs at Week 96 With Serious CAEs	37 Participants	33 Participants
Number of Participants With Serious CAEs at Week 96 Without Serious CAEs	244 Participants	249 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious CAEs at Week 156 With Serious CAEs	46 Participants	46 Participants
Number of Participants With Serious CAEs at Week 156 Without Serious CAEs	235 Participants	236 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious CAEs at Week 240 Without Serious CAEs	224 Participants	225 Participants
Number of Participants With Serious CAEs at Week 240 With Serious CAEs	57 Participants	57 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Drug-related CAEs at Week 96 With drug-related CAEs	132 Participants	220 Participants
Number of Participants With Drug-related CAEs at Week 96 Without drug-related CAEs	149 Participants	62 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Drug-related CAEs at Week 156 With drug-related CAEs	139 Participants	225 Participants
Number of Participants With Drug-related CAEs at Week 156 Without drug-related CAEs	142 Participants	57 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Drug-related CAEs at Week 240 With drug-related CAEs	146 Participants	226 Participants
Number of Participants With Drug-related CAEs at Week 240 Without drug-related CAEs	135 Participants	56 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious Drug-related CAEs at Week 96 With Serious Drug-related CAEs	6 Participants	5 Participants
Number of Participants With Serious Drug-related CAEs at Week 96 Without Serious Drug-related CAEs	275 Participants	277 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious Drug-related CAEs at Week 156 With Serious Drug-related CAEs	6 Participants	6 Participants
Number of Participants With Serious Drug-related CAEs at Week 156 Without Serious Drug-related CAEs	275 Participants	276 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious Drug-related CAEs at Week 240 With Serious Drug-related CAEs	8 Participants	7 Participants
Number of Participants With Serious Drug-related CAEs at Week 240 Without Serious Drug-related CAEs	273 Participants	275 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication were included in the analysis.

All participant deaths in the span of 96 weeks on study were recorded.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Died by Week 96 Died	3 Participants	0 Participants
Number of Participants That Died by Week 96 Did Not Die	278 Participants	282 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication were included in the analysis.

All participant deaths in the span of 156 weeks on study were recorded.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Died by Week 156 Died	4 Participants	1 Participants
Number of Participants That Died by Week 156 Did Not Die	277 Participants	281 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication were included in the analysis.

