xml: <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/NCT06032546</url>
    </required_header>
    <id_info>
      <org_study_id>M19-965</org_study_id>
      <secondary_id>2023-505900-53-00</secondary_id>
      <nct_id>NCT06032546</nct_id>
    </id_info>
    <brief_title>A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion of Budigalimab and/or ABBV-382</brief_title>
    <official_title>A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Budigalimab and/or ABBV-382 in People Living With HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AbbVie</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AbbVie</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>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency&#xD;
        Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong&#xD;
        therapy. The purpose of this study is to assess change in disease activity, adverse events,&#xD;
        tolerability, and how the drug moves through the body.&#xD;
  &#xD;
        Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV&#xD;
        disease. Participants are placed in 1 of 5 groups, called treatment arms. Each group receives&#xD;
        a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo&#xD;
        (A placebo is not a drug and it is not expected to have any chemical effects on your body and&#xD;
        it is not designed to treat any disease or illness). Approximately 140 adult participants&#xD;
        living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical&#xD;
        Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide.&#xD;
  &#xD;
        Participants will receive 4 doses of IV budigalimab or placebo combined with 3 doses of IV&#xD;
        ABBV-382 or placebo for an 8 week dosing period. Participants need to be stable on&#xD;
        antiretroviral therapy to participate in the study. If participant qualifies to the study, on&#xD;
        the day they receive the first injection, participants will be asked to stop antiretroviral&#xD;
        medications (also referred to as analytical treatment interruption or ATI) for 52 weeks or&#xD;
        until meeting specific criteria to restart antiretroviral medications. Participants will&#xD;
        undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes&#xD;
        participant's request. Participants will be followed for up to approximately 52 weeks.&#xD;
  &#xD;
        There may be higher treatment burden for participants in this trial compared to their&#xD;
        standard of care. Participants will attend regular visits during the study at a hospital or&#xD;
        clinic. There will be an option for virtual or home health visits for some of the follow-up&#xD;
        visits. The effect of the treatment will be checked by medical assessments, blood tests,&#xD;
        checking for side effects and completing questionnaires.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 3, 2023</start_date>
    <completion_date type="Anticipated">November 18, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 5, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart</measure>
      <time_frame>Week 24</time_frame>
      <description>Percentage of participants who achieve viral control (viral load &lt; 1000 copies/mL) without ART restart at Week 24.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Median Peak Viral Load (At Rebound) Prior to Re-Starting ART</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>The median peak viral load (at rebound) before re-starting ART.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median Time to First Rebound to &gt;= 1000 Copies/mL During ART Interruption</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>The median time to rebound to &gt;= 1000 copies/mL during ART interruption.</description>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Human Immuno-deficiency Virus (HIV) Disease</condition>
    <arm_group>
      <arm_group_label>Arm A: Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive budigalimab placebo on Day 1, and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo on Day 1 and Weeks 4 and 8.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B: Budigalimab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive budigalimab on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo Day 1 and Weeks 4 and 8.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm C: ABBV-382 Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive budigalimab placebo on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm D: Budigalimab + ABBV-382 Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive budigalimab on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose B on Day 1 and Weeks 4 and 8.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm E: Budigalimab + ABBV-382 Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive budigalimab on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Budigalimab</intervention_name>
      <description>IV</description>
      <arm_group_label>Arm B: Budigalimab</arm_group_label>
      <arm_group_label>Arm D: Budigalimab + ABBV-382 Dose B</arm_group_label>
      <arm_group_label>Arm E: Budigalimab + ABBV-382 Dose A</arm_group_label>
      <other_name>ABBV-181</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo for Budigalimab</intervention_name>
      <description>IV</description>
      <arm_group_label>Arm A: Placebo</arm_group_label>
      <arm_group_label>Arm C: ABBV-382 Dose A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ABBV-382</intervention_name>
      <description>IV</description>
      <arm_group_label>Arm C: ABBV-382 Dose A</arm_group_label>
      <arm_group_label>Arm D: Budigalimab + ABBV-382 Dose B</arm_group_label>
      <arm_group_label>Arm E: Budigalimab + ABBV-382 Dose A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo for ABBV-382</intervention_name>
      <description>IV</description>
      <arm_group_label>Arm A: Placebo</arm_group_label>
      <arm_group_label>Arm B: Budigalimab</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A condition of general good health in the opinion of the investigator, based upon the&#xD;
               results of a medical history, physical examination, vital signs, laboratory profile,&#xD;
               and a 12-lead electrocardiogram (ECG).&#xD;
  &#xD;
            -  Must be on antiretroviral therapy (ART) for at least 12 months prior to screening and&#xD;
               on current ART regimen for at least 8 weeks prior to screening (current ART regimen&#xD;
               cannot include an Non-nucleoside reverse transcriptase inhibitor [NNRTI]).&#xD;
  &#xD;
            -  Negative human immuno-deficiency virus (HIV)-2 antibody (Ab)&#xD;
  &#xD;
            -  CD4+ T cell count &gt;= 500 cells/μL at screening and no known evidence of CD4+ T cell&#xD;
               count &lt; 500 cells/μL in the last 12 months prior to screening&#xD;
  &#xD;
            -  Participant must have plasma HIV-1 ribonucleic acid (RNA) below the lower limit of&#xD;
               quantitation (LLOQ) at screening and for at least 6 months prior to screening&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Clinically significant medical disorders per investigator's assessment that might&#xD;
               expose the participants to undue risk of harm, confound study outcomes, or prevent the&#xD;
               participant from completing the study.&#xD;
  &#xD;
            -  Prior exposure to long acting antiretrovirals within 24 weeks or within a period&#xD;
               defined by 5 half-lives, whichever is longer, prior to randomization and prior to the&#xD;
               first dose of study drug.&#xD;
  &#xD;
            -  Known history of cluster of differentiation 4 (CD4+) T cell nadir of &lt;= 200 cells/μL&#xD;
               during chronic HIV infection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ABBVIE INC.</last_name>
      <role>Study Director</role>
      <affiliation>AbbVie</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ABBVIE CALL CENTER</last_name>
      <phone>844-663-3742</phone>
      <email>abbvieclinicaltrials@abbvie.com</email>
    </overall_contact>
    <link>
      <url>https://www.abbvieclinicaltrials.com/study/?id=M19-965</url>
      <description>Related Info</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Human immuno-deficiency virus (HIV) Disease</keyword>
    <keyword>Budigalimab</keyword>
    <keyword>ABBV-382</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
      <mesh_term>HIV Infections</mesh_term>
      <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
      <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
      <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032546
  org study id: M19-965
  secondary id: 2023-505900-53-00
  nct id: NCT06032546
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency
        Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong
        therapy. The purpose of this study is to assess change in disease activity, adverse events,
        tolerability, and how the drug moves through the body.
  
        Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV
        disease. Participants are placed in 1 of 5 groups, called treatment arms. Each group receives
        a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo
        (A placebo is not a drug and it is not expected to have any chemical effects on your body and
        it is not designed to treat any disease or illness). Approximately 140 adult participants
        living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical
        Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide.
  
        Participants will receive 4 doses of IV budigalimab or placebo combined with 3 doses of IV
        ABBV-382 or placebo for an 8 week dosing period. Participants need to be stable on
        antiretroviral therapy to participate in the study. If participant qualifies to the study, on
        the day they receive the first injection, participants will be asked to stop antiretroviral
        medications (also referred to as analytical treatment interruption or ATI) for 52 weeks or
        until meeting specific criteria to restart antiretroviral medications. Participants will
        undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes
        participant's request. Participants will be followed for up to approximately 52 weeks.
  
        There may be higher treatment burden for participants in this trial compared to their
        standard of care. Participants will attend regular visits during the study at a hospital or
        clinic. There will be an option for virtual or home health visits for some of the follow-up
        visits. The effect of the treatment will be checked by medical assessments, blood tests,
        checking for side effects and completing questionnaires.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart
  time frame: Week 24
  description: Percentage of participants who achieve viral control (viral load < 1000 copies/mL) without ART restart at Week 24.
  measure: Median Peak Viral Load (At Rebound) Prior to Re-Starting ART
  time frame: Up to 52 weeks
  description: The median peak viral load (at rebound) before re-starting ART.
  measure: Median Time to First Rebound to >= 1000 Copies/mL During ART Interruption
  time frame: Up to 52 weeks
  description: The median time to rebound to >= 1000 copies/mL during ART interruption.
  arm group label: Arm A: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive budigalimab placebo on Day 1, and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo on Day 1 and Weeks 4 and 8.
  arm group label: Arm B: Budigalimab
  arm group type: Experimental
  description: Participants will receive budigalimab on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo Day 1 and Weeks 4 and 8.
  arm group label: Arm C: ABBV-382 Dose A
  arm group type: Experimental
  description: Participants will receive budigalimab placebo on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.
  arm group label: Arm D: Budigalimab + ABBV-382 Dose B
  arm group type: Experimental
  description: Participants will receive budigalimab on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose B on Day 1 and Weeks 4 and 8.
  arm group label: Arm E: Budigalimab + ABBV-382 Dose A
  arm group type: Experimental
  description: Participants will receive budigalimab on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.
  intervention type: Drug
  intervention name: Budigalimab
  description: IV
  arm group label: Arm B: Budigalimab
  arm group label: Arm D: Budigalimab + ABBV-382 Dose B
  arm group label: Arm E: Budigalimab + ABBV-382 Dose A
  other name: ABBV-181
  intervention type: Drug
  intervention name: Placebo for Budigalimab
  description: IV
  arm group label: Arm A: Placebo
  arm group label: Arm C: ABBV-382 Dose A
  intervention type: Drug
  intervention name: ABBV-382
  description: IV
  arm group label: Arm C: ABBV-382 Dose A
  arm group label: Arm D: Budigalimab + ABBV-382 Dose B
  arm group label: Arm E: Budigalimab + ABBV-382 Dose A
  intervention type: Drug
  intervention name: Placebo for ABBV-382
  description: IV
  arm group label: Arm A: Placebo
  arm group label: Arm B: Budigalimab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: ABBVIE INC.
  role: Study Director
  affiliation: AbbVie
  last name: ABBVIE CALL CENTER
  phone: 844-663-3742
  email: abbvieclinicaltrials@abbvie.com
  url: https://www.abbvieclinicaltrials.com/study/?id=M19-965
  description: Related Info
  responsible party type: Sponsor
  mesh term: Acquired Immunodeficiency Syndrome
  mesh term: HIV Infections
  mesh term: Immunologic Deficiency Syndromes
  sharing ipd: Yes
  ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
  ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
  ipd url: https://vivli.org/ourmember/abbvie/