<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/NCT03797014</url>
  </required_header>
  <id_info>
    <org_study_id>HP00083844</org_study_id>
    <nct_id>NCT03797014</nct_id>
  </id_info>
  <brief_title>B/F/TAF Switch Study for HIV-HBV Coinfection</brief_title>
  <acronym>BEST-HBV</acronym>
  <official_title>Efficacy, Safety, and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-HBV Coinfection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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 primary objective of this study is to evaluate the efficacy and safety of fixed dose&#xD;
      combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults&#xD;
      coinfected with both HIV-1 and hepatitis B. As this is a switch study, all eligible subjects&#xD;
      enrolled will be switched from their current antiretroviral regimen to B/F/TAF will be&#xD;
      followed on treatment for 48 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2019</start_date>
  <completion_date type="Actual">May 5, 2023</completion_date>
  <primary_completion_date type="Actual">November 22, 2022</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>This is an open-label phase 4 switch study to evaluate the efficacy, safety, and tolerability of FDC B/F/TAF in adults with HIV-1 and HBV coinfection.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This is an open label study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>HIV-1 RNA at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Proportion of participants with HIV-1 RNA &lt;50 copies/mL at Week 24 by US FDA Snapshot Algorithm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HBV DNA at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Proportion of participants with plasma HBV DNA &lt;29 IU/mL at Week 24 as defined by Missing=Failure Approach</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV-1 RNA at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Proportion of participants with HIV-1 RNA &lt;50 copies/mL at Week 48 by US FDA Snapshot Algorithm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HBV DNA at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Proportion of participants with plasma HBV DNA &lt;29 IU/mL at Week 48 as defined by Missing=Failure Approach</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4 Cell Count Change at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from baseline in CD4 cell count at Week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4 Cell Count Change at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from baseline in CD4 cell count at Week 48</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALT Normalization at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Proportion of participants with normal ALT at Week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALT Normalization at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Proportion of participants with normal ALT at Week 48</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HBeAg Loss at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HBsAg Loss at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>HIV-1-infection</condition>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>B/F/TAF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment group (1-arm study)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>B/F/TAF</intervention_name>
    <description>Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
    <arm_group_label>B/F/TAF</arm_group_label>
    <other_name>Bictegravir/emtricitabine/tenofovir alafenamide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years or older at enrollment.&#xD;
&#xD;
          2. Documented HIV-1 infection and currently on a stable regimen for at least 3 months if&#xD;
             on an INSTI-based regimen (6 months if on a non-INSTI-based regimen) preceding the&#xD;
             screening visit with documented plasma HIV-1 RNA ≤ 50 copies/mL for at least 3 months&#xD;
             preceding the screening visit.&#xD;
&#xD;
          3. No known history of resistance to tenofovir alafenamide (TAF), emtricitabine (FTC), or&#xD;
             Bictegravir (BIC).&#xD;
&#xD;
          4. Documented chronic hepatitis B infection, based on any of the following: a. Positive&#xD;
             HBsAg result or nucleic acid test for HBV DNA (including qualitative, quantitative,&#xD;
             and genotype testing) or positive HBeAg on two occasions at least 6 months apart (any&#xD;
             combination of these tests performed 6 months apart is acceptable); or b. Negative&#xD;
             immunoglobulin M (IgM) antibodies to HBV core antigen (anti-HBc IgM) AND a positive&#xD;
             results on one of the following tests: HBsAg, HBeAg, or nucleic acid test for HBV DNA&#xD;
             (including qualitative, quantitative, and genotype testing) prior to or at screening.&#xD;
&#xD;
          5. No current or prior regimen containing three active anti-HBV agents (i.e. cannot be on&#xD;
             tenofovir alafenamide (TDF)/emtricitabine (FTC)/entecavir or TDF/lamivudine&#xD;
             (3TC)/entecavir).&#xD;
&#xD;
          6. Must have a primary care provider(s) for medical management.&#xD;
&#xD;
          7. Females of childbearing potential must agree to utilize protocol recommended highly&#xD;
             effective contraceptive methods or be non-heterosexually active or practice sexual&#xD;
             abstinence from screening and throughout the duration of the study. Female subjects&#xD;
