HIV Infections
Conditions
Brief 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.
Interventions
DRUGMK-0518
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
DRUGComparator: Truvada
One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)
DRUGComparator: Placebo to MK-0518
Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks
DRUGComparator: Placebo to efavirenz
Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 | 48 Weeks | Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 48. |
| Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 | 48 Weeks | 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. |
| Number of Participants With Serious CAEs at Week 48 | 48 Weeks | 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. |
| Number of Participants With Drug-related CAEs at Week 48 | 48 Weeks | 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. |
| Number of Participants With Serious Drug-related CAEs at Week 48 | 48 Weeks | 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. |
| Number of Participants That Died by Week 48 | 48 Weeks | All participant deaths in the span of 48 weeks on study were recorded. |
| Number of Participants That Discontinued With CAEs at Week 48 | 48 Weeks | 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. |
| Number of Participants That Discontinued With Serious CAEs at Week 48 | 48 Weeks | 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. |
| Number of Participants That Discontinued With Drug-related CAEs at Week 48 | 48 Weeks | 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. |
| Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 | 48 Weeks | 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. |
| Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 | 48 Weeks | 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. |
| Number of Participants With Serious LAEs at Week 48 | 48 Weeks | 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. |
| Number of Participants With Drug-related LAEs at Week 48 | 48 Weeks | 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. |
| Number of Participants With Serious Drug-related LAEs at Week 48 | 48 Weeks | 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. |
| Number of Participants Discontinued With LAEs at Week 48 | 48 Weeks | 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. |
| Number of Participants Discontinued With Drug-related LAEs at Week 48 | 48 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious CAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants With Serious CAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants With Drug-related CAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants With Drug-related CAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants With Drug-related CAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants With Serious Drug-related CAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants With Serious Drug-related CAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants With Serious Drug-related CAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants That Died by Week 96 | 96 Weeks | All participant deaths in the span of 96 weeks on study were recorded. |
| Number of Participants That Died by Week 156 | 156 Weeks | All participant deaths in the span of 156 weeks on study were recorded. |
| Number of Participants That Died by Week 240 | 240 Weeks | All participant deaths in the span of 240 weeks on study were recorded. |
| Number of Participants That Discontinued With CAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants That Discontinued With CAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants That Discontinued With CAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants That Discontinued With Drug-related CAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants That Discontinued With Drug-related CAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants That Discontinued With Drug-related CAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants That Discontinued With Serious CAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants That Discontinued With Serious CAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants That Discontinued With Serious CAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants With LAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants With LAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants With LAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants With Drug-related LAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants With Drug-related LAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants With Drug-related LAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 | 48 Weeks | Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<400 copies/mL at Week 48. |
| Number of Participants With Serious LAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants With Serious LAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants With Serious Drug-related LAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants With Serious Drug-related LAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants With Serious Drug-related LAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants Discontinued With LAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants Discontinued With LAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants Discontinued With LAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants Discontinued With Drug-related LAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants Discontinued With Drug-related LAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants Discontinued With Drug-related LAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants With Serious LAEs at Week 96 | 96 Weeks | 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. |
| Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48 | Baseline and Week 48 | Mean change from baseline at Week 48 in CD4 cell count (cells/mm3) |
| Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96 | 96 Weeks | Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 96. |
| Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96 | 96 Weeks | Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<400 copies/mL at Week 96. |
| Change From Baseline in CD4 Cell Count at Week 96 | Baseline and Week 96 | Mean change from baseline at Week 96 in CD4 cell count (cells/mm3) |
| Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156 | 156 Weeks | Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 156. |
| Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156 | 156 Weeks | Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<400 copies/mL at Week 156. |
| Change From Baseline in CD4 Cell Count at Week 156 | Baseline and Week 156 | Mean change from baseline at Week 156 in CD4 cell count (cells/mm3) |
| Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240 | 240 Weeks | Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<50 copies/mL at Week 240. |
| Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240 | 240 Weeks | Antiretroviral activity was evaluated for participants who achieved HIV RNA level \<400 copies/mL at Week 240. |
| Change From Baseline in CD4 Cell Count at Week 240 | Baseline and Week 240 | Mean change from baseline at Week 240 in CD4 cell count (cells/mm3) |
| Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 | 8 Weeks | 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 |
| Number of Participants With CAEs at Week 96 | 96 Weeks | 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. |
| Number of Participants With CAEs at Week 156 | 156 Weeks | 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. |
| Number of Participants With CAEs at Week 240 | 240 Weeks | 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. |
| Number of Participants With Serious CAEs at Week 96 | 96 Weeks | 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. |
Participant flow
Recruitment details
Primary therapy period: 14-Sep-2006 to 06-May-2009 Multicenter (67) in the United States (18) and Ex-US (49)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 281 |
| 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. | 282 |
| Total | 563 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 14 | 28 |
| Overall Study | Completed, Did Not Enter Extension | 5 | 6 |
| Overall Study | Employment Interfered with Study Visits | 1 | 0 |
| Overall Study | Lack of Efficacy | 6 | 10 |
| Overall Study | Lost to Follow-up | 12 | 22 |
| Overall Study | Miscellaneous | 3 | 3 |
| Overall Study | Moved | 11 | 5 |
| Overall Study | Never Treated | 1 | 2 |
| Overall Study | Pregnancy | 4 | 2 |
| Overall Study | Protocol Violation | 5 | 3 |
| Overall Study | Study Site Terminated | 2 | 0 |
| Overall Study | Treatment with Prohibited Medication | 3 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 18 |
Baseline characteristics
| Characteristic | Efavirenz 600 mg q.h.s. | Total | MK-0518 400 mg b.i.d. |
|---|---|---|---|
| Age, Continuous | 37 years | 37 years | 38 years |
| Cluster of Differentiation 4 (CD4) Cell Count | 217 Cells/mm^3 | 218 Cells/mm^3 | 219 Cells/mm^3 |
| Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) | 106215 Copies/mL | 104702 Copies/mL | 103205 Copies/mL |
| Race/Ethnicity, Customized Asian | 32 participants | 68 participants | 36 participants |
| Race/Ethnicity, Customized Black | 23 participants | 56 participants | 33 participants |
| Race/Ethnicity, Customized Hispanic | 67 participants | 127 participants | 60 participants |
| Race/Ethnicity, Customized Others | 37 participants | 73 participants | 36 participants |
| Race/Ethnicity, Customized White | 123 participants | 239 participants | 116 participants |
| Sex: Female, Male Female | 51 Participants | 105 Participants | 54 Participants |
| Sex: Female, Male Male | 231 Participants | 458 Participants | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 257 / 281 | 263 / 282 |
| serious Total, serious adverse events | 57 / 281 | 59 / 282 |
Outcome results
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.
Time frame: 48 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With Drug-related LAEs at Week 48 | Discontinued with Drug-related LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With Drug-related LAEs at Week 48 | Did Not Discontinue with Drug-related LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With Drug-related LAEs at Week 48 | Discontinued with Drug-related LAEs | 1 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With Drug-related LAEs at Week 48 | Did Not Discontinue with Drug-related LAEs | 281 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With LAEs at Week 48 | Discontinued with LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With LAEs at Week 48 | Did Not Discontinue with LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With LAEs at Week 48 | Discontinued with LAEs | 1 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With LAEs at Week 48 | Did Not Discontinue with LAEs | 281 Participants |
Primary
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
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Died by Week 48 | Died | 2 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Died by Week 48 | Did Not Die | 279 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Died by Week 48 | Died | 0 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Died by Week 48 | Did Not Die | 282 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With CAEs at Week 48 | Discontinued with CAEs | 9 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With CAEs at Week 48 | Did Not Discontinue with CAEs | 272 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With CAEs at Week 48 | Did Not Discontinue with CAEs | 265 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With CAEs at Week 48 | Discontinued with CAEs | 17 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Drug-related CAEs at Week 48 | Discontinued with Drug-related CAEs | 3 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Drug-related CAEs at Week 48 | Did not Discontinue with Drug-related CAEs | 278 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Drug-related CAEs at Week 48 | Discontinued with Drug-related CAEs | 11 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Drug-related CAEs at Week 48 | Did not Discontinue with Drug-related CAEs | 271 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious CAEs at Week 48 | Discontinued with Serious CAEs | 7 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious CAEs at Week 48 | Did Not Discontinue with Serious CAEs | 274 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious CAEs at Week 48 | Discontinued with Serious CAEs | 4 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious CAEs at Week 48 | Did Not Discontinue with Serious CAEs | 278 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 | Discontiued with Serious Drug-related CAEs | 