Clinical Trials

MainTitle

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
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT00369941

First received: August 29, 2006
Last updated: February 14, 2017
Last Verified: February 2017
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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™

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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 Name:
  • 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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

More Information


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  
Last Updated: February 14, 2017  
Individual Participant Data    
Plan to Share IPD: Yes  

Additional relevant MeSH terms:
HIV Infections
Tenofovir
Emtricitabine
Efavirenz
Raltegravir Potassium
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.