             who utilize hormonal contraceptive as one of their birth control methods must have&#xD;
             used the same method for at least 3 months prior to study drug dosing.&#xD;
&#xD;
          8. Male subjects must be willing to abstain from heterosexual intercourse or use a condom&#xD;
             throughout the study period.&#xD;
&#xD;
          9. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study.&#xD;
&#xD;
         10. Written informed consent must be obtained before any study procedure is performed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant or breastfeeding.&#xD;
&#xD;
          2. Any known allergies to any of the components of B/F/TAF.&#xD;
&#xD;
          3. Treatment with another investigational drug within three months of enrollment.&#xD;
&#xD;
          4. Abnormal hematological and biochemical parameters at screening, including:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) &lt; 750 cells/mm3.&#xD;
&#xD;
               2. Platelets &lt; 50,000/mm3.&#xD;
&#xD;
               3. Hemoglobin &lt; 8.5 g/dL.&#xD;
&#xD;
               4. AST or ALT of &gt; 5 times upper limit of normal (ULN).&#xD;
&#xD;
               5. Estimated GFR &lt; 30 mL/min/1.73 m2.&#xD;
&#xD;
               6. Total bilirubin &gt; 1.5 times ULN.&#xD;
&#xD;
          5. Previous or current history of malignancy, other than cutaneous Kaposi's sarcoma,&#xD;
             basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma.&#xD;
             Note: Those with a history of malignancy who are in remission for two or more years&#xD;
             may be included in the study.&#xD;
&#xD;
          6. An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior&#xD;
             to screening.&#xD;
&#xD;
          7. Subjects experiencing decompensated cirrhosis (e.g. ascites, encephalopathy, or&#xD;
             variceal bleeding).&#xD;
&#xD;
          8. Acute hepatitis in the 30 days prior to study entry.&#xD;
&#xD;
          9. Active tuberculosis infection.&#xD;
&#xD;
         10. Subjects receiving ongoing therapy with any medications contraindicated for&#xD;
             co-administration with B/F/TAF FDC, including but not limited to the following&#xD;
             medications: dofetilide, phenobarbital, phenytoin, carbamazepine, oxcarbamazepine,&#xD;
             rifampin, rifapentine, cisapride, St. John's Wort, and Echinaceae.&#xD;
&#xD;
         11. Current alcohol or substance use that in the opinion of the investigator may interfere&#xD;
             with subject study compliance.&#xD;
&#xD;
         12. Any other clinical conditions that in the opinion of the investigator would make the&#xD;
             subject unsuitable for the study or unable to comply with the dosing requirements.&#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>Joel V Chua, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Human Virology, University of Maryland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Human Virology Clinical Research Unit</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newlands Health</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <results_first_submitted>June 5, 2023</results_first_submitted>
  <results_first_submitted_qc>July 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 18, 2023</results_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Joel Chua</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>HIV-1</keyword>
  <keyword>Hepatitis B</keyword>
  <keyword>HIV-HBV coinfection</keyword>
  <keyword>Bictegravir</keyword>
  <keyword>B/F/TAF</keyword>
  <keyword>Tenofovir alafenamide</keyword>
  <keyword>Biktarvy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Coinfection</mesh_term>
    <mesh_term>Hepatitis</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>
    <mesh_term>Emtricitabine tenofovir alafenamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 16, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03797014/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 31, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03797014/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>B/F/TAF</title>
          <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>B/F/TAF</title>
          <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.1" lower_limit="28" upper_limit="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HIV RNA PCR &lt;50 copies/mL</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4 count &lt;200 cells/microliter</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HBV DNA PCR &lt;29 IU/mL</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HBeAg positive</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anti-HBe antibody positive</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Abnormal ALT</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hepatitis D antibody positive</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>HIV-1 RNA at Week 24</title>
        <description>Proportion of participants with HIV-1 RNA &lt;50 copies/mL at Week 24 by US FDA Snapshot Algorithm</description>
        <time_frame>Week 24</time_frame>
        <population>Intention-to-Treat (ITT) population: Enrolled subjects who received at least one study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>B/F/TAF</title>
            <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
          </group>
        </group_list>
        <measure>
          <title>HIV-1 RNA at Week 24</title>