1 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 | Did Not Discontinue with Serious Drug-related CAEs | 280 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 | Discontiued with Serious Drug-related CAEs | 2 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 | Did Not Discontinue with Serious Drug-related CAEs | 280 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 | 241 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 | 230 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 | With CAEs | 253 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 | Without CAEs | 28 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 | With CAEs | 272 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 | Without CAEs | 10 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related CAEs at Week 48 | With Drug-related CAEs | 124 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related CAEs at Week 48 | Without Drug-related CAEs | 157 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related CAEs at Week 48 | With Drug-related CAEs | 217 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related CAEs at Week 48 | Without Drug-related CAEs | 65 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related LAEs at Week 48 | With Drug-related LAEs | 14 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related LAEs at Week 48 | Without Drug-related LAEs | 267 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related LAEs at Week 48 | With Drug-related LAEs | 24 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related LAEs at Week 48 | Without Drug-related LAEs | 258 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 | Without LAEs | 254 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 | With LAEs | 27 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 | With LAEs | 41 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 | Without LAEs | 241 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious CAEs at Week 48 | With Serious CAEs | 28 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious CAEs at Week 48 | Without Serious CAEs | 253 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious CAEs at Week 48 | With Serious CAEs | 27 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious CAEs at Week 48 | Without Serious CAEs | 255 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related CAEs at Week 48 | With Serious Drug-related CAEs | 4 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related CAEs at Week 48 | Without Serious Drug-related CAEs | 277 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related CAEs at Week 48 | With Serious Drug-related CAEs | 5 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related CAEs at Week 48 | Without Serious Drug-related CAEs | 277 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related LAEs at Week 48 | With Serious Drug-related LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related LAEs at Week 48 | Without Serious Drug-related LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related LAEs at Week 48 | With Serious Drug-related LAEs | 0 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related LAEs at Week 48 | Without Serious Drug-related LAEs | 282 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious LAEs at Week 48 | With Serious LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious LAEs at Week 48 | Without Serious LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious LAEs at Week 48 | With Serious LAEs | 1 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious LAEs at Week 48 | Without Serious LAEs | 281 Participants |
Secondary
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
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Change From Baseline in CD4 Cell Count at Week 156 | 331.7 CD4 Cell Count (cells/mm3) |
| Efavirenz 600 mg q.h.s. | Change From Baseline in CD4 Cell Count at Week 156 | 295.2 CD4 Cell Count (cells/mm3) |
Secondary
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
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Change From Baseline in CD4 Cell Count at Week 240 | 373.7 CD4 Cell Count (cells/mm3) |
| Efavirenz 600 mg q.h.s. | Change From Baseline in CD4 Cell Count at Week 240 | 311.6 CD4 Cell Count (cells/mm3) |
Secondary
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
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Change From Baseline in CD4 Cell Count at Week 96 | 239.6 CD4 Cell Count (cells/mm3) |
| Efavirenz 600 mg q.h.s. | Change From Baseline in CD4 Cell Count at Week 96 | 224.8 CD4 Cell Count (cells/mm3) |
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48 | 189.1 CD4 Cell Count (cells/mm3) |
| Efavirenz 600 mg q.h.s. | Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48 | 163.3 CD4 Cell Count (cells/mm3) |
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.
Time frame: 156 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With Drug-related LAEs at Week 156 | Discontinued With Drug-related LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With Drug-related LAEs at Week 156 | Did Not Discontinue With Drug-related LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With Drug-related LAEs at Week 156 | Discontinued With Drug-related LAEs | 2 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With Drug-related LAEs at Week 156 | Did Not Discontinue With Drug-related LAEs | 280 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With Drug-related LAEs at Week 240 | Discontinued With Drug-related LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With Drug-related LAEs at Week 240 | Did Not Discontinue With Drug-related LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With Drug-related LAEs at Week 240 | Discontinued With Drug-related LAEs | 2 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With Drug-related LAEs at Week 240 | Did Not Discontinue With Drug-related LAEs | 280 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With Drug-related LAEs at Week 96 | Discontinued With Drug-related LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With Drug-related LAEs at Week 96 | Did Not Discontinue With Drug-related LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With Drug-related LAEs at Week 96 | Discontinued With Drug-related LAEs | 1 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With Drug-related LAEs at Week 96 | Did Not Discontinue With Drug-related LAEs | 281 Participants |
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.
