<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/NCT03754803</url>
  </required_header>
  <id_info>
    <org_study_id>208983</org_study_id>
    <nct_id>NCT03754803</nct_id>
  </id_info>
  <brief_title>Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany</brief_title>
  <acronym>URBAN</acronym>
  <official_title>Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ViiV Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MUC Research GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ViiV Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, non-interventional, multi-center study, in subjects with clinical&#xD;
      indication of Human Immunodeficiency Virus (HIV)-1 infection. The aim of the study is to&#xD;
      generate the real world evidence for the use of DTG+3TC in routine clinical care in Germany&#xD;
      to supplement data obtained from controlled clinical trials. Approximately, 300 treatment&#xD;
      naïve and pre-treated HIV-1 positive subjects will be enrolled in the study. The observation&#xD;
      period for the study will be 3 years. Data will be collected from routine clinical care via&#xD;
      electronic data capture (EDC) system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 8, 2018</start_date>
  <completion_date type="Anticipated">August 25, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 7, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of subjects with sustained virologic suppression, with Viral load (VL) &lt; 50 Copies per Milliliter (c/mL)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Percentage of subjects with sustained virologic suppression, defined as VL &lt;50 c/mL or if between 50-200 c/mL with a subsequent next available measurement &lt;50 c/mL (within 120 days) will be evaluated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of pre-treated subjects with low level viremia</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Percentage of subjects with low level viremia, defined as a VL measurement between &gt;50 to &lt;200 c/mL for pre-treated subjects will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of naïve subjects with low level viremia after initial suppression</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Percentage of subjects with low level viremia, defined as a VL measurement between &gt;50 to &lt;200 c/mL after initial suppression of &lt;50 c/mL for naïve subjects will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of virologic non-responders for naïve subjects</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Percentage of virologic non-responders, defined as two consecutive measurements &gt;=200 c/mL after at least 24 weeks of treatment in naïve subjects will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of naïve subjects with virologic rebound</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Percentage of naïve subjects with virologic rebound, defined as two consecutive VL measurements &gt;=200 c/mL after suppression (one VL &lt;50 c/mL) will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with VL &lt; 50 c/mL</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Percentage of subjects with VL &lt;50 c/mL will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with two consecutive VL measurements of &gt;=200 c/mL</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Percentage of subjects with two consecutive VL measurements of &gt;=200 c/mL will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with treatment switch</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Percentage of subjects with treatment switch due to virologic failure (VF) or due to intolerability determined at the discretion of the physician will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with VL &gt; 50 c/mL with emergent resistance mutations</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Percentage of subjects with VL &gt;50 c/mL with emergent resistance mutations will be summarized. Resistance analysis will be performed at the physician's discretion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of monitoring measures</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Number of monitoring measures (normalized to subject years) will be summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and frequency of serious adverse events (SAE)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and frequency of adverse drug reactions (ADRs)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, that is the relationship cannot be ruled out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to therapy</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Adherence to therapy will be determined from the number of monthly doses missed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline for lipid laboratory parameter: lactate dehydrogenase (LDH)</measure>
    <time_frame>Baseline and up to 36 months</time_frame>
    <description>Lipid laboratory parameter LDH data will be evaluated at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline for lipid laboratory parameters: cholesterol and triglycerides</measure>
    <time_frame>Baseline and up to 36 months</time_frame>
    <description>Lipid laboratory parameters cholesterol and triglycerides data will be evaluated at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in treatment satisfaction based on HIV Treatment Satisfaction questionnaire (HIV TSQ)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility. In treatment satisfaction score will range from 0-60, higher the score, greater the satisfaction with treatment. Individual item scores which included All rate score ranging from 0 (very dissatisfied, inconvenient, inflexible) to 6 (very satisfied, convenient, flexible), in case of general satisfaction , there will be 10 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale. For lifestyle scale with 8 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Distress based on HIV Symptom Distress Module questionnaire</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>The Symptom Distress Module is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. This included sub-scales change in treatment satisfaction, individual satisfaction with treatment change. Treatment satisfaction score summed all items to produce scores ranging from +30 to -30, higher the score, greater the improvement in satisfaction with treatment, lower score greater is the deterioration in satisfaction. Individual item scores which included All rate score ranging from +3 (much more satisfied, much more convenient, much more flexible) to -3 (much less satisfied, much less convenient, much less flexible). General satisfaction and life style scores all items summed to produce score range +15 to -15, where higher the score greater the improvement in satisfaction, lower score greater is the deterioration in satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for switching to/prescription of DTG plus 3TC</measure>
    <time_frame>Day 1</time_frame>
    <description>The reasons for switching to/prescription of DTG plus 3TC as selected by the investigator from a pre-specified list will be summarized</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Treatment naïve subjects with HIV infection</arm_group_label>