All participant deaths in the span of 240 weeks on study were recorded.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Died by Week 240 Died	5 Participants	5 Participants
Number of Participants That Died by Week 240 Did Not Die	276 Participants	277 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With CAEs at Week 96 Discontinued With CAEs	10 Participants	17 Participants
Number of Participants That Discontinued With CAEs at Week 96 Did Not Discontinue With CAEs	271 Participants	265 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With CAEs at Week 156 Discontinued With CAEs	13 Participants	21 Participants
Number of Participants That Discontinued With CAEs at Week 156 Did Not Discontinue With CAEs	268 Participants	261 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With CAEs at Week 240 Discontinued With CAEs	14 Participants	25 Participants
Number of Participants That Discontinued With CAEs at Week 240 Did Not Discontinue With CAEs	267 Participants	257 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Drug-related CAEs at Week 96 Discontinued With Drug-Related CAEs	3 Participants	12 Participants
Number of Participants That Discontinued With Drug-related CAEs at Week 96 Did Not Discontinue With Drug-Related CAEs	278 Participants	270 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Drug-related CAEs at Week 156 Discontinued With Drug-related CAEs	3 Participants	14 Participants
Number of Participants That Discontinued With Drug-related CAEs at Week 156 Did Not Discontinue With Drug-related CAEs	278 Participants	268 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Drug-related CAEs at Week 240 Discontinued With Drug-related CAEs	3 Participants	14 Participants
Number of Participants That Discontinued With Drug-related CAEs at Week 240 Did Not Discontinue With Drug-related CAEs	278 Participants	268 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Serious CAEs at Week 96 Discontinued With Serious CAEs	8 Participants	5 Participants
Number of Participants That Discontinued With Serious CAEs at Week 96 Did Not Discontinue With Serious CAEs	273 Participants	277 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Serious CAEs at Week 156 Discontinued With Serious CAEs	10 Participants	6 Participants
Number of Participants That Discontinued With Serious CAEs at Week 156 Did Not Discontinue With Serious CAEs	271 Participants	276 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Serious CAEs at Week 240 Discontinued With Serious CAEs	11 Participants	10 Participants
Number of Participants That Discontinued With Serious CAEs at Week 240 Did Not Discontinue With Serious CAEs	270 Participants	272 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 Discontinued With Serious Drug-related CAEs	1 Participants	2 Participants
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 Did Not Discontinue With Serious Drug-related CAEs	280 Participants	280 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 Discontinued With Serious Drug-related CAEs	1 Participants	2 Participants
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 Did Not Discontinue With Serious Drug-related CAEs	280 Participants	280 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 Discontinued With Serious Drug-related CAEs	1 Participants	2 Participants
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 Did Not Discontinue With Serious Drug-related CAEs	280 Participants	280 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With LAEs at Week 96 With LAEs	33 Participants	53 Participants
Number of Participants With LAEs at Week 96 Without LAEs	248 Participants	229 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With LAEs at Week 156 With LAEs	41 Participants	63 Participants
Number of Participants With LAEs at Week 156 Without LAEs	240 Participants	219 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With LAEs at Week 240 With LAEs	56 Participants	77 Participants
Number of Participants With LAEs at Week 240 Without LAEs	225 Participants	205 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Drug-related LAEs at Week 96 With Drug-related LAEs	18 Participants	29 Participants
Number of Participants With Drug-related LAEs at Week 96 Without Drug-related LAEs	263 Participants	253 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Drug-related LAEs at Week 156 With Drug-related LAEs	22 Participants	33 Participants
Number of Participants With Drug-related LAEs at Week 156 Without Drug-related LAEs	259 Participants	249 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Drug-related LAEs at Week 240 With Drug-related LAEs	26 Participants	43 Participants
Number of Participants With Drug-related LAEs at Week 240 Without Drug-related LAEs	255 Participants	239 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious LAEs at Week 96 With Serious LAEs	0 Participants	1 Participants
Number of Participants With Serious LAEs at Week 96 Without Serious LAEs	281 Participants	281 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious LAEs at Week 156 With Serious LAEs	0 Participants	2 Participants
Number of Participants With Serious LAEs at Week 156 Without Serious LAEs	281 Participants	280 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious LAEs at Week 240 With Serious LAEs	0 Participants	2 Participants
Number of Participants With Serious LAEs at Week 240 Without Serious LAEs	281 Participants	280 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious Drug-related LAEs at Week 96 With Serious Drug-related CAEs	0 Participants	0 Participants
Number of Participants With Serious Drug-related LAEs at Week 96 Without Serious Drug-related CAEs	281 Participants	282 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious Drug-related LAEs at Week 156 With Serious Drug-related CAEs	0 Participants	1 Participants
Number of Participants With Serious Drug-related LAEs at Week 156 Without Serious Drug-related CAEs	281 Participants	281 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants With Serious Drug-related LAEs at Week 240 With Serious Drug-related LAEs	0 Participants	1 Participants
Number of Participants With Serious Drug-related LAEs at Week 240 Without Serious Drug-related LAEs	281 Participants	281 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Discontinued With LAEs at Week 96 Discontinued With LAEs	0 Participants	2 Participants
Number of Participants Discontinued With LAEs at Week 96 Did Not Discontinue With LAEs	281 Participants	280 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Discontinued With LAEs at Week 156 Discontinued With LAEs	0 Participants	3 Participants
Number of Participants Discontinued With LAEs at Week 156 Did Not Discontinue With LAEs	281 Participants	279 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Discontinued With LAEs at Week 240 Discontinued With LAEs	0 Participants	3 Participants
Number of Participants Discontinued With LAEs at Week 240 Did Not Discontinue With LAEs	281 Participants	279 Participants

