<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/NCT04493216</url>
  </required_header>
  <id_info>
    <org_study_id>208379</org_study_id>
    <nct_id>NCT04493216</nct_id>
  </id_info>
  <brief_title>A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults</brief_title>
  <acronym>DOMINO</acronym>
  <official_title>A Phase IIb, Randomized, Partially Blind, Active Controlled, Dose-range Finding Study of GSK3640254 Compared to a Reference Arm of Dolutegravir, Each in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1 Infected Antiretroviral Treatment-naive Adults</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>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254&#xD;
      doses [100, 150 and 200 milligrams {mg}]), active controlled clinical trial. It will aim to&#xD;
      investigate the safety, efficacy and dose-response of GSK3640254 compared to dolutegravir&#xD;
      (DTG), each given in combination with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs)&#xD;
      (abacavir/lamivudine [ABC/3TC] or emtricitabine/tenofovir alafenamide [FTC/TAF])&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 18, 2020</start_date>
  <completion_date type="Anticipated">October 23, 2028</completion_date>
  <primary_completion_date type="Actual">September 5, 2022</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>
    <intervention_model_description>This is a randomized, multicenter, parallel group study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The study treatment assignments will not be blinded (GSK3640254 versus Dolutegravir control arm). However, the dose level of GSK3640254 in each of the treatment arms containing GSK3640254 will be blinded to the research participants and all study personnel during the study. The Sponsor personnel will also remain blinded until the database lock for the Week 24 analysis.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants with plasma HIV-1 ribonucleic acid (RNA) &lt;50 copies per milliliter (c/mL) at Week 24</measure>
    <time_frame>At Week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with plasma HIV-1 RNA &lt;50 c/mL at Weeks 48 and 96</measure>
    <time_frame>At Weeks 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute values of HIV-1 RNA at Weeks 24, 48 and 96</measure>
    <time_frame>At Weeks 24, 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in plasma HIV-1 RNA at Weeks 24, 48 and 96 (c/mL)</measure>
    <time_frame>Baseline and at Weeks 24, 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute values of Cluster of differentiation 4 plus (CD4+) cell counts at Weeks 24, 48 and 96</measure>
    <time_frame>At Weeks 24, 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in CD4+ cell counts at Weeks 24, 48 and 96 (Cells per cubic millimeters [cells/mm^3])</measure>
    <time_frame>Baseline and at Weeks 24, 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Adverse events (AEs), serious adverse events (SAEs), Deaths and adverse events (AEs) leading to treatment discontinuation at Weeks 24, 48 and 96</measure>
    <time_frame>At Weeks 24, 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of AEs at Weeks 24, 48 and 96</measure>
    <time_frame>At Weeks 24, 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who develop phenotypic and genotypic resistance resistance at Weeks 24, 48 and 96</measure>
    <time_frame>At Weeks 24, 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed concentration (Cmax) of GSK3640254 at steady state at Weeks 24 and 48</measure>
    <time_frame>At Weeks 24 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC over the dosing interval (AUC [0-tau]) of GSK3640254 at Weeks 24 and 48</measure>
    <time_frame>At Weeks 24 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration at the end of the dosing (Ctau) of GSK3640254 at steady state at Weeks 24 and 48</measure>
    <time_frame>At Weeks 24 and 48</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">161</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Blinded GSK3640254 150 mg + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Open Label DTG + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK3640254</intervention_name>
    <description>GSK3640254 will be available as a 25 mg and 100 mg tablets to be administered via oral route.</description>
    <arm_group_label>Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_label>Blinded GSK3640254 150 mg + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_label>Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABC/3TC</intervention_name>
    <description>ABC/3TC will be available as abacavir 600 mg/lamivudine 300 mg tablet to be administered via oral route.</description>
    <arm_group_label>Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_label>Blinded GSK3640254 150 mg + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_label>Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_label>Open Label DTG + Open Label ABC/3TC or FTC/TAF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FTC/TAF</intervention_name>
    <description>FTC/TAF will be available as emtricitabine 200 mg/tenofovir alafenamide 25 mg tablet to be administered via oral route.</description>
