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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
566
400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks
600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks
One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)
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.
Time frame: 48 Weeks
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Time frame: 48 Weeks
Number of Participants With Serious CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 48 Weeks
Number of Participants With Drug-related CAEs at Week 48
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 48 Weeks
Number of Participants With Serious Drug-related CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
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Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks
Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks
Time frame: 48 Weeks
Number of Participants That Died by Week 48
All participant deaths in the span of 48 weeks on study were recorded.
Time frame: 48 Weeks
Number of Participants That Discontinued With CAEs at Week 48
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Time frame: 48 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 48 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 48
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 48 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 48 Weeks
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Time frame: 48 Weeks
Number of Participants With Serious LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 48 Weeks
Number of Participants With Drug-related LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 48 Weeks
Number of Participants With Serious Drug-related LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 48 Weeks
Number of Participants Discontinued With LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Time frame: 48 Weeks
Number of Participants Discontinued With Drug-related LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse events (AEs) in this study were defined as "drug-related" if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone.
Time frame: 48 Weeks
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.
Time frame: 48 Weeks
Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48
Mean change from baseline at Week 48 in CD4 cell count (cells/mm3)
Time frame: Baseline and Week 48
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96
Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 96.
Time frame: 96 Weeks
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96
Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<400 copies/mL at Week 96.
Time frame: 96 Weeks
Change From Baseline in CD4 Cell Count at Week 96
Mean change from baseline at Week 96 in CD4 cell count (cells/mm3)
Time frame: Baseline and Week 96
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156
Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 156.
Time frame: 156 Weeks
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156
Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<400 copies/mL at Week 156.
Time frame: 156 Weeks
Change From Baseline in CD4 Cell Count at Week 156
Mean change from baseline at Week 156 in CD4 cell count (cells/mm3)
Time frame: Baseline and Week 156
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240
Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 240.
Time frame: 240 Weeks
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240
Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<400 copies/mL at Week 240.
Time frame: 240 Weeks
Change From Baseline in CD4 Cell Count at Week 240
Mean change from baseline at Week 240 in CD4 cell count (cells/mm3)
Time frame: Baseline and Week 240
Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8
Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression
Time frame: 8 Weeks
Number of Participants With CAEs at Week 96
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Time frame: 96 Weeks
Number of Participants With CAEs at Week 156
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Time frame: 156 Weeks
Number of Participants With CAEs at Week 240
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Time frame: 240 Weeks
Number of Participants With Serious CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 96 Weeks
Number of Participants With Serious CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 156 Weeks
Number of Participants With Serious CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 240 Weeks
Number of Participants With Drug-related CAEs at Week 96
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 96 Weeks
Number of Participants With Drug-related CAEs at Week 156
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 156 Weeks
Number of Participants With Drug-related CAEs at Week 240
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 240 Weeks
Number of Participants With Serious Drug-related CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 96 Weeks
Number of Participants With Serious Drug-related CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 156 Weeks
Number of Participants With Serious Drug-related CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 240 Weeks
Number of Participants That Died by Week 96
All participant deaths in the span of 96 weeks on study were recorded.
Time frame: 96 Weeks
Number of Participants That Died by Week 156
All participant deaths in the span of 156 weeks on study were recorded.
Time frame: 156 Weeks
Number of Participants That Died by Week 240
All participant deaths in the span of 240 weeks on study were recorded.
Time frame: 240 Weeks
Number of Participants That Discontinued With CAEs at Week 96
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Time frame: 96 Weeks
Number of Participants That Discontinued With CAEs at Week 156
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Time frame: 156 Weeks
Number of Participants That Discontinued With CAEs at Week 240
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Time frame: 240 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 96
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 96 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 156
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 156 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 240
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 240 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 96 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 156 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 240 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 96 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 156 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 240 Weeks
Number of Participants With LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Time frame: 96 Weeks
Number of Participants With LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Time frame: 156 Weeks
Number of Participants With LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Time frame: 240 Weeks
Number of Participants With Drug-related LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 96 Weeks
Number of Participants With Drug-related LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 156 Weeks
Number of Participants With Drug-related LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 240 Weeks
Number of Participants With Serious LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 96 Weeks
Number of Participants With Serious LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 156 Weeks
Number of Participants With Serious LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: 240 Weeks
Number of Participants With Serious Drug-related LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 96 Weeks
Number of Participants With Serious Drug-related LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 156 Weeks
Number of Participants With Serious Drug-related LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 240 Weeks
Number of Participants Discontinued With LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Time frame: 96 Weeks
Number of Participants Discontinued With LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Time frame: 156 Weeks
Number of Participants Discontinued With LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Time frame: 240 Weeks
Number of Participants Discontinued With Drug-related LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 96 Weeks
Number of Participants Discontinued With Drug-related LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 156 Weeks
Number of Participants Discontinued With Drug-related LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Time frame: 240 Weeks