          <description>Proportion of participants with HIV-1 RNA &lt;50 copies/mL at Week 24 by US FDA Snapshot Algorithm</description>
          <population>Intention-to-Treat (ITT) population: Enrolled subjects who received at least one study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>HBV DNA at Week 24</title>
        <description>Proportion of participants with plasma HBV DNA &lt;29 IU/mL at Week 24 as defined by Missing=Failure Approach</description>
        <time_frame>Week 24</time_frame>
        <population>Intention-to-Treat Population: All enrolled subjects who received at least one study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>B/F/TAF</title>
            <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
          </group>
        </group_list>
        <measure>
          <title>HBV DNA at Week 24</title>
          <description>Proportion of participants with plasma HBV DNA &lt;29 IU/mL at Week 24 as defined by Missing=Failure Approach</description>
          <population>Intention-to-Treat Population: All enrolled subjects who received at least one study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HIV-1 RNA at Week 48</title>
        <description>Proportion of participants with HIV-1 RNA &lt;50 copies/mL at Week 48 by US FDA Snapshot Algorithm</description>
        <time_frame>Week 48</time_frame>
        <population>Intention-to-Treat Population: All enrolled subjects who received at least one study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>B/F/TAF</title>
            <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
          </group>
        </group_list>
        <measure>
          <title>HIV-1 RNA at Week 48</title>
          <description>Proportion of participants with HIV-1 RNA &lt;50 copies/mL at Week 48 by US FDA Snapshot Algorithm</description>
          <population>Intention-to-Treat Population: All enrolled subjects who received at least one study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HBV DNA at Week 48</title>
        <description>Proportion of participants with plasma HBV DNA &lt;29 IU/mL at Week 48 as defined by Missing=Failure Approach</description>
        <time_frame>Week 48</time_frame>
        <population>Intention-to-Treat Population: All enrolled subjects who received at least one study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>B/F/TAF</title>
            <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
          </group>
        </group_list>
        <measure>
          <title>HBV DNA at Week 48</title>
          <description>Proportion of participants with plasma HBV DNA &lt;29 IU/mL at Week 48 as defined by Missing=Failure Approach</description>
          <population>Intention-to-Treat Population: All enrolled subjects who received at least one study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CD4 Cell Count Change at Week 24</title>
        <description>Change from baseline in CD4 cell count at Week 24</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>All enrolled subjects with CD4 count values at baseline and at week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>B/F/TAF</title>
            <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
          </group>
        </group_list>
        <measure>
          <title>CD4 Cell Count Change at Week 24</title>
          <description>Change from baseline in CD4 cell count at Week 24</description>
          <population>All enrolled subjects with CD4 count values at baseline and at week 24.</population>
          <units>cells/microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.8" spread="169.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CD4 Cell Count Change at Week 48</title>
        <description>Change from baseline in CD4 cell count at Week 48</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>All enrolled subjects with CD4 count results available at baseline and week 48.</population>
        <group_list>
          <group group_id="O1">
            <title>B/F/TAF</title>
            <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
          </group>
        </group_list>
        <measure>
          <title>CD4 Cell Count Change at Week 48</title>
          <description>Change from baseline in CD4 cell count at Week 48</description>
          <population>All enrolled subjects with CD4 count results available at baseline and week 48.</population>
          <units>cells/microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.6" spread="184.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ALT Normalization at Week 24</title>
        <description>Proportion of participants with normal ALT at Week 24</description>
        <time_frame>Week 24</time_frame>
        <population>Enrolled subjects with abnormal ALT at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>B/F/TAF</title>
            <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
          </group>
        </group_list>
        <measure>
          <title>ALT Normalization at Week 24</title>
          <description>Proportion of participants with normal ALT at Week 24</description>
          <population>Enrolled subjects with abnormal ALT at baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ALT Normalization at Week 48</title>
        <description>Proportion of participants with normal ALT at Week 48</description>
        <time_frame>Week 48</time_frame>
        <population>All enrolled subjects with abnormal baseline LFTs</population>
        <group_list>
          <group group_id="O1">