SECONDARY outcome

Timeframe: 96 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Discontinued With Drug-related LAEs at Week 96 Discontinued With Drug-related LAEs	0 Participants	1 Participants
Number of Participants Discontinued With Drug-related LAEs at Week 96 Did Not Discontinue With Drug-related LAEs	281 Participants	281 Participants

SECONDARY outcome

Timeframe: 156 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Discontinued With Drug-related LAEs at Week 156 Discontinued With Drug-related LAEs	0 Participants	2 Participants
Number of Participants Discontinued With Drug-related LAEs at Week 156 Did Not Discontinue With Drug-related LAEs	281 Participants	280 Participants

SECONDARY outcome

Timeframe: 240 Weeks

Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	MK-0518 400 mg b.i.d. n=281 Participants 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. n=282 Participants 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.
Number of Participants Discontinued With Drug-related LAEs at Week 240 Discontinued With Drug-related LAEs	0 Participants	2 Participants
Number of Participants Discontinued With Drug-related LAEs at Week 240 Did Not Discontinue With Drug-related LAEs	281 Participants	280 Participants

Adverse Events

MK-0518 400 mg b.i.d.

Serious events: 57 serious events

Other events: 257 other events

Deaths: 0 deaths

Efavirenz 600 mg q.h.s.

Serious events: 59 serious events

Other events: 263 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
Publication restrictions are in place

