search
Back to results

A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Raltegravir Film-coated Tablet
Raltegravir Chewable Tablet
Other Anti-Retroviral Therapy
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV positive
  • Weight of at least 7 kg
  • HIV RNA ≥1000 copies/mL within 45 days before study treatment
  • Participants of reproductive potential and sexually active agree to remain

abstinent or use (or have their partner use) an acceptable method of birth control throughout the study.

Exclusion Criteria:

  • Females pregnant or breast-feeding, or expecting to conceive or donate eggs

during the study; males planning to impregnate or provide sperm donation

during the study

  • Use of any non-antiretroviral (ART) investigational agents within one month before study treatment
  • Current (active) diagnosis of acute hepatitis or chronic hepatitis other than stable chronic Hepatitis B and/or C
  • Prior or current use of raltegravir
  • Use of another experimental HIV-integrase inhibitor
  • History or current evidence of any condition, therapy, laboratory

abnormality, or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study

  • Requires or is anticipated to require any prohibited medications
  • Use of immunosuppressive therapy within 30 days before beginning

raltegravir study treatment; short courses of corticosteroids are permitted.

  • History of malignancy
  • Current treatment for active tuberculosis infection
  • Use of recreational or illicit drugs or a recent history (within the

last year) of drug or alcohol abuse or dependence

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Raltegravir Film-coated Tablet

    Raltegravir Chewable Tablet

    Arm Description

    Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks

    Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With at Least One Clinical Adverse Experience
    A clinical adverse experience 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. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
    Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience
    A clinical adverse experience 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. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
    Percentage of Participants With at Least One Laboratory Adverse Experience
    A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
    Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience
    A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.

    Secondary Outcome Measures

    Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
    This outcome is a measure of immunological response to treatment
    Change From Baseline in CD4 Cell Percentage
    This outcome is a measure of immunological response to treatment
    Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL
    This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
    Percentage of Participants Achieving HIV RNA <40 Copies/mL
    This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
    Percentage of Participants Achieving HIV RNA <200 Copies/mL
    This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL

    Full Information

    First Posted
    October 26, 2012
    Last Updated
    July 23, 2018
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Covance
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01717287
    Brief Title
    A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)
    Official Title
    A Phase II, Multicenter, Open-Label, Noncomparative Study of Raltegravir (MK-0518) in Two Oral Formulations in Combination With Other Antiretroviral Agents to Evaluate the Safety, Tolerability, and Antiretroviral Activity in HIV-1 Infected Russian Children and Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 16, 2012 (Actual)
    Primary Completion Date
    December 11, 2013 (Actual)
    Study Completion Date
    December 11, 2013 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and antiretroviral activity in treatment-naive or treatment-experienced Russian children and adolescents infected with human immunodeficiency virus-1 (HIV-1). As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the treatment of HIV-1 infection in pediatric patients in the United States (US), this study is designed to gain local treatment experience on the use of raltegravir in the pediatric HIV-infected population in Russia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Raltegravir Film-coated Tablet
    Arm Type
    Experimental
    Arm Description
    Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
    Arm Title
    Raltegravir Chewable Tablet
    Arm Type
    Experimental
    Arm Description
    Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Raltegravir Film-coated Tablet
    Other Intervention Name(s)
    ISENTRESS®, MK-0518
    Intervention Type
    Drug
    Intervention Name(s)
    Raltegravir Chewable Tablet
    Other Intervention Name(s)
    ISENTRESS®, MK-0518
    Intervention Type
    Drug
    Intervention Name(s)
    Other Anti-Retroviral Therapy
    Intervention Description
    At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With at Least One Clinical Adverse Experience
    Description
    A clinical adverse experience 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. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
    Time Frame
    Up to Week 26
    Title
    Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience
    Description
    A clinical adverse experience 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. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
    Time Frame
    Up to Week 24
    Title
    Percentage of Participants With at Least One Laboratory Adverse Experience
    Description
    A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
    Time Frame
    Up to Week 26
    Title
    Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience
    Description
    A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
    Time Frame
    Up to Week 24
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
    Description
    This outcome is a measure of immunological response to treatment
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline in CD4 Cell Percentage
    Description
    This outcome is a measure of immunological response to treatment
    Time Frame
    Baseline and Week 24
    Title
    Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL
    Description
    This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
    Time Frame
    Week 24
    Title
    Percentage of Participants Achieving HIV RNA <40 Copies/mL
    Description
    This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
    Time Frame
    Week 24
    Title
    Percentage of Participants Achieving HIV RNA <200 Copies/mL
    Description
    This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
    Time Frame
    Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV positive Weight of at least 7 kg HIV RNA ≥1000 copies/mL within 45 days before study treatment Participants of reproductive potential and sexually active agree to remain abstinent or use (or have their partner use) an acceptable method of birth control throughout the study. Exclusion Criteria: Females pregnant or breast-feeding, or expecting to conceive or donate eggs during the study; males planning to impregnate or provide sperm donation during the study Use of any non-antiretroviral (ART) investigational agents within one month before study treatment Current (active) diagnosis of acute hepatitis or chronic hepatitis other than stable chronic Hepatitis B and/or C Prior or current use of raltegravir Use of another experimental HIV-integrase inhibitor History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study Requires or is anticipated to require any prohibited medications Use of immunosuppressive therapy within 30 days before beginning raltegravir study treatment; short courses of corticosteroids are permitted. History of malignancy Current treatment for active tuberculosis infection Use of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse or dependence
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=0518-248&kw=0518-248&tab=access

    Learn more about this trial

    A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)

    We'll reach out to this number within 24 hrs