    <arm_group_label>Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_label>Blinded GSK3640254 150 mg + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_label>Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_label>Open Label DTG + Open Label ABC/3TC or FTC/TAF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dolutegravir</intervention_name>
    <description>Dolutegravir will be available as a 50 mg tablet to be administered via oral route.</description>
    <arm_group_label>Open Label DTG + Open Label ABC/3TC or FTC/TAF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching GSK3640254 will be administered in the form of tablets via oral route.</description>
    <arm_group_label>Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF</arm_group_label>
    <arm_group_label>Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be 18 years of age inclusive, at the time of signing the informed&#xD;
             consent.&#xD;
&#xD;
          -  Treatment-naive, defined as no anti-retrovirals (ARVs) (in combination or monotherapy)&#xD;
             received after the diagnosis of HIV-1 infection (for example [e.g.], use of&#xD;
             Pre-exposure prophylaxis [PreP] meets inclusion.&#xD;
&#xD;
          -  Documented HIV infection and Screening plasma HIV-1 RNA greater than or equal to&#xD;
             (&gt;=)1000 c/mL.&#xD;
&#xD;
          -  Screening CD4+ T-cell count &gt;=250 cells/mm^3.&#xD;
&#xD;
          -  Antiviral susceptibility to the NRTI backbone selected should be demonstrated&#xD;
&#xD;
          -  Body weight &gt;=50.0 kilograms (kg) (110 pounds [lbs]) for men and &gt;=45.0 kg (99 lbs)&#xD;
             for women and body mass index (BMI) greater than (&gt;)18.5 kg/meter square&#xD;
             (m^2).Calculations will utilize sex assigned at birth&#xD;
&#xD;
          -  Participants who are male at birth and participants who are female at birth.&#xD;
&#xD;
          -  Participants who are female at birth: Contraceptive use by participant who are female&#xD;
             at birth should be consistent with local regulations regarding the methods of&#xD;
             contraception for those participating in clinical studies.&#xD;
&#xD;
             • A participant who is female at birth is eligible to participate if they are not&#xD;
             pregnant or breastfeeding, and one of the following conditions applies:&#xD;
&#xD;
               -  Is a participant of non-childbearing potential (PONCBP)&#xD;
&#xD;
               -  Or is a POCBP and using an acceptable contraceptive method during the study&#xD;
                  intervention period (at a minimum until after the last dose of study&#xD;
                  intervention).&#xD;
&#xD;
          -  Capable of giving signed informed consent which includes compliance with the&#xD;
             requirements and restrictions listed in the informed consent form (ICF) and in this&#xD;
             protocol.&#xD;
&#xD;
          -  For participants enrolled in France: a participant will be eligible for inclusion in&#xD;
             this study only if either affiliated to or a beneficiary of a social security&#xD;
             category.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Any evidence of an active Center for Disease Control and Prevention (CDC) Stage 3&#xD;
             disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy.&#xD;
&#xD;
          -  Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or&#xD;
             resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile&#xD;
             intraepithelial neoplasia.&#xD;
&#xD;
          -  Presence of primary HIV-1 infection, evidenced by acute retroviral syndrome (e.g.,&#xD;
             fever, malaise, fatigue) and/or evidence of recent (within 3 months) documented&#xD;
             viremia without antibody production and/or evidence of recent (within 3 months)&#xD;
             documented seroconversion.&#xD;
&#xD;
          -  Known history of liver cirrhosis with or without viral hepatitis co-infection.&#xD;
&#xD;
          -  Unstable liver disease (as defined by any of the following: presence of ascites,&#xD;
             encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or&#xD;
             persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of&#xD;
             Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver&#xD;
             disease per investigator assessment).&#xD;
&#xD;
          -  History of ongoing or clinically relevant hepatitis within the previous 6 months.&#xD;
&#xD;
          -  History of drug or other allergy that, in the opinion of the Investigator or Medical&#xD;
             Monitor, contraindicates their participation.&#xD;
&#xD;
          -  Any history of significant underlying psychiatric disorder, in the opinion of the&#xD;
             Investigator or ViiV Medical Monitor, including but not limited to schizophrenia,&#xD;
             bipolar disorder with or without psychotic symptoms, other psychotic disorders, or&#xD;
             schizotypal (personality) disorder or a clinical assessment of suicidality based on&#xD;
             the responses on the Columbia-Suicide Severity Rating Scale (eCSSRS).&#xD;
&#xD;
          -  Any history of major depressive disorder with or without suicidal features, or anxiety&#xD;
             disorders, that required medical intervention (pharmacologic or not) such as&#xD;
