<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/NCT03042390</url>
  </required_header>
  <id_info>
    <org_study_id>GESIDA 9316</org_study_id>
    <nct_id>NCT03042390</nct_id>
  </id_info>
  <brief_title>Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice</brief_title>
  <acronym>CoDAR</acronym>
  <official_title>Multicenter Retrospective Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion SEIMC-GESIDA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen-Cilag, S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion SEIMC-GESIDA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective observational study of patients who have taken a regimen containing&#xD;
      DRV / c at least 24 weeks prior to study initiation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include 750 patients and will record data at 24 weeks. The study will also&#xD;
      record data at 48 weeks for those patients whom these data are available&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 23, 2016</start_date>
  <completion_date type="Actual">May 9, 2017</completion_date>
  <primary_completion_date type="Actual">May 9, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Virological effectiveness data: Percentage of patients with undetectable viral load</measure>
    <time_frame>24 weeks</time_frame>
    <description>Virological effectiveness data at 24 weeks: Percentage of patients with undetectable viral load, defined as HIV RNA &lt;50 copies / m.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change in the number of CD4 + T cells at 24 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Virological effectiveness data: time to loss of virological efficacy.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Defined virological failure as two consecutive levels of HIV RNA &gt; 50 copies / mL or single HIV RNA ≥ 500 copies / mL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Virological effectiveness data: Percentage of patients with undetectable viral load, defined as HIV RNA levels ≤ 50 copies / mL or limit of detection of the center, at 48 weeks</measure>
    <time_frame>48 weeks</time_frame>
    <description>Virological effectiveness data at 48 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks</measure>
    <time_frame>48 weeks</time_frame>
    <description>Virological effectiveness data at 48 weeks: change in the number of CD4 + T cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI).</measure>
    <time_frame>Basal and 24 weeks/48 weeks</time_frame>
    <description>Creatinine (mg/dl), eFG (CKD-EPI) (ml/min/1,73 m2),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG.</measure>
    <time_frame>basal and 24 weeks/48 weeks</time_frame>
    <description>Units: mg/dl or mmol/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT</measure>
    <time_frame>basal and 24 weeks/48 weeks</time_frame>
    <description>GOT, GPT, FA, GGT in units: UI/l or μKat/l or mU/ml. BrT in units: mg/dl or micromol/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability data:Rate of patients discontinuing treatment for toxicity.</measure>
    <time_frame>24 weeks/48 weeks</time_frame>
    <description>Toxicity to the treatment or virological failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks</measure>
    <time_frame>24 weeks/48 weeks</time_frame>
    <description>Virological failure defined as two consecutive levels of HIV RNA &gt; 50 copies / mL or single HIV RNA ≥ 500 copies / mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients who develop any adverse effects:frequency of adverse events,frequency of serious adverse events, frequency of adverse events leading to discontinuation of treatment, number of deaths and frequency of laboratory abnormalities.</measure>
    <time_frame>24 weeks/48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Representative subgroups of patients according to the treatment that patient is taking: Percentage of patients with different Darunavir/cobicistat based regimens (Monotherapy, Bitherapy, triple Therapy, others)</measure>
    <time_frame>24 weeks / 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen</measure>
    <time_frame>24 weeks / 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for the change prior the initiation:Percentage of patients with each main reason to change to a DRV/c based regimen (first regimen, simplification, intolerance or toxicity, prior adherence problems, prior interactions, prior failure, others)</measure>
    <time_frame>24 weeks / 48 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">762</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>DArunavir/cobicistat</arm_group_label>
    <description>Patients starting treatment with a regimen containing Darunavir / cobicistat for at least 24 weeks</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        HIV patients that initiated treatment with a régimen containing DRV/c at least 24 weeks&#xD;
        prior initiation of study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with HIV infection&#xD;
&#xD;
          -  Inform consent document.&#xD;
&#xD;
          -  To have initiated therapy containing DRV / c and have a follow-up of at least 24&#xD;
             Weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not having evaluable clinical data of the patient&#xD;
&#xD;
          -  Patients not routinely followed in the center&#xD;
&#xD;
          -  Patient less than 18 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Costa del Sol</name>
      <address>
        <city>Malaga</city>
        <state>Marbella</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Guadalajara</name>
      <address>
        <city>Guadalajara</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infanta Leonor</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Princesa</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Príncipe de Asturias</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta de Hierro</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Victoria</name>
      <address>
        <city>Malaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Son Llatzer</name>
      <address>
        <city>Palma de Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Valme</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Toledo</name>
      <address>
        <city>Toledo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico de Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalaria Alvaron Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 3, 2020</last_update_submitted>
  <last_update_submitted_qc>February 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</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>
  <!-- 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/NCT03042390
org study id: GESIDA 9316
nct id: NCT03042390
lead sponsor: 
collaborator: 
has dmc: No
This is a retrospective observational study of patients who have taken a regimen containing
      DRV / c at least 24 weeks prior to study initiation
The study will include 750 patients and will record data at 24 weeks. The study will also
      record data at 48 weeks for those patients whom these data are available
observational model: Case-Control
time perspective: Retrospective
measure: Virological effectiveness data: Percentage of patients with undetectable viral load
time frame: 24 weeks
description: Virological effectiveness data at 24 weeks: Percentage of patients with undetectable viral load, defined as HIV RNA <50 copies / m.
measure: Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks
time frame: 24 weeks
description: Change in the number of CD4 + T cells at 24 weeks
measure: Virological effectiveness data: time to loss of virological efficacy.
time frame: 24 weeks
description: Defined virological failure as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL
measure: Virological effectiveness data: Percentage of patients with undetectable viral load, defined as HIV RNA levels ≤ 50 copies / mL or limit of detection of the center, at 48 weeks
time frame: 48 weeks
description: Virological effectiveness data at 48 weeks
measure: Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks
time frame: 48 weeks
description: Virological effectiveness data at 48 weeks: change in the number of CD4 + T cells
measure: Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI).
time frame: Basal and 24 weeks/48 weeks
description: Creatinine (mg/dl), eFG (CKD-EPI) (ml/min/1,73 m2),
measure: Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG.
time frame: basal and 24 weeks/48 weeks
description: Units: mg/dl or mmol/l
measure: Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT
time frame: basal and 24 weeks/48 weeks
description: GOT, GPT, FA, GGT in units: UI/l or μKat/l or mU/ml. BrT in units: mg/dl or micromol/l
measure: Tolerability data:Rate of patients discontinuing treatment for toxicity.
time frame: 24 weeks/48 weeks
description: Toxicity to the treatment or virological failure
measure: Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks
time frame: 24 weeks/48 weeks
description: Virological failure defined as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL
measure: Rate of patients who develop any adverse effects:frequency of adverse events,frequency of serious adverse events, frequency of adverse events leading to discontinuation of treatment, number of deaths and frequency of laboratory abnormalities.
time frame: 24 weeks/48 weeks
measure: Representative subgroups of patients according to the treatment that patient is taking: Percentage of patients with different Darunavir/cobicistat based regimens (Monotherapy, Bitherapy, triple Therapy, others)
time frame: 24 weeks / 48 weeks
measure: Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen
time frame: 24 weeks / 48 weeks
measure: Reason for the change prior the initiation:Percentage of patients with each main reason to change to a DRV/c based regimen (first regimen, simplification, intolerance or toxicity, prior adherence problems, prior interactions, prior failure, others)
time frame: 24 weeks / 48 weeks
arm group label: DArunavir/cobicistat
description: Patients starting treatment with a regimen containing Darunavir / cobicistat for at least 24 weeks
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: Spain
responsible party type: Sponsor
mesh term: HIV Infections