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/NCT05996471</url>
    </required_header>
    <id_info>
      <org_study_id>209639</org_study_id>
      <nct_id>NCT05996471</nct_id>
    </id_info>
    <brief_title>A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)</brief_title>
    <acronym>EMBRACE</acronym>
    <official_title>A Phase 2b Multicenter, Randomized, Open-Label Study Comparing the Efficacy, Safety, PK, and Tolerability of VH3810109, Administered Either Intravenously Or As A Subcutaneous Infusion With rHuPH20, in Combination With CAB LA to Standard of Care in Virologically Suppressed Adults Living With HIV</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ViiV Healthcare</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ViiV Healthcare</source>
    <oversight_info>
      <has_dmc>No</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 study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing&#xD;
        schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant&#xD;
        hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in&#xD;
        accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy&#xD;
        (ART)-experienced adult participants living with HIV.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 17, 2023</start_date>
    <completion_date type="Anticipated">April 17, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 23, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Plasma HIV-1 Ribonucleic acid (RNA) Greater Than or Equal to (≥)50 Copies per Millilitre (c/mL) per Snapshot Algorithm at Month 6</measure>
      <time_frame>Month 6</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Serious Adverse Events (SAEs), Deaths, and Adverse Events (AEs) Leading to Discontinuation of Investigational Product (IP)</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Grade 3-4 AEs</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Laboratory Abnormalities</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Grade 1-4 Injection Site Reactions</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Meeting Confirmed Virologic Failure (CVF) Criteria Through Month 24</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Plasma HIV-1 RNA ≥50 c/mL per Snapshot Algorithm Over Time</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Plasma HIV-1 RNA Less Than (&lt;)50 c/mL per Snapshot Algorithm Over Time</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with HIV Disease Progression</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum Concentrations of VH3810109</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma Concentrations of Cabotegravir</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute Value for Cluster of Differentiation 4 (CD4+) T-Cell Count</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in CD4+ T-Cell Count</measure>
      <time_frame>Baseline (Day 1) and up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute Value for Cluster of Differentiation 8 (CD8+) T-Cell Count</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in CD8+ T-Cell Count</measure>
      <time_frame>Baseline (Day 1) up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Anti-VH3810109 Antibodies</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Neutralizing Antibodies Against VH3810109</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Treatment-emergent Genotypic Resistance</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Treatment-emergent Phenotypic Resistance</measure>
      <time_frame>Up to Month 24</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>HIV Infections</condition>
    <arm_group>
      <arm_group_label>Participants Receiving VH3810109 Plus Cabotegravir</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Participants Receiving VH3810109 Plus rHuPH20 Plus Cabotegravir</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Participants Receiving Standard of Care (SOC) Antiretroviral Therapy (ART)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>VH3810109</intervention_name>
      <description>VH3810109 will be administered.</description>
      <arm_group_label>Participants Receiving VH3810109 Plus Cabotegravir</arm_group_label>
      <arm_group_label>Participants Receiving VH3810109 Plus rHuPH20 Plus Cabotegravir</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cabotegravir</intervention_name>
      <description>Cabotegravir will be administered.</description>
      <arm_group_label>Participants Receiving VH3810109 Plus Cabotegravir</arm_group_label>
      <arm_group_label>Participants Receiving VH3810109 Plus rHuPH20 Plus Cabotegravir</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Standard of care (SOC)</intervention_name>
      <description>Pre-baseline SOC antiretroviral therapy (ART) will be administered.</description>
      <arm_group_label>Participants Receiving Standard of Care (SOC) Antiretroviral Therapy (ART)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>rHuPH20</intervention_name>
      <description>rHuPH20 will be administered.</description>
      <arm_group_label>Participants Receiving VH3810109 Plus rHuPH20 Plus Cabotegravir</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          •Participants must be on uninterrupted current regimen (either the initial or second&#xD;
          Antiretroviral (ARV) regimen) for at least 6 months prior to Screening. Any prior switch,&#xD;