Time frame: 156 Weeks
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With LAEs at Week 156 | Discontinued With LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With LAEs at Week 156 | Did Not Discontinue With LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With LAEs at Week 156 | Discontinued With LAEs | 3 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With LAEs at Week 156 | Did Not Discontinue With LAEs | 279 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With LAEs at Week 240 | Did Not Discontinue With LAEs | 281 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With LAEs at Week 240 | Discontinued With LAEs | 0 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With LAEs at Week 240 | Discontinued With LAEs | 3 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With LAEs at Week 240 | Did Not Discontinue With LAEs | 279 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With LAEs at Week 96 | Discontinued With LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants Discontinued With LAEs at Week 96 | Did Not Discontinue With LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With LAEs at Week 96 | Discontinued With LAEs | 2 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Discontinued With LAEs at Week 96 | Did Not Discontinue With LAEs | 280 Participants |
Secondary
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
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Died by Week 156 | Died | 4 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Died by Week 156 | Did Not Die | 277 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Died by Week 156 | Died | 1 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Died by Week 156 | Did Not Die | 281 Participants |
Secondary
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
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Died by Week 240 | Died | 5 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Died by Week 240 | Did Not Die | 276 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Died by Week 240 | Died | 5 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Died by Week 240 | Did Not Die | 277 Participants |
Secondary
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
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Died by Week 96 | Died | 3 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Died by Week 96 | Did Not Die | 278 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Died by Week 96 | Died | 0 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Died by Week 96 | Did Not Die | 282 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With CAEs at Week 156 | Discontinued With CAEs | 13 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With CAEs at Week 156 | Did Not Discontinue With CAEs | 268 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With CAEs at Week 156 | Discontinued With CAEs | 21 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With CAEs at Week 156 | Did Not Discontinue With CAEs | 261 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With CAEs at Week 240 | Discontinued With CAEs | 14 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With CAEs at Week 240 | Did Not Discontinue With CAEs | 267 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With CAEs at Week 240 | Discontinued With CAEs | 25 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With CAEs at Week 240 | Did Not Discontinue With CAEs | 257 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With CAEs at Week 96 | Discontinued With CAEs | 10 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With CAEs at Week 96 | Did Not Discontinue With CAEs | 271 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With CAEs at Week 96 | Discontinued With CAEs | 17 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With CAEs at Week 96 | Did Not Discontinue With CAEs | 265 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Drug-related CAEs at Week 156 | Discontinued With Drug-related CAEs | 3 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Drug-related CAEs at Week 156 | Did Not Discontinue With Drug-related CAEs | 278 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Drug-related CAEs at Week 156 | Discontinued With Drug-related CAEs | 14 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Drug-related CAEs at Week 156 | Did Not Discontinue With Drug-related CAEs | 268 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Drug-related CAEs at Week 240 | Discontinued With Drug-related CAEs | 3 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Drug-related CAEs at Week 240 | Did Not Discontinue With Drug-related CAEs | 278 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Drug-related CAEs at Week 240 | Discontinued With Drug-related CAEs | 14 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Drug-related CAEs at Week 240 | Did Not Discontinue With Drug-related CAEs | 268 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Drug-related CAEs at Week 96 | Discontinued With Drug-Related CAEs | 3 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Drug-related CAEs at Week 96 | Did Not Discontinue With Drug-Related CAEs | 278 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Drug-related CAEs at Week 96 | Discontinued With Drug-Related CAEs | 12 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Drug-related CAEs at Week 96 | Did Not Discontinue With Drug-Related CAEs | 270 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious CAEs at Week 156 | Discontinued With Serious CAEs | 10 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious CAEs at Week 156 | Did Not Discontinue With Serious CAEs | 271 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious CAEs at Week 156 | Discontinued With Serious CAEs | 6 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious CAEs at Week 156 | Did Not Discontinue With Serious CAEs | 276 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious CAEs at Week 240 | Discontinued With Serious CAEs | 11 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious CAEs at Week 240 | Did Not Discontinue With Serious CAEs | 270 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious CAEs at Week 240 | Discontinued With Serious CAEs | 10 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious CAEs at Week 240 | Did Not Discontinue With Serious CAEs | 272 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious CAEs at Week 96 | Discontinued With Serious CAEs | 8 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious CAEs at Week 96 | Did Not Discontinue With Serious CAEs | 273 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious CAEs at Week 96 | Discontinued With Serious CAEs | 5 