<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/NCT04416906</url>
  </required_header>
  <id_info>
    <org_study_id>Biktarvy Test&amp;Treat</org_study_id>
    <secondary_id>2019-004837-17</secondary_id>
    <nct_id>NCT04416906</nct_id>
  </id_info>
  <brief_title>A Test and Treat Strategy in New HIV Diagnosis.</brief_title>
  <acronym>Test&amp;Treat</acronym>
  <official_title>A Test and Treat Strategy in Barcelona: A Prospective Study in New HIV Diagnosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Judit Pich Martínez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion Clinic per a la Recerca Biomédica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single arm, single-centre prospective study to evaluate the&#xD;
      feasibility, efficacy and safety of a once daily fixed dose combination regimen, Biktarvy, as&#xD;
      a rapid treatment strategy in newly HIV diagnosed patients that come for the first time to&#xD;
      the Hospital Clínic HIV Unit Patients with confirmed HIV-1 diagnosis who wish to start ARV&#xD;
      treatment immediately will receive bictegravir 50 mg + emtricitabine 200 mg + tenofovir&#xD;
      alafenamide 25 mg within the first week since the HIV-1 confirmation during 48 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Actual">May 11, 2023</completion_date>
  <primary_completion_date type="Actual">May 11, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is an open-label, single arm, single-centre prospective study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) at week 4</measure>
    <time_frame>week 4</time_frame>
    <description>Patients will be considered non-eligible if they meet one or more of the following creiteria at week 4:&#xD;
Presence of HLA-B* 5701 or lack of HLA test&#xD;
Presence of HIV genotypic resistance mutations to at least one class of ARV drug that decrease efficacy of antiretroviral treatment&#xD;
CD4 count &lt; 200 cells/mm3&#xD;
Viral load &gt; 100.000 copies/mL&#xD;
Comorbidities such as: Osteopenia measured by DXA (T score less than 1), medical history of cardiovascular risk measured by Framingham risk score &gt; 10% at 10 years, Kidney function (eGFR &lt;50mL/min),&#xD;
Concomitant medication that can cause potential interactions with ARV (evaluating the risk of drug-drug interactions for drugs no totally safe (green colour) using the Liverpool website for DDI)&#xD;
Hepatitis B (HBV) coinfection or lack of serology</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit.</measure>
    <time_frame>week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days since first HIV test was performed until Biktarvy is initiated.</measure>
    <time_frame>week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated.</measure>
    <time_frame>week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with plasma viral load (VIH-1 RNA) &lt; 50 copies/mL at 4, 12, 24 and 48 weeks.</measure>
    <time_frame>week 4, week 12, week 24 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from week 0 in CD4 and CD8 count and CD4/CD8 ratio at 24 and 48 weeks.</measure>
    <time_frame>week 24 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in systemic inflammatory and coagulation response evaluated by measurement of soluble markers including, but not limited to IL-6, ultrasensitive PCR, Dimer-D at 48 weeks.</measure>
    <time_frame>week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in senescence response evaluated by measurement of soluble markers of senescence including, but not limited to, bcl-2 apoptosis marker at 24 and 48 weeks.</measure>
    <time_frame>week 24 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks.</measure>
    <time_frame>week 24 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks.</measure>
    <time_frame>week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with treatment-related adverse events during the study period.</measure>
    <time_frame>week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who discontinue study treatment due to adverse events at 48 weeks.</measure>
    <time_frame>week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period.</measure>
    <time_frame>week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient perception of rapid start of Biktarvy therapy using a specific questionnaire (CESTA) at 48 weeks.</measure>
    <time_frame>week 48</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>HIV-1-infection</condition>
  <arm_group>
    <arm_group_label>Biktarvy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Biktarvy</intervention_name>
    <description>Once daily fixed dose combination regimen of Biktarvy will be evaluated as a rapid treatment strategy in newly HIV diagnosed patients HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit</description>
    <arm_group_label>Biktarvy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years old.&#xD;
&#xD;
          2. Having confirmed HIV-1 positive test.&#xD;
&#xD;
          3. Patients not previously treated with antiretroviral treatment (post-exposure&#xD;
             prophylaxis will be allowed if not done in the previous 6 months).&#xD;
&#xD;
          4. Clinically stable patients, in the opinion of the investigator, at the time of&#xD;
             inclusion.&#xD;
&#xD;
          5. Women of child-bearing potential* must have a negative pregnancy test in urine before&#xD;
             the inclusion in the study and agree to use highly effective contraceptive methods&#xD;
             during the study. Highly effective contraceptive methods will include: hormonal&#xD;
