Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00369941
First received: August 29, 2006
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: MK-0518
Drug: Comparator: efavirenz
Drug: Comparator: Truvada
Drug: Comparator: Placebo to MK-0518
Drug: Comparator: Placebo to efavirenz
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    All participant deaths in the span of 48 weeks on study were recorded.

  • Number of Participants That Discontinued With CAEs at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48.

  • Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 96 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 156 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 240 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
    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 156 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
    All participant deaths in the span of 96 weeks on study were recorded.

  • Number of Participants That Died by Week 156 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]
    All participant deaths in the span of 156 weeks on study were recorded.

  • Number of Participants That Died by Week 240 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]
    All participant deaths in the span of 240 weeks on study were recorded.

  • Number of Participants That Discontinued With CAEs at Week 96 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]

    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 156 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 156 Weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 566
Study Start Date: August 2006
Study Completion Date: February 2012
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: MK-0518
400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks
Other Names:
  • raltegravir
  • Isentress®
Drug: Comparator: Truvada
One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)
Other Name: emtricitabine/tenofovir disoproxil fumarate
Drug: Comparator: Placebo to efavirenz
Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks
Active Comparator: 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.
Drug: Comparator: efavirenz
600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks
Other Name: Sustiva®
Drug: Comparator: Truvada
One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)
Other Name: emtricitabine/tenofovir disoproxil fumarate
Drug: Comparator: Placebo to MK-0518
Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369941

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00369941     History of Changes
Other Study ID Numbers: 0518-021, MK-0518-021, 2006_519
Study First Received: August 29, 2006
Results First Received: September 18, 2009
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Efavirenz
Emtricitabine
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014