<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01717287</url>
  </required_header>
  <id_info>
    <org_study_id>0518-248</org_study_id>
    <nct_id>NCT01717287</nct_id>
  </id_info>
  <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)</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Covance</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multicenter, open-label, noncomparative study evaluates two oral formulations of&#xD;
      raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other&#xD;
      antiretroviral agents for safety, tolerability, and antiretroviral activity in&#xD;
      treatment-naive or treatment-experienced Russian children and adolescents infected with human&#xD;
      immunodeficiency virus-1 (HIV-1).&#xD;
&#xD;
      As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the&#xD;
      treatment of HIV-1 infection in pediatric patients in the United States (US), this study is&#xD;
      designed to gain local treatment experience on the use&#xD;
&#xD;
      of raltegravir in the pediatric HIV-infected population in Russia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2012</start_date>
  <completion_date type="Actual">December 11, 2013</completion_date>
  <primary_completion_date type="Actual">December 11, 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With at Least One Clinical Adverse Experience</measure>
    <time_frame>Up to Week 26</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience</measure>
    <time_frame>Up to Week 24</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With at Least One Laboratory Adverse Experience</measure>
    <time_frame>Up to Week 26</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience</measure>
    <time_frame>Up to Week 24</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>This outcome is a measure of immunological response to treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CD4 Cell Percentage</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>This outcome is a measure of immunological response to treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving &gt;=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of &lt;200 Copies/mL</measure>
    <time_frame>Week 24</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving HIV RNA &lt;40 Copies/mL</measure>
    <time_frame>Week 24</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving HIV RNA &lt;200 Copies/mL</measure>
    <time_frame>Week 24</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>HIV Infection</condition>
  <arm_group>
    <arm_group_label>Raltegravir Film-coated Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Raltegravir Chewable Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Raltegravir Film-coated Tablet</intervention_name>
    <arm_group_label>Raltegravir Film-coated Tablet</arm_group_label>
    <other_name>ISENTRESS®</other_name>
    <other_name>MK-0518</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Raltegravir Chewable Tablet</intervention_name>
    <arm_group_label>Raltegravir Chewable Tablet</arm_group_label>
    <other_name>ISENTRESS®</other_name>
    <other_name>MK-0518</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Other Anti-Retroviral Therapy</intervention_name>
    <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</description>
    <arm_group_label>Raltegravir Chewable Tablet</arm_group_label>
    <arm_group_label>Raltegravir Film-coated Tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  Weight of at least 7 kg&#xD;
&#xD;
          -  HIV RNA ≥1000 copies/mL within 45 days before study treatment&#xD;
&#xD;
          -  Participants of reproductive potential and sexually active agree to remain&#xD;
&#xD;
        abstinent or use (or have their partner use) an acceptable method of birth control&#xD;
        throughout the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females pregnant or breast-feeding, or expecting to conceive or donate eggs&#xD;
&#xD;
        during the study; males planning to impregnate or provide sperm donation&#xD;
&#xD;
        during the study&#xD;
&#xD;
          -  Use of any non-antiretroviral (ART) investigational agents within one month before&#xD;
             study treatment&#xD;
&#xD;
          -  Current (active) diagnosis of acute hepatitis or chronic hepatitis other than stable&#xD;
             chronic Hepatitis B and/or C&#xD;
&#xD;
          -  Prior or current use of raltegravir&#xD;
&#xD;
          -  Use of another experimental HIV-integrase inhibitor&#xD;
&#xD;
          -  History or current evidence of any condition, therapy, laboratory&#xD;
&#xD;
        abnormality, or other circumstance that might confound the results of the study, or&#xD;
        interfere with participation for the full duration of the study&#xD;
&#xD;
          -  Requires or is anticipated to require any prohibited medications&#xD;
&#xD;
          -  Use of immunosuppressive therapy within 30 days before beginning&#xD;
&#xD;
        raltegravir study treatment; short courses of corticosteroids are permitted.&#xD;
&#xD;
          -  History of malignancy&#xD;
&#xD;
          -  Current treatment for active tuberculosis infection&#xD;
&#xD;
          -  Use of recreational or illicit drugs or a recent history (within the&#xD;
&#xD;
        last year) of drug or alcohol abuse or dependence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Russian Federation</country>
  </removed_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>June 30, 2014</results_first_submitted>
  <results_first_submitted_qc>June 30, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 29, 2014</results_first_posted>
  <last_update_submitted>July 23, 2018</last_update_submitted>
  <last_update_submitted_qc>July 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Raltegravir Potassium</mesh_term>
    <mesh_term>Anti-Retroviral Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>CSR Synopsis</doc_type>
      <doc_url>http://www.merck.com/clinical-trials/study.html?id=0518-248&amp;kw=0518-248&amp;tab=access</doc_url>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Film-coated tablets were administered to participants &gt;=12 years old and to those 6 to &lt;12 years old who weighed &gt;=25 kg and could swallow pills. A weight-based dose of chewable tablets was administered to participants 6 to &lt;12 years old who could not swallow pills or preferred the chewable formulation, and to participants 2 to &lt;6 years old</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Raltegravir Film-coated Tablet</title>
          <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Raltegravir Chewable Tablet</title>
          <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</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Raltegravir Film-coated Tablet</title>
          <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Raltegravir Chewable Tablet</title>
          <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</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>2 to &lt;6 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 to &lt;12 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 to &lt;18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least One Clinical Adverse Experience</title>
        <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.</description>
        <time_frame>Up to Week 26</time_frame>
        <population>All patients as treated population included all enrolled participants who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir Film-coated Tablet</title>
            <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Raltegravir Chewable Tablet</title>
            <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</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Clinical Adverse Experience</title>
          <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.</description>
          <population>All patients as treated population included all enrolled participants who received at least one dose of study drug</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="42.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience</title>
        <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.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>All patients as treated population included all enrolled participants who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir Film-coated Tablet</title>
            <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Raltegravir Chewable Tablet</title>
            <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</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience</title>
          <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.</description>
          <population>All patients as treated population included all enrolled participants who received at least one dose of study drug</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count</title>
        <description>This outcome is a measure of immunological response to treatment</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir Film-coated Tablet</title>
