<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/NCT02203461</url>
  </required_header>
  <id_info>
    <org_study_id>STR-1383--0030-I</org_study_id>
    <secondary_id>2014-000359-98</secondary_id>
    <nct_id>NCT02203461</nct_id>
  </id_info>
  <brief_title>Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication</brief_title>
  <official_title>Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>MUC Research GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Technical University of Munich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after&#xD;
      14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by&#xD;
      hyperinsulinemic euglycemic clamp.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The measurement of insulin resistance will be performed in 30 HIV-negative healthy non-obese&#xD;
      (BMI 18-25) male volunteers before and after 14 days (+/- 2 days) of treatment with STRIBILD®&#xD;
      (treatment 1, n=10), as compared to TVD, LPV/r (treatment 2, n=10) and TVD, DRV/r (treatment&#xD;
      3, n=10). The volunteers will be randomly assigned to one of three groups. The measurement of&#xD;
      insulin resistance, lipid and glucose metabolism will be performed; before and immediately&#xD;
      after the treatment. Furthermore, the therapy compliance will be verified using the method of&#xD;
      drug counting and therapeutic drug monitoring (TDM).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp</measure>
    <time_frame>Day 14</time_frame>
    <description>Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in metabolic parameters</measure>
    <time_frame>Day 14</time_frame>
    <description>Changes in lipid, metabolic hormons and &quot;HOMA-IR&quot;, &quot;Homa-beta&quot;, &quot;QUICKIE&quot; test.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat</intervention_name>
    <description>STRIBILD® QD, d1-14</description>
    <arm_group_label>Group I</arm_group_label>
    <other_name>STRIBILD®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir</intervention_name>
    <description>Truvada®/ Kaletra® 200/50 mg QD, d1-14</description>
    <arm_group_label>Group II</arm_group_label>
    <other_name>Truvada® / Kaletra®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir</intervention_name>
    <description>Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14</description>
    <arm_group_label>Group III</arm_group_label>
    <other_name>Truvada®/Prezista®/Norvir®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male volunteers, age 18-40 years&#xD;
&#xD;
          -  Informed consent and willingness in study participation&#xD;
&#xD;
          -  Birth control during study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in other clinical trials&#xD;
&#xD;
          -  Contraindication or known allergy to study medication&#xD;
&#xD;
          -  Known metabolic disease incl. Diabetes mellitus, Hypertriglyceridemia or others&#xD;
&#xD;
          -  Known alcohol or nicotine abuse&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  History of pharmaceutical study in the last 4 weeks&#xD;
&#xD;
          -  BMI &lt; 18 &gt; 25&#xD;
&#xD;
          -  Long-term or regular medication&#xD;
&#xD;
          -  Known liver-, renal-, cardiovascular, lung, gastrointestinal, endocrine, neurologic,&#xD;
             psychiatric or metabolic disorder&#xD;
&#xD;
          -  Dependence to study center or coordinator&#xD;
&#xD;
          -  Inmates or psychiatric treatment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoph D Spinner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Klinikum rechts der Isar (TUM)</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>November 4, 2014</last_update_submitted>
  <last_update_submitted_qc>November 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ART, HIV, insulin resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Lopinavir</mesh_term>
    <mesh_term>Darunavir</mesh_term>
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Emtricitabine</mesh_term>
    <mesh_term>Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
    <mesh_term>Cobicistat</mesh_term>
    <mesh_term>Elvitegravir</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02203461
org study id: STR-1383--0030-I
secondary id: 2014-000359-98
nct id: NCT02203461
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after
      14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by
      hyperinsulinemic euglycemic clamp.
The measurement of insulin resistance will be performed in 30 HIV-negative healthy non-obese
      (BMI 18-25) male volunteers before and after 14 days (+/- 2 days) of treatment with STRIBILD®
      (treatment 1, n=10), as compared to TVD, LPV/r (treatment 2, n=10) and TVD, DRV/r (treatment
      3, n=10). The volunteers will be randomly assigned to one of three groups. The measurement of
      insulin resistance, lipid and glucose metabolism will be performed; before and immediately
      after the treatment. Furthermore, the therapy compliance will be verified using the method of
      drug counting and therapeutic drug monitoring (TDM).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp
time frame: Day 14
description: Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.
measure: Changes in metabolic parameters
time frame: Day 14
description: Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test.
arm group label: Group I
arm group type: Experimental
description: STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
arm group label: Group II
arm group type: Active Comparator
description: Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
arm group label: Group III
arm group type: Experimental
description: Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
intervention type: Drug
intervention name: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
description: STRIBILD® QD, d1-14
arm group label: Group I
other name: STRIBILD®
intervention type: Drug
intervention name: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
description: Truvada®/ Kaletra® 200/50 mg QD, d1-14
arm group label: Group II
other name: Truvada® / Kaletra®
intervention type: Drug
intervention name: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
description: Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14
arm group label: Group III
other name: Truvada®/Prezista®/Norvir®
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christoph D Spinner, MD
role: Principal Investigator
affiliation: University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Insulin Resistance
mesh term: Ritonavir
mesh term: Lopinavir
mesh term: Darunavir
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
mesh term: Cobicistat
mesh term: Elvitegravir