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious CAEs at Week 96 | Did Not Discontinue With Serious CAEs | 277 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 | Discontinued With Serious Drug-related CAEs | 1 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 | Did Not Discontinue With Serious Drug-related CAEs | 280 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 | Discontinued With Serious Drug-related CAEs | 2 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 | Did Not Discontinue With Serious Drug-related CAEs | 280 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 | Discontinued With Serious Drug-related CAEs | 1 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 | Did Not Discontinue With Serious Drug-related CAEs | 280 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 | Discontinued With Serious Drug-related CAEs | 2 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 | Did Not Discontinue With Serious Drug-related CAEs | 280 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 | Discontinued With Serious Drug-related CAEs | 1 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 | Did Not Discontinue With Serious Drug-related CAEs | 280 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 | Discontinued With Serious Drug-related CAEs | 2 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 | Did Not Discontinue With Serious Drug-related CAEs | 280 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156 | 224 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156 | 203 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240 | 206 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240 | 181 Participants |
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.
Time frame: 48 Weeks
Population: All participants who took study medication and had HIV RNA tests performed were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 | 252 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 | 241 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96 | 240 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96 | 229 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156 | 212 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156 | 192 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240 | 198 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240 | 171 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication and had HIV RNA tests performed were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96 | 228 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96 | 222 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With CAEs at Week 156 | With CAEs | 267 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With CAEs at Week 156 | Without CAEs | 14 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With CAEs at Week 156 | With CAEs | 276 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With CAEs at Week 156 | Without CAEs | 6 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With CAEs at Week 240 | With CAEs | 271 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With CAEs at Week 240 | Without CAEs | 10 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With CAEs at Week 240 | With CAEs | 276 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With CAEs at Week 240 | Without CAEs | 6 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With CAEs at Week 96 | With CAEs | 265 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With CAEs at Week 96 | Without CAEs | 16 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With CAEs at Week 96 | With CAEs | 274 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With CAEs at Week 96 | Without CAEs | 8 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related CAEs at Week 156 | With drug-related CAEs | 139 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related CAEs at Week 156 | Without drug-related CAEs | 142 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related CAEs at Week 156 | With drug-related CAEs | 225 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related CAEs at Week 156 | Without drug-related CAEs | 57 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related CAEs at Week 240 | With drug-related CAEs | 146 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related CAEs at Week 240 | Without drug-related CAEs | 135 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related CAEs at Week 240 | With drug-related CAEs | 226 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related CAEs at Week 240 | Without drug-related CAEs | 56 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related CAEs at Week 96 | With drug-related CAEs | 132 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related CAEs at Week 96 | Without drug-related CAEs | 149 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related CAEs at Week 96 | With drug-related CAEs | 220 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related CAEs at Week 96 | Without drug-related CAEs | 62 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related LAEs at Week 156 | Without Drug-related LAEs | 259 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related LAEs at Week 156 | With Drug-related LAEs | 22 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related LAEs at Week 156 | With Drug-related LAEs | 33 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related LAEs at Week 156 | Without Drug-related LAEs | 249 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related LAEs at Week 240 | With Drug-related LAEs | 26 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related LAEs at Week 240 | Without Drug-related LAEs | 255 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related LAEs at Week 240 | With Drug-related LAEs | 43 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related LAEs at Week 240 | Without Drug-related LAEs | 239 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related LAEs at Week 96 | With Drug-related LAEs | 18 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Drug-related LAEs at Week 96 | Without Drug-related LAEs | 263 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related LAEs at Week 96 | With Drug-related LAEs | 29 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Drug-related LAEs at Week 96 | Without Drug-related LAEs | 253 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With LAEs at Week 156 | Without LAEs | 240 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With LAEs at Week 156 | With LAEs | 41 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With LAEs at Week 156 | Without LAEs | 219 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With LAEs at Week 156 | With LAEs | 63 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With LAEs at Week 240 | With LAEs | 56 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With LAEs at Week 240 | Without LAEs | 225 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With LAEs at Week 240 | With LAEs | 77 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With LAEs at Week 240 | Without LAEs | 205 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With LAEs at Week 96 | With LAEs | 33 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With LAEs at Week 96 | Without LAEs | 248 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With LAEs at Week 96 | With LAEs | 53 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With LAEs at Week 96 | Without LAEs | 229 Participants |