             contraceptive methods intrauterine device, bilateral tubal occlusion, vasectomized&#xD;
             partner or sexual abstinence.&#xD;
&#xD;
          6. Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or breastfeeding women at the time of the study inclusion or anticipating&#xD;
             pregnancy during the follow-up period.&#xD;
&#xD;
          2. Suspicion of an active opportunistic infection that defers initiating antiretroviral&#xD;
             treatment &gt; 7 days since HIV confirmation.&#xD;
&#xD;
          3. Known hypersensitivity or intolerance of any of the components of Biktarvy®.&#xD;
&#xD;
          4. Patients on treatment with any prohibited medication (see section 5.2: Concomitant,&#xD;
             nonpermitted and permitted medication).&#xD;
&#xD;
          5. Any condition which, in the opinion of the principal investigator, may interfere with&#xD;
             adequate understanding, cooperation or compliance with the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Torres Berta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion Clinic per a la Recerca Biomédica</investigator_affiliation>
    <investigator_full_name>Judit Pich Martínez</investigator_full_name>
    <investigator_title>Clinical Research Manager</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>A plan description will be provided once it is decided</ipd_description>
  </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/NCT04416906
org study id: Biktarvy Test&Treat
secondary id: 2019-004837-17
nct id: NCT04416906
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an open-label, single arm, single-centre prospective study to evaluate the
      feasibility, efficacy and safety of a once daily fixed dose combination regimen, Biktarvy, as
      a rapid treatment strategy in newly HIV diagnosed patients that come for the first time to
      the Hospital Clínic HIV Unit Patients with confirmed HIV-1 diagnosis who wish to start ARV
      treatment immediately will receive bictegravir 50 mg + emtricitabine 200 mg + tenofovir
      alafenamide 25 mg within the first week since the HIV-1 confirmation during 48 weeks.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: This is an open-label, single arm, single-centre prospective study
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) at week 4
time frame: week 4
description: Patients will be considered non-eligible if they meet one or more of the following creiteria at week 4:
Presence of HLA-B* 5701 or lack of HLA test
Presence of HIV genotypic resistance mutations to at least one class of ARV drug that decrease efficacy of antiretroviral treatment
CD4 count < 200 cells/mm3
Viral load > 100.000 copies/mL
Comorbidities such as: Osteopenia measured by DXA (T score less than 1), medical history of cardiovascular risk measured by Framingham risk score > 10% at 10 years, Kidney function (eGFR <50mL/min),
Concomitant medication that can cause potential interactions with ARV (evaluating the risk of drug-drug interactions for drugs no totally safe (green colour) using the Liverpool website for DDI)
Hepatitis B (HBV) coinfection or lack of serology
measure: Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit.
time frame: week 4
measure: Days since first HIV test was performed until Biktarvy is initiated.
time frame: week 4
measure: Days since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated.
time frame: week 4
measure: Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks.
time frame: week 4, week 12, week 24 and week 48
measure: Changes from week 0 in CD4 and CD8 count and CD4/CD8 ratio at 24 and 48 weeks.
time frame: week 24 and week 48
measure: Changes from baseline in systemic inflammatory and coagulation response evaluated by measurement of soluble markers including, but not limited to IL-6, ultrasensitive PCR, Dimer-D at 48 weeks.
time frame: week 48
measure: Changes from baseline in senescence response evaluated by measurement of soluble markers of senescence including, but not limited to, bcl-2 apoptosis marker at 24 and 48 weeks.
time frame: week 24 and week 48
measure: Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks.
time frame: week 24 and week 48
measure: Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks.
time frame: week 48
measure: Proportion of patients with treatment-related adverse events during the study period.
time frame: week 48
measure: Proportion of patients who discontinue study treatment due to adverse events at 48 weeks.
time frame: week 48
measure: Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period.
time frame: week 48
measure: Patient perception of rapid start of Biktarvy therapy using a specific questionnaire (CESTA) at 48 weeks.
time frame: week 48
arm group label: Biktarvy
arm group type: Experimental
description: This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide.
intervention type: Drug
intervention name: Biktarvy
description: Once daily fixed dose combination regimen of Biktarvy will be evaluated as a rapid treatment strategy in newly HIV diagnosed patients HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit
arm group label: Biktarvy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Torres Berta, MD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Fundacion Clinic per a la Recerca Biomédica
investigator full name: Judit Pich Martínez
investigator title: Clinical Research Manager
sharing ipd: Undecided
ipd description: A plan description will be provided once it is decided