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Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)

Primary Purpose

HIV Infections, Acquired Immunodeficiency Syndrome

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: MK0518
MK0518
MK0518
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study Patient must be currently on antiretroviral therapy (ART) Exclusion Criteria: Patient less than 18 years of age Additional exclusion criteria will be discussed and identified by the study doctor

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    MK0518 200 mg

    MK0518 400 mg

    MK0518 600 mg

    Placebo

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
    Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients

    Secondary Outcome Measures

    Number of Patients With Virologic Responses at Week 24
    Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24
    Change From Baseline in CD4 Cell Count at Week 24
    Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)
    Number of Patients With Clinical Adverse Experiences (CAEs) at 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 SPONSOR'S product, whether or not considered related to the use of the product
    Number of Patients With Serious CAEs at 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 Patients With Drug-related CAEs at 48 Weeks
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
    Number of Patients With Serious Drug-related CAEs at 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
    Number of Patients That Died by 48 Weeks
    Number of Patients That Discontinued With CAEs at 48 Weeks
    Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks
    Number of Patients That Discontinued With Serious CAEs at 48 Weeks
    Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks
    Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Number of Patients With Drug-related LAEs at 48 Weeks
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
    Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks
    Number of Patients Discontinued With Drug-related LAEs at 48 Weeks
    Number of Patients With Clinical Adverse Experiences (CAEs) at 96 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 SPONSOR'S product, whether or not considered related to the use of the product
    Number of Patients With Serious CAEs at 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 Patients With Drug-related CAEs at 96 Weeks
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
    Number of Patients With Serious Drug-related CAEs at 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
    Number of Patients That Died by 96 Weeks
    Number of Patients That Discontinued With CAEs at 96 Weeks
    Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks
    Number of Patients That Discontinued With Serious CAEs at 96 Weeks
    Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks
    Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Number of Patients With Drug-related LAEs at 96 Weeks
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
    Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks
    Number of Patients Discontinued With Drug-related LAEs at 96 Weeks
    Number of Patients With Clinical Adverse Experiences (CAEs) at 168 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 SPONSOR'S product, whether or not considered related to the use of the product
    Number of Patients With Serious CAEs at 168 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 Patients With Drug-related CAEs at 168 Weeks
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
    Number of Patients With Serious Drug-related CAEs at 168 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
    Number of Patients That Died by 168 Weeks
    Number of Patients That Discontinued With CAEs at 168 Weeks
    Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks
    Number of Patients That Discontinued With Serious CAEs at 168 Weeks
    Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks
    Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Number of Patients With Serious LAEs at 168 Weeks
    Serious LAEs are any LAEs 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 Patients Discontinued With Drug-related LAEs at 168 Weeks
    Number of Patients With Drug-related LAEs at 168 Weeks
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
    Number of Patients With Serious Drug-related LAEs at 168 Weeks
    Serious LAEs are any LAEs 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 Patients Discontinued With LAEs at 168 Weeks