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
Time frame: 8 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 | With Nervous System Symptoms | 57 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 | Without Nervous System Symptoms | 224 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 | With Nervous System Symptoms | 147 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 | Without Nervous System Symptoms | 135 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious CAEs at Week 156 | With Serious CAEs | 46 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious CAEs at Week 156 | Without Serious CAEs | 235 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious CAEs at Week 156 | With Serious CAEs | 46 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious CAEs at Week 156 | Without Serious CAEs | 236 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious CAEs at Week 240 | With Serious CAEs | 57 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious CAEs at Week 240 | Without Serious CAEs | 224 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious CAEs at Week 240 | With Serious CAEs | 57 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious CAEs at Week 240 | Without Serious CAEs | 225 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious CAEs at Week 96 | With Serious CAEs | 37 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious CAEs at Week 96 | Without Serious CAEs | 244 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious CAEs at Week 96 | With Serious CAEs | 33 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious CAEs at Week 96 | Without Serious CAEs | 249 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related CAEs at Week 156 | With Serious Drug-related CAEs | 6 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related CAEs at Week 156 | Without Serious Drug-related CAEs | 275 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related CAEs at Week 156 | With Serious Drug-related CAEs | 6 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related CAEs at Week 156 | Without Serious Drug-related CAEs | 276 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related CAEs at Week 240 | With Serious Drug-related CAEs | 8 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related CAEs at Week 240 | Without Serious Drug-related CAEs | 273 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related CAEs at Week 240 | With Serious Drug-related CAEs | 7 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related CAEs at Week 240 | Without Serious Drug-related CAEs | 275 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related CAEs at Week 96 | With Serious Drug-related CAEs | 6 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related CAEs at Week 96 | Without Serious Drug-related CAEs | 275 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related CAEs at Week 96 | With Serious Drug-related CAEs | 5 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related CAEs at Week 96 | Without Serious Drug-related CAEs | 277 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related LAEs at Week 156 | With Serious Drug-related CAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related LAEs at Week 156 | Without Serious Drug-related CAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related LAEs at Week 156 | With Serious Drug-related CAEs | 1 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related LAEs at Week 156 | Without Serious Drug-related CAEs | 281 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related LAEs at Week 240 | With Serious Drug-related LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related LAEs at Week 240 | Without Serious Drug-related LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related LAEs at Week 240 | With Serious Drug-related LAEs | 1 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related LAEs at Week 240 | Without Serious Drug-related LAEs | 281 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related LAEs at Week 96 | With Serious Drug-related CAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious Drug-related LAEs at Week 96 | Without Serious Drug-related CAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related LAEs at Week 96 | With Serious Drug-related CAEs | 0 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious Drug-related LAEs at Week 96 | Without Serious Drug-related CAEs | 282 Participants |
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.
Time frame: 156 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious LAEs at Week 156 | With Serious LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious LAEs at Week 156 | Without Serious LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious LAEs at Week 156 | With Serious LAEs | 2 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious LAEs at Week 156 | Without Serious LAEs | 280 Participants |
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.
Time frame: 240 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious LAEs at Week 240 | With Serious LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious LAEs at Week 240 | Without Serious LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious LAEs at Week 240 | Without Serious LAEs | 280 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious LAEs at Week 240 | With Serious LAEs | 2 Participants |
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.
Time frame: 96 Weeks
Population: All participants who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MK-0518 400 mg b.i.d. | Number of Participants With Serious LAEs at Week 96 | With Serious LAEs | 0 Participants |
| MK-0518 400 mg b.i.d. | Number of Participants With Serious LAEs at Week 96 | Without Serious LAEs | 281 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious LAEs at Week 96 | With Serious LAEs | 1 Participants |
| Efavirenz 600 mg q.h.s. | Number of Participants With Serious LAEs at Week 96 | Without Serious LAEs | 281 Participants |