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)

HIV Infections Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369941
• Other study ID #: 0518-021
• Secondary ID: MK-0518-0212006_
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2006
• Last updated: September 1, 2015
• Start date: August 2006
• Est. completion date: February 2012

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: February 2012
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is a male or female at least 18 years of age

• Participant is HIV positive

• Participant is naïve to antiretroviral therapy (ART) and has not received any ART

Exclusion Criteria:

• Participant has received approved or experimental antiretroviral agents in the past

• Participant has been treated for a viral infection other than HIV such as hepatitis B virus infection with an agent that is active against HIV including but not limited to adefovir or lamivudine (= 7 days total)

• Participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz

• Participant has used another experimental HIV-integrase inhibitor

• Participant has a current (active) diagnosis of acute hepatitis due to any cause

• Participants with chronic hepatitis including chronic hepatitis B and/or C may enter the study as long as they have stable liver function tests

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• MK-0518
400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks
• Comparator: efavirenz
600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks
• Comparator: Truvada
One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)
• Comparator: Placebo to MK-0518
Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks
• Comparator: Placebo to efavirenz
Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (8)

DeJesus E, Rockstroh JK, Lennox JL, Saag MS, Lazzarin A, Zhao J, Wan H, Rodgers AJ, Walker ML, Miller M, DiNubile MJ, Nguyen BY, Teppler H, Leavitt R, Sklar P; STARTMRK Investigators. Efficacy of raltegravir versus efavirenz when combined with tenofovir/e — View Citation

Lennox JL, Dejesus E, Berger DS, Lazzarin A, Pollard RB, Ramalho Madruga JV, Zhao J, Wan H, Gilbert CL, Teppler H, Rodgers AJ, Barnard RJ, Miller MD, Dinubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK Investigators. Raltegravir versus Efavirenz regimens — View Citation

Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, Zhao J, Xu X, Williams-Diaz A, Rodgers AJ, Barnard RJ, Miller MD, DiNubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK investigators. Safety and efficacy of raltegravir-based versus efav — View Citation

Nguyen BY, Isaacs RD, Teppler H, Leavitt RY, Sklar P, Iwamoto M, Wenning LA, Miller MD, Chen J, Kemp R, Xu W, Fromtling RA, Vacca JP, Young SD, Rowley M, Lower MW, Gottesdiener KM, Hazuda DJ. Raltegravir: the first HIV-1 integrase strand transfer inhibito — View Citation

Rockstroh J, Teppler H, Zhao J, Sklar P, Harvey C, Strohmaier K, Leavitt R, Nguyen BY. Safety and efficacy of raltegravir in patients with HIV-1 and hepatitis B and/or C virus coinfection. HIV Med. 2012 Feb;13(2):127-31. doi: 10.1111/j.1468-1293.2011.0093 — View Citation

Rockstroh JK, Lennox JL, Dejesus E, Saag MS, Lazzarin A, Wan H, Walker ML, Xu X, Zhao J, Teppler H, Dinubile MJ, Rodgers AJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK Investigators. Long-term treatment with raltegravir or efavirenz combined with tenofovir/e — View Citation

Rockstroh JK, Teppler H, Zhao J, Sklar P, Miller MD, Harvey CM, Strohmaier KM, Leavitt RY, Nguyen BY. Clinical efficacy of raltegravir against B and non-B subtype HIV-1 in phase III clinical studies. AIDS. 2011 Jul 17;25(11):1365-9. doi: 10.1097/QAD.0b013 — View Citation