Restriction type: OTHER

Measure	MK-0518 400 mg b.i.d. n=281 participants at risk MK-0518 400 mg taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, taken PO (q.h.s.) on an empty stomach preferably at bedtime (q.h.s.). All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) daily with food 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. n=282 participants at risk Efavirenz 600 mg taken by mouth on an empty stomach preferably at bedtime (q.h.s.), and placebo to MK-0518 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.
Gastrointestinal disorders Abdominal pain	8.5% 24/281 • Number of events 30 • 240 weeks Adverse events are reported for the entire 240-week study.	6.7% 19/282 • Number of events 23 • 240 weeks Adverse events are reported for the entire 240-week study.
Gastrointestinal disorders Abdominal pain upper	2.8% 8/281 • Number of events 16 • 240 weeks Adverse events are reported for the entire 240-week study.	6.7% 19/282 • Number of events 20 • 240 weeks Adverse events are reported for the entire 240-week study.
Gastrointestinal disorders Diarrhoea	25.6% 72/281 • Number of events 104 • 240 weeks Adverse events are reported for the entire 240-week study.	27.0% 76/282 • Number of events 105 • 240 weeks Adverse events are reported for the entire 240-week study.
Gastrointestinal disorders Dyspepsia	8.9% 25/281 • Number of events 27 • 240 weeks Adverse events are reported for the entire 240-week study.	5.0% 14/282 • Number of events 18 • 240 weeks Adverse events are reported for the entire 240-week study.
Gastrointestinal disorders Flatulence	5.0% 14/281 • Number of events 17 • 240 weeks Adverse events are reported for the entire 240-week study.	6.7% 19/282 • Number of events 19 • 240 weeks Adverse events are reported for the entire 240-week study.
Gastrointestinal disorders Nausea	16.7% 47/281 • Number of events 68 • 240 weeks Adverse events are reported for the entire 240-week study.	14.5% 41/282 • Number of events 52 • 240 weeks Adverse events are reported for the entire 240-week study.
Gastrointestinal disorders Vomiting	8.2% 23/281 • Number of events 29 • 240 weeks Adverse events are reported for the entire 240-week study.	10.6% 30/282 • Number of events 38 • 240 weeks Adverse events are reported for the entire 240-week study.
General disorders Asthenia	6.0% 17/281 • Number of events 24 • 240 weeks Adverse events are reported for the entire 240-week study.	5.7% 16/282 • Number of events 16 • 240 weeks Adverse events are reported for the entire 240-week study.
General disorders Fatigue	9.3% 26/281 • Number of events 29 • 240 weeks Adverse events are reported for the entire 240-week study.	13.5% 38/282 • Number of events 46 • 240 weeks Adverse events are reported for the entire 240-week study.
General disorders Pyrexia	15.7% 44/281 • Number of events 62 • 240 weeks Adverse events are reported for the entire 240-week study.	13.8% 39/282 • Number of events 50 • 240 weeks Adverse events are reported for the entire 240-week study.
Infections and infestations Bronchitis	10.3% 29/281 • Number of events 48 • 240 weeks Adverse events are reported for the entire 240-week study.	10.6% 30/282 • Number of events 48 • 240 weeks Adverse events are reported for the entire 240-week study.
Infections and infestations Gastroenteritis	6.0% 17/281 • Number of events 19 • 240 weeks Adverse events are reported for the entire 240-week study.	6.7% 19/282 • Number of events 20 • 240 weeks Adverse events are reported for the entire 240-week study.
Infections and infestations Genital herpes	4.3% 12/281 • Number of events 17 • 240 weeks Adverse events are reported for the entire 240-week study.	5.3% 15/282 • Number of events 19 • 240 weeks Adverse events are reported for the entire 240-week study.
Infections and infestations Herpes zoster	5.0% 14/281 • Number of events 17 • 240 weeks Adverse events are reported for the entire 240-week study.	5.7% 16/282 • Number of events 19 • 240 weeks Adverse events are reported for the entire 240-week study.
Infections and infestations Influenza	11.7% 33/281 • Number of events 58 • 240 weeks Adverse events are reported for the entire 240-week study.	13.5% 38/282 • Number of events 68 • 240 weeks Adverse events are reported for the entire 240-week study.
Infections and infestations Nasopharyngitis	26.7% 75/281 • Number of events 121 • 240 weeks Adverse events are reported for the entire 240-week study.	22.3% 63/282 • Number of events 123 • 240 weeks Adverse events are reported for the entire 240-week study.
Infections and infestations Pharyngitis	9.6% 27/281 • Number of events 33 • 240 weeks Adverse events are reported for the entire 240-week study.	9.2% 26/282 • Number of events 33 • 240 weeks Adverse events are reported for the entire 240-week study.
Infections and infestations Sinusitis	8.2% 23/281 • Number of events 31 • 240 weeks Adverse events are reported for the entire 240-week study.	8.2% 23/282 • Number of events 31 • 240 weeks Adverse events are reported for the entire 240-week study.
Infections and infestations Upper respiratory tract infection	21.4% 60/281 • Number of events 95 • 240 weeks Adverse events are reported for the entire 240-week study.	20.2% 57/282 • Number of events 85 • 240 weeks Adverse events are reported for the entire 240-week study.