    Full Information

    First Posted
    March 8, 2005
    Last Updated
    December 3, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00105157
    Brief Title
    Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)
    Official Title
    Multicenter Study to Evaluate the Safety and Efficacy of MK0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    October 2006 (Actual)
    Study Completion Date
    July 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections, Acquired Immunodeficiency Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    179 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MK0518 200 mg
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    MK0518 400 mg
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    MK0518 600 mg
    Arm Title
    4
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: MK0518
    Other Intervention Name(s)
    MK0518
    Intervention Description
    MK0518 oral tablets 200 mg b.i.d, for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    MK0518
    Intervention Description
    MK0518 oral tablets 400 mg b.i.d, for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    MK0518
    Intervention Description
    MK0518 oral tablets 600 mg b.i.d, for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo to MK0518, oral tablet b.i.d, for 24 weeks
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
    Description
    Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients
    Time Frame
    Baseline and Week 24
    Secondary Outcome Measure Information:
    Title
    Number of Patients With Virologic Responses at Week 24
    Description
    Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24
    Time Frame
    24 weeks
    Title
    Change From Baseline in CD4 Cell Count at Week 24
    Description
    Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)
    Time Frame
    Baseline and Week 24
    Title
    Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks
    Description
    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 SPONSOR'S product, whether or not considered related to the use of the product
    Time Frame
    48 weeks
    Title
    Number of Patients With Serious CAEs at 48 Weeks
    Description
    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
    Title
    Number of Patients With Drug-related CAEs at 48 Weeks
    Description
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
    Time Frame
    48 weeks
    Title
    Number of Patients With Serious Drug-related CAEs at 48 Weeks
    Description
    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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
    Time Frame
    48 weeks
    Title
    Number of Patients That Died by 48 Weeks
    Time Frame
    48 weeks
    Title
    Number of Patients That Discontinued With CAEs at 48 Weeks
    Time Frame
    48 weeks
    Title
    Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks
    Time Frame
    48 weeks
    Title
    Number of Patients That Discontinued With Serious CAEs at 48 Weeks
    Time Frame
    48 weeks
    Title
    Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks
    Time Frame
    48 weeks
    Title
    Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks
    Description
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Time Frame
    48 weeks
    Title
    Number of Patients With Drug-related LAEs at 48 Weeks
    Description
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
    Time Frame
    48 weeks
    Title
    Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks
    Time Frame
    48 weeks
    Title
    Number of Patients Discontinued With Drug-related LAEs at 48 Weeks
    Time Frame
    48 weeks
    Title
    Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks
    Description
    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 SPONSOR'S product, whether or not considered related to the use of the product
    Time Frame
    96 weeks
    Title
    Number of Patients With Serious CAEs at 96 Weeks
    Description
    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
    Title
    Number of Patients With Drug-related CAEs at 96 Weeks
    Description
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
    Time Frame
    96 weeks
    Title
    Number of Patients With Serious Drug-related CAEs at 96 Weeks
    Description
    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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
    Time Frame
    96 weeks
    Title
    Number of Patients That Died by 96 Weeks
    Time Frame
    96 weeks
    Title
    Number of Patients That Discontinued With CAEs at 96 Weeks
    Time Frame
    96 weeks
    Title
    Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks
    Time Frame
    96 weeks
    Title
    Number of Patients That Discontinued With Serious CAEs at 96 Weeks
    Time Frame
    96 weeks
    Title
    Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks
    Time Frame
    96 weeks
    Title
    Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks
    Description
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Time Frame
    96 weeks
    Title
    Number of Patients With Drug-related LAEs at 96 Weeks
    Description
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
    Time Frame
    96 weeks
    Title
    Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks
    Time Frame
    96 weeks
    Title
    Number of Patients Discontinued With Drug-related LAEs at 96 Weeks
    Time Frame
    96 weeks
    Title
    Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks
    Description
    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 SPONSOR'S product, whether or not considered related to the use of the product
    Time Frame
    168 weeks
    Title
    Number of Patients With Serious CAEs at 168 Weeks
    Description
    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
    168 weeks
    Title
    Number of Patients With Drug-related CAEs at 168 Weeks
    Description
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
    Time Frame
    168 weeks
    Title
    Number of Patients With Serious Drug-related CAEs at 168 Weeks
    Description
    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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
    Time Frame
    168 weeks
    Title
    Number of Patients That Died by 168 Weeks
    Time Frame
    168 weeks
    Title
    Number of Patients That Discontinued With CAEs at 168 Weeks
    Time Frame
    168 weeks
    Title
    Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks
    Time Frame
    168 weeks
    Title
    Number of Patients That Discontinued With Serious CAEs at 168 Weeks
    Time Frame
    168 weeks
    Title
    Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks
    Time Frame
    168 weeks
    Title
    Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks
    Description
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
    Time Frame
    168 weeks
    Title
    Number of Patients With Serious LAEs at 168 Weeks
    Description
    Serious LAEs are any LAEs 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
    168 weeks
    Title
    Number of Patients Discontinued With Drug-related LAEs at 168 Weeks
    Time Frame
    168 weeks
    Title
    Number of Patients With Drug-related LAEs at 168 Weeks
    Description
    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
    Time Frame
    168 weeks
    Title
    Number of Patients With Serious Drug-related LAEs at 168 Weeks
    Description
    Serious LAEs are any LAEs 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
    168 weeks
    Title
    Number of Patients Discontinued With LAEs at 168 Weeks
    Time Frame
    168 weeks
    Other Pre-specified Outcome Measures:
    Title
    Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies
    Description
    Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases.
    Time Frame
    Baseline and Week 168
    Title
    Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies
    Description
    Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases.
    Time Frame
    Baseline and Week 168

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study Patient must be currently on antiretroviral therapy (ART) Exclusion Criteria: Patient less than 18 years of age Additional exclusion criteria will be discussed and identified by the study doctor
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17434401
    Citation
    Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-1269. doi: 10.1016/S0140-6736(07)60597-2.
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    Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)

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