          defined as a change of a single drug or multiple drugs simultaneously, must have occurred&#xD;
          due to tolerability/safety, access to medications, or convenience/simplification, and must&#xD;
          NOT have been done for treatment failure (HIV-1 RNA ≥200 c/mL).&#xD;
  &#xD;
          Acceptable stable (initial or second) ARV regimens prior to Screening include at least one&#xD;
          Nucleoside reverse transcriptase inhibitor (NRTI) plus:&#xD;
  &#xD;
            1. Integrase inhibitor (INI) (either the initial or second combination ART (cART)&#xD;
               regimen)&#xD;
  &#xD;
            2. Non-nucleoside reverse transcriptase inhibitors (NNRTI) (either the initial or second&#xD;
               cART regimen)&#xD;
  &#xD;
            3. Boosted Protease Inhibitor (PI) (or atazanavir [ATV] unboosted) (must be either the&#xD;
               initial cART regimen or one historical within class switch is permitted due to&#xD;
               safety/tolerability)&#xD;
  &#xD;
            4. Excludes current use of cabotegravir or fostemsavir&#xD;
  &#xD;
                 -  Documented evidence of at least two plasma HIV-1 RNA measurements &lt;50 c/mL in the&#xD;
                    12 months prior to Screening: one within the 6 to 12-month window, and one within&#xD;
                    6 months prior to Screening&#xD;
  &#xD;
                 -  Participants with plasma HIV-1 RNA &lt;50 c/mL at Screening&#xD;
  &#xD;
                 -  Screening CD4+ T-cell count ≥350 cells/cubic millimetre (mm^3)&#xD;
  &#xD;
                 -  Body weight ≥ 50 kilograms (kg) to ≤115 kg&#xD;
  &#xD;
                 -  QTc Interval &lt;450 milliseconds (msec)&#xD;
  &#xD;
                 -  Participants with viral phenotypic sensitivity to VH3810109 based on IC90 of ≤2&#xD;
                    micrograms (μg)/millilitre (mL) and a Maximum Percent Inhibition &gt;98% using the&#xD;
                    Monogram PhenoSense monoclonal antibody (mAb) Assay on sample obtained at a&#xD;
                    screening visit&#xD;
  &#xD;
                 -  Participants capable of giving signed informed consent which includes compliance&#xD;
                    with the requirements and restrictions listed in the informed consent form (ICF)&#xD;
                    and in this protocol&#xD;
  &#xD;
                 -  Participants female at birth should either not be of childbearing potential or&#xD;
                    using acceptable contraceptive method&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants who are pregnant, breastfeeding, plan to become pregnant or breastfeed&#xD;
               during the study&#xD;
  &#xD;
            -  Participants having skin disease or disorder (i.e. infection, inflammation,&#xD;
               dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) or&#xD;
               tattoo overlying potential injection sites which may interfere with interpretation of&#xD;
               injection site reactions or administration of VH3810109 or CAB&#xD;
  &#xD;
            -  Participant has a gluteal implant/enhancement (including fillers) overlying the&#xD;
               gluteus area or any other area which may significantly interfere with interpretation&#xD;
               of injection site reactions&#xD;
  &#xD;
            -  Participants with known history of cirrhosis with or without viral hepatitis&#xD;
               co-infection&#xD;
  &#xD;
            -  Participants with ongoing or clinically relevant pancreatitis&#xD;
  &#xD;
            -  Untreated syphilis infection (positive rapid plasma reagin (RPR) at screening) without&#xD;
               documentation of treatment. Participants who are at least 7 days post completed&#xD;
               treatment are eligible if recruitment is open&#xD;
  &#xD;
            -  Prior receipt of licensed or investigational HIV monoclonal antibody&#xD;
  &#xD;
            -  Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3&#xD;
               disease except cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical&#xD;
               or current CD4 cell counts less than 200 cells/mm^3 are not exclusionary&#xD;
  &#xD;
            -  History of sensitivity to any of the study medications or their components or drugs of&#xD;
               their class, or a history of drug or other allergy that, in the opinion of the&#xD;
               investigator or Medical Monitor, contraindicates their participation&#xD;
  &#xD;
            -  Any condition which, in the opinion of the investigator, may interfere with the&#xD;
               absorption, distribution, metabolism or excretion of the study drugs, cART or render&#xD;
               the participant unable to take oral medication&#xD;
  &#xD;
            -  Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening&#xD;
  &#xD;
            -  Previous exposure to cabotegravir&#xD;
  &#xD;
            -  Participant enrolled in a prior or concurrent clinical study that includes a drug&#xD;
               intervention within the last 30 days&#xD;
  &#xD;
            -  Participants with ongoing chronic hepatitis B virus infection&#xD;
  &#xD;
            -  Participants with hepatitis C co-infection&#xD;
  &#xD;
            -  Participants who in the investigator's judgment, pose a significant suicidality risk&#xD;