Investigations Alanine aminotransferase increased	6.8% 19/281 • Number of events 33 • 240 weeks Adverse events are reported for the entire 240-week study.	9.9% 28/282 • Number of events 49 • 240 weeks Adverse events are reported for the entire 240-week study.
Investigations Aspartate aminotransferase increased	7.5% 21/281 • Number of events 37 • 240 weeks Adverse events are reported for the entire 240-week study.	8.9% 25/282 • Number of events 44 • 240 weeks Adverse events are reported for the entire 240-week study.
Metabolism and nutrition disorders Decreased appetite	4.3% 12/281 • Number of events 18 • 240 weeks Adverse events are reported for the entire 240-week study.	6.7% 19/282 • Number of events 20 • 240 weeks Adverse events are reported for the entire 240-week study.
Musculoskeletal and connective tissue disorders Arthralgia	8.5% 24/281 • Number of events 29 • 240 weeks Adverse events are reported for the entire 240-week study.	11.7% 33/282 • Number of events 34 • 240 weeks Adverse events are reported for the entire 240-week study.
Musculoskeletal and connective tissue disorders Back pain	12.1% 34/281 • Number of events 43 • 240 weeks Adverse events are reported for the entire 240-week study.	9.9% 28/282 • Number of events 34 • 240 weeks Adverse events are reported for the entire 240-week study.
Musculoskeletal and connective tissue disorders Myalgia	3.9% 11/281 • Number of events 12 • 240 weeks Adverse events are reported for the entire 240-week study.	5.3% 15/282 • Number of events 19 • 240 weeks Adverse events are reported for the entire 240-week study.
Musculoskeletal and connective tissue disorders Pain in extremity	6.4% 18/281 • Number of events 23 • 240 weeks Adverse events are reported for the entire 240-week study.	5.3% 15/282 • Number of events 17 • 240 weeks Adverse events are reported for the entire 240-week study.
Nervous system disorders Dizziness	16.4% 46/281 • Number of events 49 • 240 weeks Adverse events are reported for the entire 240-week study.	38.3% 108/282 • Number of events 140 • 240 weeks Adverse events are reported for the entire 240-week study.
Nervous system disorders Headache	26.0% 73/281 • Number of events 127 • 240 weeks Adverse events are reported for the entire 240-week study.	28.4% 80/282 • Number of events 109 • 240 weeks Adverse events are reported for the entire 240-week study.
Nervous system disorders Somnolence	1.1% 3/281 • Number of events 5 • 240 weeks Adverse events are reported for the entire 240-week study.	7.8% 22/282 • Number of events 27 • 240 weeks Adverse events are reported for the entire 240-week study.
Psychiatric disorders Abnormal dreams	8.2% 23/281 • Number of events 29 • 240 weeks Adverse events are reported for the entire 240-week study.	13.1% 37/282 • Number of events 43 • 240 weeks Adverse events are reported for the entire 240-week study.
Psychiatric disorders Anxiety	8.9% 25/281 • Number of events 25 • 240 weeks Adverse events are reported for the entire 240-week study.	11.0% 31/282 • Number of events 31 • 240 weeks Adverse events are reported for the entire 240-week study.
Psychiatric disorders Depression	9.6% 27/281 • Number of events 32 • 240 weeks Adverse events are reported for the entire 240-week study.	11.7% 33/282 • Number of events 38 • 240 weeks Adverse events are reported for the entire 240-week study.
Psychiatric disorders Insomnia	15.7% 44/281 • Number of events 56 • 240 weeks Adverse events are reported for the entire 240-week study.	14.9% 42/282 • Number of events 49 • 240 weeks Adverse events are reported for the entire 240-week study.
Psychiatric disorders Nightmare	3.6% 10/281 • Number of events 12 • 240 weeks Adverse events are reported for the entire 240-week study.	5.3% 15/282 • Number of events 19 • 240 weeks Adverse events are reported for the entire 240-week study.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 47/281 • Number of events 64 • 240 weeks Adverse events are reported for the entire 240-week study.	12.1% 34/282 • Number of events 47 • 240 weeks Adverse events are reported for the entire 240-week study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.8% 22/281 • Number of events 22 • 240 weeks Adverse events are reported for the entire 240-week study.	5.3% 15/282 • Number of events 15 • 240 weeks Adverse events are reported for the entire 240-week study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	6.4% 18/281 • Number of events 20 • 240 weeks Adverse events are reported for the entire 240-week study.	2.1% 6/282 • Number of events 8 • 240 weeks Adverse events are reported for the entire 240-week study.
Skin and subcutaneous tissue disorders Pruritus	4.3% 12/281 • Number of events 12 • 240 weeks Adverse events are reported for the entire 240-week study.	5.3% 15/282 • Number of events 15 • 240 weeks Adverse events are reported for the entire 240-week study.
Skin and subcutaneous tissue disorders Rash	7.8% 22/281 • Number of events 26 • 240 weeks Adverse events are reported for the entire 240-week study.	13.8% 39/282 • Number of events 46 • 240 weeks Adverse events are reported for the entire 240-week study.
Vascular disorders Hypertension	6.4% 18/281 • Number of events 20 • 240 weeks Adverse events are reported for the entire 240-week study.	6.4% 18/282 • Number of events 20 • 240 weeks Adverse events are reported for the entire 240-week study.