Teppler H, Brown DD, Leavitt RY, Sklar P, Wan H, Xu X, Lievano F, Lehman HP, Mast TC, Nguyen BY. Long-term safety from the raltegravir clinical development program. Curr HIV Res. 2011 Jan;9(1):40-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48	Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48.	48 Weeks	No
Primary	Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.	48 Weeks	Yes
Primary	Number of Participants With Serious CAEs at Week 48	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	48 Weeks	Yes
Primary	Number of Participants With Drug-related CAEs at Week 48	Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	48 Weeks	Yes
Primary	Number of Participants With Serious Drug-related CAEs at Week 48	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	48 Weeks	Yes
Primary	Number of Participants That Died by Week 48	All participant deaths in the span of 48 weeks on study were recorded.	48 Weeks	Yes
Primary	Number of Participants That Discontinued With CAEs at Week 48	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.	48 Weeks	Yes
Primary	Number of Participants That Discontinued With Serious CAEs at Week 48	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	48 Weeks	Yes
Primary	Number of Participants That Discontinued With Drug-related CAEs at Week 48	Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	48 Weeks	Yes
Primary	Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	48 Weeks	Yes
Primary	Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.	48 Weeks	Yes
Primary	Number of Participants With Serious LAEs at Week 48	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	48 Weeks	Yes
Primary	Number of Participants With Drug-related LAEs at Week 48	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	48 Weeks	Yes
Primary	Number of Participants With Serious Drug-related LAEs at Week 48	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	48 Weeks	Yes
Primary	Number of Participants Discontinued With LAEs at Week 48	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.	48 Weeks	Yes
Primary	Number of Participants Discontinued With Drug-related LAEs at Week 48	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Adverse events (AEs) in this study were defined as "drug-related" if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone.	48 Weeks	Yes
Secondary	Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48	Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48.	48 Weeks	No
Secondary	Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48	Mean change from baseline at Week 48 in CD4 cell count (cells/mm3)	Baseline and Week 48	No
Secondary	Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96	Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96.	96 Weeks	No
Secondary	Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96	Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96.	96 Weeks	No
Secondary	Change From Baseline in CD4 Cell Count at Week 96	Mean change from baseline at Week 96 in CD4 cell count (cells/mm3)	Baseline and Week 96	No
Secondary	Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156	Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156.	156 Weeks	No
Secondary	Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156	Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156.	156 Weeks	No
Secondary	Change From Baseline in CD4 Cell Count at Week 156	Mean change from baseline at Week 156 in CD4 cell count (cells/mm3)	Baseline and Week 156	No
Secondary	Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240	Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240.	240 Weeks	No
Secondary	Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240	Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240.	240 Weeks	No
Secondary	Change From Baseline in CD4 Cell Count at Week 240	Mean change from baseline at Week 240 in CD4 cell count (cells/mm3)	Baseline and Week 240	No
Secondary	Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8	Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression	8 Weeks	Yes
Secondary	Number of Participants With CAEs at Week 96	An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.	96 Weeks	Yes
Secondary	Number of Participants With CAEs at Week 156	An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.	156 Weeks	Yes
Secondary	Number of Participants With CAEs at Week 240	An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.	240 Weeks	Yes
Secondary	Number of Participants With Serious CAEs at Week 96	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	96 Weeks	Yes
Secondary	Number of Participants With Serious CAEs at Week 156	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	156 Weeks	Yes
Secondary	Number of Participants With Serious CAEs at Week 240	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	240 Weeks	Yes
Secondary	Number of Participants With Drug-related CAEs at Week 96	Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	96 Weeks	Yes
Secondary	Number of Participants With Drug-related CAEs at Week 156	Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	156 Weeks	Yes
Secondary	Number of Participants With Drug-related CAEs at Week 240	Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	240 Weeks	Yes
Secondary	Number of Participants With Serious Drug-related CAEs at Week 96	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	96 Weeks	Yes
Secondary	Number of Participants With Serious Drug-related CAEs at Week 156	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	156 Weeks	Yes
Secondary	Number of Participants With Serious Drug-related CAEs at Week 240	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	240 Weeks	Yes
Secondary	Number of Participants That Died by Week 96	All participant deaths in the span of 96 weeks on study were recorded.	96 Weeks	Yes
Secondary	Number of Participants That Died by Week 156	All participant deaths in the span of 156 weeks on study were recorded.	156 Weeks	Yes
Secondary	Number of Participants That Died by Week 240	All participant deaths in the span of 240 weeks on study were recorded.	240 Weeks	Yes
Secondary	Number of Participants That Discontinued With CAEs at Week 96	An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.	96 Weeks	Yes
Secondary	Number of Participants That Discontinued With CAEs at Week 156	An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.	156 Weeks	Yes
Secondary	Number of Participants That Discontinued With CAEs at Week 240	An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.	240 Weeks	Yes
Secondary	Number of Participants That Discontinued With Drug-related CAEs at Week 96	Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	96 Weeks	Yes
Secondary	Number of Participants That Discontinued With Drug-related CAEs at Week 156	Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	156 Weeks	Yes
Secondary	Number of Participants That Discontinued With Drug-related CAEs at Week 240	Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	240 Weeks	Yes
Secondary	Number of Participants That Discontinued With Serious CAEs at Week 96	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	96 Weeks	Yes
Secondary	Number of Participants That Discontinued With Serious CAEs at Week 156	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	156 Weeks	Yes
Secondary	Number of Participants That Discontinued With Serious CAEs at Week 240	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	240 Weeks	Yes
Secondary	Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	96 Weeks	Yes
Secondary	Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	156 Weeks	Yes
Secondary	Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240	Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	240 Weeks	Yes
Secondary	Number of Participants With LAEs at Week 96	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.	96 Weeks	Yes
Secondary	Number of Participants With LAEs at Week 156	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.	156 Weeks	Yes
Secondary	Number of Participants With LAEs at Week 240	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.	240 Weeks	Yes
Secondary	Number of Participants With Drug-related LAEs at Week 96	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	96 Weeks	Yes
Secondary	Number of Participants With Drug-related LAEs at Week 156	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	156 Weeks	Yes
Secondary	Number of Participants With Drug-related LAEs at Week 240	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	240 Weeks	Yes
Secondary	Number of Participants With Serious LAEs at Week 96	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	96 Weeks	Yes
Secondary	Number of Participants With Serious LAEs at Week 156	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	156 Weeks	Yes
Secondary	Number of Participants With Serious LAEs at Week 240	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.	240 Weeks	Yes
Secondary	Number of Participants With Serious Drug-related LAEs at Week 96	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	96 Weeks	Yes
Secondary	Number of Participants With Serious Drug-related LAEs at Week 156	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	156 Weeks	Yes
Secondary	Number of Participants With Serious Drug-related LAEs at Week 240	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	240 Weeks	Yes
Secondary	Number of Participants Discontinued With LAEs at Week 96	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.	96 Weeks	Yes
Secondary	Number of Participants Discontinued With LAEs at Week 156	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.	156 Weeks	Yes
Secondary	Number of Participants Discontinued With LAEs at Week 240	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.	240 Weeks	Yes
Secondary	Number of Participants Discontinued With Drug-related LAEs at Week 96	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	96 Weeks	Yes
Secondary	Number of Participants Discontinued With Drug-related LAEs at Week 156	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	156 Weeks	Yes
Secondary	Number of Participants Discontinued With Drug-related LAEs at Week 240	A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.; Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.	240 Weeks	Yes