  &#xD;
            -  Participants with a positive coronavirus disease- 2019 (COVID-19) test at screening&#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_contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>EU GSK Clinical Trials Call Center</last_name>
      <phone>+44 (0) 20 89904466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Birmingham</city>
          <state>Alabama</state>
          <zip>35294</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>Sonya Heath</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Bakersfield</city>
          <state>California</state>
          <zip>93301</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90027</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>William J. Towner</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Palm Springs</city>
          <state>California</state>
          <zip>92262</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Sacramento</city>
          <state>California</state>
          <zip>95825</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94110</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06510</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20007</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20037</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>Marc Siegel</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Fort Lauderdale</city>
          <state>Florida</state>
          <zip>33308</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>Zackary Henry</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Fort Pierce</city>
          <state>Florida</state>
          <zip>34982</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>Moti N Ramgopal</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33133</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32803</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Pensacola</city>
          <state>Florida</state>
          <zip>32504</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Sarasota</city>
          <state>Florida</state>
          <zip>34237</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>Tanya Schreibman</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Vero Beach</city>
          <state>Florida</state>
          <zip>32960</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>West Palm Beach</city>
          <state>Florida</state>
          <zip>33401</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Decatur</city>
          <state>Georgia</state>
          <zip>30033</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Springfield</city>
          <state>Massachusetts</state>
          <zip>01105</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Southfield</city>
          <state>Michigan</state>
          <zip>48075</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>Vilma Drelichman</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Columbia</city>
          <state>Missouri</state>
          <zip>65212</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Newark</city>
          <state>New Jersey</state>
          <zip>07102</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Albuquerque</city>
          <state>New Mexico</state>
          <zip>87109</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Santa Fe</city>
          <state>New Mexico</state>
          <zip>87505</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Bronx</city>
          <state>New York</state>
          <zip>10461</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Bronx</city>
          <state>New York</state>
          <zip>10467</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Manhasset</city>
          <state>New York</state>
          <zip>11030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10029</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10032</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Greensboro</city>
          <state>North Carolina</state>
          <zip>27401-1209</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45267</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97239</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>William Short</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37208</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78705</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75246</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>El Paso</city>
          <state>Texas</state>
          <zip>79835</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030-1501</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77098</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Milwaukee</city>
          <state>Wisconsin</state>
          <zip>53226</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>San Juan</city>
          <zip>00909</zip>
          <country>Puerto Rico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
      <investigator>
        <last_name>Lizette Santiago-Colón</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>San Juan</city>
          <zip>909</zip>
          <country>Puerto Rico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
        <phone>877-379-3718</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact>
      <contact_backup>
        <last_name>EU GSK Clinical Trials Call Centre</last_name>
