<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/NCT04483674</url>
  </required_header>
  <id_info>
    <org_study_id>2020-000601-89</org_study_id>
    <nct_id>NCT04483674</nct_id>
  </id_info>
  <brief_title>Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection</brief_title>
  <acronym>BIC-PHI</acronym>
  <official_title>Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anna Cruceta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with&#xD;
      less of 100 days post HIV infection&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After providing informed consent, patients will undergo to a screening visit. If they meet&#xD;
      the inclusion criteria and none of the exclusion will be included in this trial. Patients&#xD;
      will take one tablet of Biktarvy at day for 48 weeks. Then the results will be compared with&#xD;
      a cohort of 66 patients treated with 2 nucleoside analogues and one integrase chain transfer&#xD;
      inhibitor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 4, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Portion of patients with a VL (viral load)&lt; 50 Copies at week 48</measure>
    <time_frame>48 weeks</time_frame>
    <description>Portion of patients with rapid ART (Antiretroviral therapy) initiation who reached a VL&lt; 50 copies at 48 week in the intention to treat population determined by PCR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Viral Load at 4,8,12,24 y 48 weeks</measure>
    <time_frame>weeks 4,8,12,24,48</time_frame>
    <description>Determination by PCR (Polymerase Chain Reaction) of viral load at differents weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Portion of patients with &gt; 900 cells CD4+</measure>
    <time_frame>weeks 24 and 48</time_frame>
    <description>Proportion of patients with &gt;900 cells CD4+</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days elapsed between diagnosis and bictegravir/FTC/TAF initiation</measure>
    <time_frame>week 48</time_frame>
    <description>Days elapsed between diagnosis and bictegravir/FTC/TAF initiation, day elapsed between first clinical visit and Bictegravir/FTC/TAF initiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL&lt;50 copies at 48 weeks in the intention-to-treat (ITT) population</measure>
    <time_frame>week 48</time_frame>
    <description>Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL&lt;50 copies at 48 weeks in the intention-to-treat (ITT) population in comparison with other InSTI-, based ART regimens</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE (adverse event) leading to discontinuation rate</measure>
    <time_frame>week 48</time_frame>
    <description>AE leading to discontinuation rate in comparison with other InSTI- based ATR regimens</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4, CD4/CD8 ratio</measure>
    <time_frame>weeks 4,8,12,24,48</time_frame>
    <description>CD4, CD4/CD8 ratio at weeks 4,8,12,24 and 48</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE rate</measure>
    <time_frame>week 48</time_frame>
    <description>AE rate (overall and AE leading to discontinuation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of required regimen changes</measure>
    <time_frame>week 48</time_frame>
    <description>Number of required regimen changes stratified by: adverse events/toxicity, virological failure, simplification, transmitted drug resistance (including polymorphisms for InSTIs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life and satisfaction: questionnaire</measure>
    <time_frame>day 0, week 4 and 48</time_frame>
    <description>Quality of life and satisfaction evaluated through a CESTA questionnaire (Spanish Questionnaire of Satisfaction whit Antiretroviral Treatment) at 4 and 48 weeks (or at the end of study in case of early termination) of the study period, and Pittsburgh Sleep Quality Index (PSQI) at day 0, 4 week and 48 weeks (or at the end of study in case of early termination) of the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral reservoir, inflammatory and immunological markers and fecal microbiome composition</measure>
    <time_frame>weeks 0,48</time_frame>
    <description>Viral reservoir, inflammatory and immunological markers and fecal microbiome composition</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>HIV Primary Infection</condition>
  <arm_group>
    <arm_group_label>Biktarvy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide</intervention_name>
    <description>Patients will be administered one pill of 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide daily for 48 weeks with regular check-ups at weeks 4,8,12,24 and 48 including:&#xD;
complete physical examination&#xD;
register concomitant medication&#xD;
blood test&#xD;
concomitant medications&#xD;
assessment od adverse events&#xD;
assessement of compliance&#xD;
PSQI and CESTA questionnaire (week 4 and 48)&#xD;
Recommendation in contraception methods&#xD;
Stool sample and pregnancy test urine (week 0 and 48)&#xD;
The total of blood required for each visit is 30ml except the visit of week 48 (90ml) The total of urine required is 6 mL</description>
    <arm_group_label>Biktarvy</arm_group_label>
    <other_name>Biktarvy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients aged 18-65 years&#xD;
&#xD;
          -  ART naïve&#xD;
&#xD;
          -  HIV infection of less than 100 days post-infection (documented 3 month previous&#xD;
             negative serology or incomplete WB test with negative p31 band)&#xD;
&#xD;
          -  Women of child-bearing potential must have a negative pregnancy test in serum before&#xD;
             the inclusion in the study and agree to use highly effective contraceptive methods,&#xD;
             including intrauterine device, bilateral tubal occlusion or a vasectomized partner.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to any drug included in Bictegravir/FTC/TAF regimen&#xD;
&#xD;
          -  AST &gt;5 times UNL&#xD;
&#xD;
          -  Creatinine Clearance &lt;30 mL/min/1.73m2&#xD;
&#xD;