    <description>Treatment naïve HIV-1 positive subjects for whom DTG+3TC is indicated according to local label will be included</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pre-treated subjects with HIV infection</arm_group_label>
    <description>Pre-treated HIV-1 positive subjects for whom DTG+3TC is indicated according to local label will be included.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HIV Symptom Distress Module Questionnaire</intervention_name>
    <description>The Symptom Distress Module is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.</description>
    <arm_group_label>Pre-treated subjects with HIV infection</arm_group_label>
    <arm_group_label>Treatment naïve subjects with HIV infection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HIV treatment satisfaction questionnaire</intervention_name>
    <description>The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility.</description>
    <arm_group_label>Pre-treated subjects with HIV infection</arm_group_label>
    <arm_group_label>Treatment naïve subjects with HIV infection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 300 treatment naïve and pre-treated HIV-1 positive subjects from Germany will&#xD;
        be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with &gt;= 18 years of age.&#xD;
&#xD;
          -  Subjects with documented HIV-1 infection.&#xD;
&#xD;
          -  Prescription of DTG + 3TC was issued independently from entering this study.&#xD;
&#xD;
          -  Subjects with the ability to understand informed consent form and other relevant&#xD;
             regulatory documents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication according to Tivicay or Lamivudine summaries of product&#xD;
             characteristics (SmPCs).&#xD;
&#xD;
          -  Subjects with VL &gt; 500 c/mL.&#xD;
&#xD;
          -  Any antiretroviral therapy for the treatment of HIV-1 in addition to DTG and 3TC or&#xD;
             the DTG/3TC fixed dose combination (FDC).&#xD;
&#xD;
          -  Subjects with hepatitis B virus (HBV)- coinfection.&#xD;
&#xD;
          -  Subjects with current participation in the ongoing non-interventional study TRIUMPH&#xD;
             (study number: 202033, NCT number: NCT02342769) or in any interventional clinical&#xD;
             trial irrespective of indication.&#xD;
&#xD;
          -  Subjects who had previously participated in clinical trials assessing DTG+ 3TC.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>ViiV Healthcare</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>US GSK Clinical Trials Call Center</last_name>
    <phone>877-379-3718</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>EU GSK Clinical Trials Call Center</last_name>
    <phone>+44 (0) 20 89904466</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Wuerttemberg</state>
        <zip>68161</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Juergen Brust</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Muenchen</city>
        <state>Bayern</state>
        <zip>80331</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ramona Pauli</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Muenchen</city>
        <state>Bayern</state>
        <zip>80335</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Sebastian Noe</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Muenchen</city>
        <state>Bayern</state>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Nils Postel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osnabrueck</city>
        <state>Niedersachsen</state>
        <zip>49090</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aachen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>52062</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bochum</city>
        <state>Nordrhein-Westfalen</state>
        <zip>44787</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Koeln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50674</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Stefan Scholten</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10243</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10629</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Thomas Wuensche</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10777</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>12163</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>14057</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ulrich Bohr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>14059</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20146</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Michael Sabranski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Olaf Degen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Koeln</city>
        <zip>50668</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Christoph Wyen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Weimar</city>
        <zip>99427</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Thomas Seidel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>October 11, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dolutegravir</keyword>
  <keyword>Two-drug regimen</keyword>
  <keyword>Human Immunodeficiency Virus</keyword>
  <keyword>HIV Symptom Distress Module</keyword>
  <keyword>Lamivudine</keyword>
  <keyword>HIV treatment satisfaction questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>http://clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <!-- 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/NCT03754803
org study id: 208983
nct id: NCT03754803
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated device: No
This is a prospective, non-interventional, multi-center study, in subjects with clinical
      indication of Human Immunodeficiency Virus (HIV)-1 infection. The aim of the study is to
      generate the real world evidence for the use of DTG+3TC in routine clinical care in Germany
      to supplement data obtained from controlled clinical trials. Approximately, 300 treatment
      naïve and pre-treated HIV-1 positive subjects will be enrolled in the study. The observation
      period for the study will be 3 years. Data will be collected from routine clinical care via
      electronic data capture (EDC) system.
observational model: Cohort
time perspective: Prospective
measure: Percentage of subjects with sustained virologic suppression, with Viral load (VL) < 50 Copies per Milliliter (c/mL)
time frame: Up to 36 months
description: Percentage of subjects with sustained virologic suppression, defined as VL <50 c/mL or if between 50-200 c/mL with a subsequent next available measurement <50 c/mL (within 120 days) will be evaluated.
measure: Percentage of pre-treated subjects with low level viremia
time frame: Up to 36 months
description: Percentage of subjects with low level viremia, defined as a VL measurement between >50 to <200 c/mL for pre-treated subjects will be evaluated.
measure: Percentage of naïve subjects with low level viremia after initial suppression
time frame: Up to 36 months
description: Percentage of subjects with low level viremia, defined as a VL measurement between >50 to <200 c/mL after initial suppression of <50 c/mL for naïve subjects will be evaluated.