        <phone>+44 (0) 20 8990 4466</phone>
        <email>GSKClinicalSupportHD@gsk.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Puerto Rico</country>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>VH3810109</keyword>
    <keyword>Cabotegravir</keyword>
    <keyword>Standard of care</keyword>
    <keyword>HIV</keyword>
    <keyword>Long acting</keyword>
    <keyword>Virologically Suppressed</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Infections</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cabotegravir</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.</ipd_time_frame>
      <ipd_access_criteria>Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.</ipd_access_criteria>
      <ipd_url>https://www.gsk.com/en-gb/innovation/trials/data-transparency/</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/NCT05996471
  org study id: 209639
  nct id: NCT05996471
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing
        schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant
        hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in
        accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy
        (ART)-experienced adult participants living with HIV.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants with Plasma HIV-1 Ribonucleic acid (RNA) Greater Than or Equal to (≥)50 Copies per Millilitre (c/mL) per Snapshot Algorithm at Month 6
  time frame: Month 6
  measure: Number of Participants with Serious Adverse Events (SAEs), Deaths, and Adverse Events (AEs) Leading to Discontinuation of Investigational Product (IP)
  time frame: Up to Month 24
  measure: Number of Participants with Grade 3-4 AEs
  time frame: Up to Month 24
  measure: Number of Participants with Laboratory Abnormalities
  time frame: Up to Month 24
  measure: Number of Participants with Grade 1-4 Injection Site Reactions
  time frame: Up to Month 24
  measure: Number of Participants Meeting Confirmed Virologic Failure (CVF) Criteria Through Month 24
  time frame: Up to Month 24
  measure: Number of Participants with Plasma HIV-1 RNA ≥50 c/mL per Snapshot Algorithm Over Time
  time frame: Up to Month 24
  measure: Number of Participants with Plasma HIV-1 RNA Less Than (<)50 c/mL per Snapshot Algorithm Over Time
  time frame: Up to Month 24
  measure: Number of Participants with HIV Disease Progression
  time frame: Up to Month 24
  measure: Serum Concentrations of VH3810109
  time frame: Up to Month 24
  measure: Plasma Concentrations of Cabotegravir
  time frame: Up to Month 24
  measure: Absolute Value for Cluster of Differentiation 4 (CD4+) T-Cell Count
  time frame: Up to Month 24
  measure: Change From Baseline in CD4+ T-Cell Count
  time frame: Baseline (Day 1) and up to Month 24
  measure: Absolute Value for Cluster of Differentiation 8 (CD8+) T-Cell Count
  time frame: Up to Month 24
  measure: Change From Baseline in CD8+ T-Cell Count
  time frame: Baseline (Day 1) up to Month 24
  measure: Number of Participants with Anti-VH3810109 Antibodies
  time frame: Up to Month 24
  measure: Number of Participants with Neutralizing Antibodies Against VH3810109
  time frame: Up to Month 24
  measure: Number of Participants with Treatment-emergent Genotypic Resistance
  time frame: Up to Month 24
  measure: Number of Participants with Treatment-emergent Phenotypic Resistance
  time frame: Up to Month 24
  arm group label: Participants Receiving VH3810109 Plus Cabotegravir
  arm group type: Experimental
  arm group label: Participants Receiving VH3810109 Plus rHuPH20 Plus Cabotegravir
  arm group type: Experimental
  arm group label: Participants Receiving Standard of Care (SOC) Antiretroviral Therapy (ART)
  arm group type: Active Comparator
  intervention type: Biological
  intervention name: VH3810109
  description: VH3810109 will be administered.
  arm group label: Participants Receiving VH3810109 Plus Cabotegravir
  arm group label: Participants Receiving VH3810109 Plus rHuPH20 Plus Cabotegravir
  intervention type: Drug
  intervention name: Cabotegravir
  description: Cabotegravir will be administered.
  arm group label: Participants Receiving VH3810109 Plus Cabotegravir
  arm group label: Participants Receiving VH3810109 Plus rHuPH20 Plus Cabotegravir
  intervention type: Drug
  intervention name: Standard of care (SOC)
  description: Pre-baseline SOC antiretroviral therapy (ART) will be administered.
  arm group label: Participants Receiving Standard of Care (SOC) Antiretroviral Therapy (ART)
  intervention type: Biological
  intervention name: rHuPH20
  description: rHuPH20 will be administered.
  arm group label: Participants Receiving VH3810109 Plus rHuPH20 Plus Cabotegravir
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: US GSK Clinical Trials Call Center
  phone: 877-379-3718
  email: GSKClinicalSupportHD@gsk.com
  last name: EU GSK Clinical Trials Call Center
  phone: +44 (0) 20 89904466
  email: GSKClinicalSupportHD@gsk.com
  facility: 
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  country: Puerto Rico
  country: United States
  responsible party type: Sponsor
  mesh term: HIV Infections
  mesh term: Cabotegravir
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
  ipd access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
  ipd url: https://www.gsk.com/en-gb/innovation/trials/data-transparency/