            <title>B/F/TAF</title>
            <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
          </group>
        </group_list>
        <measure>
          <title>ALT Normalization at Week 48</title>
          <description>Proportion of participants with normal ALT at Week 48</description>
          <population>All enrolled subjects with abnormal baseline LFTs</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HBeAg Loss at Week 48</title>
        <description>Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit.</description>
        <time_frame>Week 48</time_frame>
        <group_list>
          <group group_id="O1">
            <title>B/F/TAF</title>
            <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
          </group>
        </group_list>
        <measure>
          <title>HBeAg Loss at Week 48</title>
          <description>Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HBsAg Loss at Week 48</title>
        <description>Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit.</description>
        <time_frame>Week 48</time_frame>
        <group_list>
          <group group_id="O1">
            <title>B/F/TAF</title>
            <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
          </group>
        </group_list>
        <measure>
          <title>HBsAg Loss at Week 48</title>
          <description>Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected during the entire study participation (48 weeks).</time_frame>
      <desc>Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017).</desc>
      <group_list>
        <group group_id="E1">
          <title>B/F/TAF</title>
          <description>Treatment group (1-arm study)&#xD;
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (26.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abscess, extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study did not achieve its enrollment target of 60 and was adversely affected by COVID-19 pandemic travel and research restrictions particularly during April 2020 to August 2020.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Joel Chua</name_or_title>
      <organization>Institute of Human Virology, University of Maryland Baltimore</organization>
      <phone>14107065704</phone>
      <email>jchua@ihv.umaryland.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03797014
org study id: HP00083844
nct id: NCT03797014
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The primary objective of this study is to evaluate the efficacy and safety of fixed dose
      combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults
      coinfected with both HIV-1 and hepatitis B. As this is a switch study, all eligible subjects
      enrolled will be switched from their current antiretroviral regimen to B/F/TAF will be
      followed on treatment for 48 weeks.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is an open-label phase 4 switch study to evaluate the efficacy, safety, and tolerability of FDC B/F/TAF in adults with HIV-1 and HBV coinfection.
primary purpose: Treatment
masking: None (Open Label)
masking description: This is an open label study
measure: HIV-1 RNA at Week 24
time frame: Week 24
description: Proportion of participants with HIV-1 RNA <50 copies/mL at Week 24 by US FDA Snapshot Algorithm
measure: HBV DNA at Week 24
time frame: Week 24
description: Proportion of participants with plasma HBV DNA <29 IU/mL at Week 24 as defined by Missing=Failure Approach
measure: HIV-1 RNA at Week 48
time frame: Week 48
description: Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 by US FDA Snapshot Algorithm
measure: HBV DNA at Week 48
time frame: Week 48
description: Proportion of participants with plasma HBV DNA <29 IU/mL at Week 48 as defined by Missing=Failure Approach
measure: CD4 Cell Count Change at Week 24
time frame: Baseline; Week 24
description: Change from baseline in CD4 cell count at Week 24
measure: CD4 Cell Count Change at Week 48
time frame: Baseline; Week 48
description: Change from baseline in CD4 cell count at Week 48
measure: ALT Normalization at Week 24
time frame: Week 24
description: Proportion of participants with normal ALT at Week 24
measure: ALT Normalization at Week 48
time frame: Week 48
description: Proportion of participants with normal ALT at Week 48
measure: HBeAg Loss at Week 48
time frame: Week 48
description: Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit.
measure: HBsAg Loss at Week 48
time frame: Week 48
description: Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit.
arm group label: B/F/TAF
arm group type: Experimental
description: Treatment group (1-arm study)
intervention type: Drug
intervention name: B/F/TAF
description: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
arm group label: B/F/TAF
other name: Bictegravir/emtricitabine/tenofovir alafenamide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joel V Chua, MD
role: Principal Investigator
affiliation: Institute of Human Virology, University of Maryland
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Joel Chua
investigator title: Assistant Professor of Medicine
mesh term: Hepatitis B
mesh term: Coinfection
mesh term: Hepatitis
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Emtricitabine tenofovir alafenamide
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study did not achieve its enrollment target of 60 and was adversely affected by COVID-19 pandemic travel and research restrictions particularly during April 2020 to August 2020.
point of contact: 