            <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Raltegravir Chewable Tablet</title>
            <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</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count</title>
          <description>This outcome is a measure of immunological response to treatment</description>
          <population>The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation</population>
          <units>cells/mm^3</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.3" lower_limit="-178.6" upper_limit="239.2"/>
                    <measurement group_id="O2" value="296.3" lower_limit="133.6" upper_limit="458.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CD4 Cell Percentage</title>
        <description>This outcome is a measure of immunological response to treatment</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir Film-coated Tablet</title>
            <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Raltegravir Chewable Tablet</title>
            <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</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CD4 Cell Percentage</title>
          <description>This outcome is a measure of immunological response to treatment</description>
          <population>The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation</population>
          <units>Percentage change</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="-5.0" upper_limit="13.0"/>
                    <measurement group_id="O2" value="6.0" lower_limit="3.8" upper_limit="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least One Laboratory Adverse Experience</title>
        <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.</description>
        <time_frame>Up to Week 26</time_frame>
        <population>All patients as treated population included all enrolled participants who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir Film-coated Tablet</title>
            <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Raltegravir Chewable Tablet</title>
            <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</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Laboratory Adverse Experience</title>
          <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.</description>
          <population>All patients as treated population included all enrolled participants who received at least one dose of study drug</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience</title>
        <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.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>All patients as treated population included all enrolled participants who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir Film-coated Tablet</title>
            <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Raltegravir Chewable Tablet</title>
            <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</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience</title>
          <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.</description>
          <population>All patients as treated population included all enrolled participants who received at least one dose of study drug</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving &gt;=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of &lt;200 Copies/mL</title>
        <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</description>
        <time_frame>Week 24</time_frame>
        <population>Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had at least one postbaseline evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir Film-coated Tablet</title>
            <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Raltegravir Chewable Tablet</title>
            <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</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving &gt;=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of &lt;200 Copies/mL</title>
          <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</description>
          <population>Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had at least one postbaseline evaluation</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="19.4" upper_limit="99.4"/>
                    <measurement group_id="O2" value="88.0" lower_limit="68.8" upper_limit="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving HIV RNA &lt;40 Copies/mL</title>
        <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</description>
        <time_frame>Week 24</time_frame>
        <population>Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir Film-coated Tablet</title>
            <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Raltegravir Chewable Tablet</title>
            <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</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving HIV RNA &lt;40 Copies/mL</title>
          <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</description>
          <population>Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="6.8" upper_limit="93.2"/>
                    <measurement group_id="O2" value="44.0" lower_limit="24.4" upper_limit="65.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving HIV RNA &lt;200 Copies/mL</title>
        <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</description>
        <time_frame>Week 24</time_frame>
        <population>Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir Film-coated Tablet</title>
            <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks</description>
          </group>
          <group group_id="O2">
            <title>Raltegravir Chewable Tablet</title>
            <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</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving HIV RNA &lt;200 Copies/mL</title>
          <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</description>
          <population>Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="6.8" upper_limit="93.2"/>
                    <measurement group_id="O2" value="76.0" lower_limit="54.9" upper_limit="90.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 26</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Raltegravir Film-coated Tablet</title>
          <description>Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Raltegravir Chewable Tablet</title>
          <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</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717287
org study id: 0518-248
nct id: NCT01717287
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With at Least One Clinical Adverse Experience
time frame: Up to Week 26
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.
measure: Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience
time frame: Up to Week 24
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.
measure: Percentage of Participants With at Least One Laboratory Adverse Experience
time frame: Up to Week 26
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.
measure: Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience
time frame: Up to Week 24
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.
measure: Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
time frame: Baseline and Week 24
description: This outcome is a measure of immunological response to treatment
measure: Change From Baseline in CD4 Cell Percentage
time frame: Baseline and Week 24
description: This outcome is a measure of immunological response to treatment
measure: 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
time frame: Week 24
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
measure: Percentage of Participants Achieving HIV RNA <40 Copies/mL
time frame: Week 24
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
measure: Percentage of Participants Achieving HIV RNA <200 Copies/mL
time frame: Week 24
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
arm group label: Raltegravir Film-coated Tablet
arm group type: Experimental
description: Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
arm group label: Raltegravir Chewable Tablet
arm group type: Experimental
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: Raltegravir Film-coated Tablet
arm group label: Raltegravir Film-coated Tablet
other name: ISENTRESS®
other name: MK-0518
intervention type: Drug
intervention name: Raltegravir Chewable Tablet
arm group label: Raltegravir Chewable Tablet
other name: ISENTRESS®
other name: MK-0518
intervention type: Drug
intervention name: Other Anti-Retroviral Therapy
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
arm group label: Raltegravir Chewable Tablet
arm group label: Raltegravir Film-coated Tablet
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Russian Federation
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Raltegravir Potassium
mesh term: Anti-Retroviral Agents
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
study doc: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 