          -  Any end-stage organ disease&#xD;
&#xD;
          -  Acute or chronic HCV co-infection&#xD;
&#xD;
          -  Use of PrEP with Truvada® until 4 weeks before the onset of symptoms of PHI (risk of&#xD;
             acquired-drug resistance to FCT or TDF).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anna Cruceta, MD</last_name>
    <phone>9322754000</phone>
    <phone_ext>4380</phone_ext>
    <email>acruceta@clinic.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jose María Miró, MD</last_name>
    <email>jmmiro@clinic.cat</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Clinic</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jose M Miró, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Juan Ambrosioni, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Josep Mallolas, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sonsoles Sanchez</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Montserrat Plana</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cristina Rovira</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carmen Hurtado</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>José Alcamí</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 16, 2021</last_update_submitted>
  <last_update_submitted_qc>July 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2021</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>Anna Cruceta</investigator_full_name>
    <investigator_title>Project Manager</investigator_title>
  </responsible_party>
  <keyword>Human Immunodeficiency Virus</keyword>
  <keyword>HIV Primary Infection</keyword>
  <keyword>Biktarvy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Emtricitabine</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/NCT04483674
org study id: 2020-000601-89
nct id: NCT04483674
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with
      less of 100 days post HIV infection
After providing informed consent, patients will undergo to a screening visit. If they meet
      the inclusion criteria and none of the exclusion will be included in this trial. Patients
      will take one tablet of Biktarvy at day for 48 weeks. Then the results will be compared with
      a cohort of 66 patients treated with 2 nucleoside analogues and one integrase chain transfer
      inhibitor.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Portion of patients with a VL (viral load)< 50 Copies at week 48
time frame: 48 weeks
description: Portion of patients with rapid ART (Antiretroviral therapy) initiation who reached a VL< 50 copies at 48 week in the intention to treat population determined by PCR
measure: Viral Load at 4,8,12,24 y 48 weeks
time frame: weeks 4,8,12,24,48
description: Determination by PCR (Polymerase Chain Reaction) of viral load at differents weeks of treatment
measure: Portion of patients with > 900 cells CD4+
time frame: weeks 24 and 48
description: Proportion of patients with >900 cells CD4+
measure: Days elapsed between diagnosis and bictegravir/FTC/TAF initiation
time frame: week 48
description: Days elapsed between diagnosis and bictegravir/FTC/TAF initiation, day elapsed between first clinical visit and Bictegravir/FTC/TAF initiation
measure: Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population
time frame: week 48
description: Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population in comparison with other InSTI-, based ART regimens
measure: AE (adverse event) leading to discontinuation rate
time frame: week 48
description: AE leading to discontinuation rate in comparison with other InSTI- based ATR regimens
measure: CD4, CD4/CD8 ratio
time frame: weeks 4,8,12,24,48
description: CD4, CD4/CD8 ratio at weeks 4,8,12,24 and 48
measure: AE rate
time frame: week 48
description: AE rate (overall and AE leading to discontinuation)
measure: Number of required regimen changes
time frame: week 48
description: Number of required regimen changes stratified by: adverse events/toxicity, virological failure, simplification, transmitted drug resistance (including polymorphisms for InSTIs).
measure: Quality of life and satisfaction: questionnaire
time frame: day 0, week 4 and 48
description: Quality of life and satisfaction evaluated through a CESTA questionnaire (Spanish Questionnaire of Satisfaction whit Antiretroviral Treatment) at 4 and 48 weeks (or at the end of study in case of early termination) of the study period, and Pittsburgh Sleep Quality Index (PSQI) at day 0, 4 week and 48 weeks (or at the end of study in case of early termination) of the study period
measure: Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
time frame: weeks 0,48
description: Viral reservoir, inflammatory and immunological markers and fecal microbiome composition
arm group label: Biktarvy
arm group type: Experimental
description: Patients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks
intervention type: Drug
intervention name: 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide
description: Patients will be administered one pill of 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide daily for 48 weeks with regular check-ups at weeks 4,8,12,24 and 48 including:
complete physical examination
register concomitant medication
blood test
concomitant medications
assessment od adverse events
assessement of compliance
PSQI and CESTA questionnaire (week 4 and 48)
Recommendation in contraception methods
Stool sample and pregnancy test urine (week 0 and 48)
The total of blood required for each visit is 30ml except the visit of week 48 (90ml) The total of urine required is 6 mL
arm group label: Biktarvy
other name: Biktarvy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Anna Cruceta, MD
phone: 9322754000
phone ext: 4380
email: acruceta@clinic.cat
last name: Jose María Miró, MD
email: jmmiro@clinic.cat
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Fundacion Clinic per a la Recerca Biomédica
investigator full name: Anna Cruceta
investigator title: Project Manager
mesh term: Infections
mesh term: Communicable Diseases
mesh term: HIV Infections
mesh term: Tenofovir
mesh term: Emtricitabine