measure: Percentage of virologic non-responders for naïve subjects
time frame: Up to 36 months
description: Percentage of virologic non-responders, defined as two consecutive measurements >=200 c/mL after at least 24 weeks of treatment in naïve subjects will be evaluated.
measure: Percentage of naïve subjects with virologic rebound
time frame: Up to 36 months
description: Percentage of naïve subjects with virologic rebound, defined as two consecutive VL measurements >=200 c/mL after suppression (one VL <50 c/mL) will be evaluated.
measure: Percentage of subjects with VL < 50 c/mL
time frame: Up to 36 months
description: Percentage of subjects with VL <50 c/mL will be evaluated.
measure: Percentage of subjects with two consecutive VL measurements of >=200 c/mL
time frame: Up to 36 months
description: Percentage of subjects with two consecutive VL measurements of >=200 c/mL will be evaluated.
measure: Percentage of subjects with treatment switch
time frame: Up to 36 months
description: Percentage of subjects with treatment switch due to virologic failure (VF) or due to intolerability determined at the discretion of the physician will be evaluated.
measure: Percentage of subjects with VL > 50 c/mL with emergent resistance mutations
time frame: Up to 36 months
description: Percentage of subjects with VL >50 c/mL with emergent resistance mutations will be summarized. Resistance analysis will be performed at the physician's discretion.
measure: Number of monitoring measures
time frame: Up to 36 months
description: Number of monitoring measures (normalized to subject years) will be summarized.
measure: Number and frequency of serious adverse events (SAE)
time frame: Up to 36 months
description: An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
measure: Number and frequency of adverse drug reactions (ADRs)
time frame: Up to 36 months
description: An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, that is the relationship cannot be ruled out.
measure: Adherence to therapy
time frame: Up to 36 months
description: Adherence to therapy will be determined from the number of monthly doses missed.
measure: Change from Baseline for lipid laboratory parameter: lactate dehydrogenase (LDH)
time frame: Baseline and up to 36 months
description: Lipid laboratory parameter LDH data will be evaluated at indicated time points.
measure: Change from Baseline for lipid laboratory parameters: cholesterol and triglycerides
time frame: Baseline and up to 36 months
description: Lipid laboratory parameters cholesterol and triglycerides data will be evaluated at indicated time points.
measure: Change in treatment satisfaction based on HIV Treatment Satisfaction questionnaire (HIV TSQ)
time frame: Up to 36 months
description: The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility. In treatment satisfaction score will range from 0-60, higher the score, greater the satisfaction with treatment. Individual item scores which included All rate score ranging from 0 (very dissatisfied, inconvenient, inflexible) to 6 (very satisfied, convenient, flexible), in case of general satisfaction , there will be 10 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale. For lifestyle scale with 8 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale.
measure: Change in Symptom Distress based on HIV Symptom Distress Module questionnaire
time frame: Up to 36 months
description: The Symptom Distress Module is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. This included sub-scales change in treatment satisfaction, individual satisfaction with treatment change. Treatment satisfaction score summed all items to produce scores ranging from +30 to -30, higher the score, greater the improvement in satisfaction with treatment, lower score greater is the deterioration in satisfaction. Individual item scores which included All rate score ranging from +3 (much more satisfied, much more convenient, much more flexible) to -3 (much less satisfied, much less convenient, much less flexible). General satisfaction and life style scores all items summed to produce score range +15 to -15, where higher the score greater the improvement in satisfaction, lower score greater is the deterioration in satisfaction.
measure: Reasons for switching to/prescription of DTG plus 3TC
time frame: Day 1
description: The reasons for switching to/prescription of DTG plus 3TC as selected by the investigator from a pre-specified list will be summarized
arm group label: Treatment naïve subjects with HIV infection
description: Treatment naïve HIV-1 positive subjects for whom DTG+3TC is indicated according to local label will be included
arm group label: Pre-treated subjects with HIV infection
description: Pre-treated HIV-1 positive subjects for whom DTG+3TC is indicated according to local label will be included.
intervention type: Other
intervention name: HIV Symptom Distress Module Questionnaire
description: The Symptom Distress Module is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.
arm group label: Pre-treated subjects with HIV infection
arm group label: Treatment naïve subjects with HIV infection
intervention type: Other
intervention name: HIV treatment satisfaction questionnaire
description: The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility.
arm group label: Pre-treated subjects with HIV infection
arm group label: Treatment naïve subjects with HIV infection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: GSK Clinical Trials
role: Study Director
affiliation: ViiV Healthcare
last name: US GSK Clinical Trials Call Center
phone: 877-379-3718
email: GSKClinicalSupportHD@gsk.com
last name: EU GSK Clinical Trials Call Center
phone: +44 (0) 20 89904466
email: GSKClinicalSupportHD@gsk.com
facility: 
status: Recruiting
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country: Germany
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.
ipd url: http://clinicalstudydatarequest.com