             hospitalization or other inpatient treatment and/or chronic (&gt;6 months) outpatient&#xD;
             treatment.&#xD;
&#xD;
          -  Any pre-existing physical or other psychiatric condition (including alcohol or drug&#xD;
             abuse), which, in the opinion of the Investigator or ViiV Medical Monitor (with or&#xD;
             without psychiatric evaluation), could interfere with the participant's ability to&#xD;
             comply with the dosing schedule and protocol evaluations or which might compromise the&#xD;
             safety of the participant.&#xD;
&#xD;
          -  A pre-existing condition, in the opinion of the Investigator or ViiV Medical Monitor,&#xD;
             that could interfere with normal gastrointestinal anatomy or motility (e.g.,&#xD;
             gastroesophageal reflux disease [GERD], gastric ulcers, gastritis, inflammatory bowel&#xD;
             disease), hepatic and/or renal function, or with the absorption, metabolism, and/or&#xD;
             excretion of the study drugs or render the participant unable to take oral study&#xD;
             treatment.&#xD;
&#xD;
          -  Myocardial infarction in the past 3 months.&#xD;
&#xD;
          -  Familial or personal history of long QT syndrome or sudden cardiac death.&#xD;
&#xD;
          -  Medical history, current or historical, of significant cardiac arrhythmias or&#xD;
             Electrocardiogram (ECG) findings which, in the opinion of the Investigator or ViiV&#xD;
             Medical Monitor, will interfere with the safety of the participant.&#xD;
&#xD;
          -  Active Treatment for a viral infection other than HIV-1, such as Hepatitis B, with an&#xD;
             agent that is active against HIV-1 (were known to be infected with HIV-1 after&#xD;
             treatment for Hepatitis B was completed).&#xD;
&#xD;
          -  Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.&#xD;
&#xD;
          -  Treatment with any of the following agents within 28 days of Screening: radiation&#xD;
             therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.&#xD;
&#xD;
          -  Participants receiving any protocol-prohibited medication and who are unwilling or&#xD;
             unable to switch to an alternate medication.&#xD;
&#xD;
          -  Participants who are unwilling to stop any medications as required by the local lab&#xD;
             test for Helicobacter (H.) pylori.&#xD;
&#xD;
          -  Participants who require concomitant medications known to be associated with a&#xD;
             prolonged Corrected QT interval (QTc).&#xD;
&#xD;
          -  Exposure to an experimental drug, human blood product, monoclonal antibody, or vaccine&#xD;
             (which does not have emergency, conditional or standard market authorization) within&#xD;
             28 days prior to the first dose of study treatment.&#xD;
&#xD;
          -  Current enrollment or past participation within the last 30 days before signing of&#xD;
             consent in any other clinical study involving an investigational study intervention&#xD;
             (including an investigational Coronavirus Disease (COVID) vaccine) or any other type&#xD;
             of medical research.&#xD;
&#xD;
          -  Any evidence of viral resistance based on the NRTI backbone selected.&#xD;
&#xD;
          -  Historical evidence (prior to study screening period) of the presence of resistance-&#xD;
             associated mutations gag A364V or A364A/V.&#xD;
&#xD;
          -  Creatinine Clearance &lt;50 mL/minute.&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) &gt;=3 times upper limit of normal (ULN) or ALT &gt;=2 times&#xD;
             ULN and total bilirubin &gt;=1.5 times ULN.&#xD;
&#xD;
          -  Evidence of Hepatitis B virus (HBV) infection based on the results of testing for&#xD;
             Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B&#xD;
             surface antibody (anti-HBs) and reflex HBV deoxyribonucleic acid (DNA) as follows:&#xD;
&#xD;
               1. Participants positive for HBsAg are excluded;&#xD;
&#xD;
               2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg&#xD;
                  status) and positive for HBV DNA on reflex testing are excluded.&#xD;
&#xD;
          -  Positive Hepatitis C antibody test result at Screening and positive on reflex to&#xD;
             Hepatitis C RNA.&#xD;
&#xD;
          -  Positive test results for H. pylori;&#xD;
&#xD;
          -  Known or suspected active COVID-19 infection or contact with an individual with known&#xD;
             COVID-19, within 14 days of study enrollment&#xD;
&#xD;
          -  Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening) without&#xD;
             documentation of treatment.&#xD;
&#xD;
          -  Presence of moderate-to-severe hepatic impairment (Class B or C) as determined by&#xD;
             Child-Pugh classification.&#xD;
&#xD;
          -  Any acute laboratory abnormality at Screening, which, in the opinion of the&#xD;
             investigator or ViiV Medical Monitor, would preclude participation in the study of an&#xD;
             investigational compound.&#xD;
&#xD;
          -  Urine Drug Screen positive (showing presence of): Amphetamines, Barbiturates, Cocaine,&#xD;
             3,4-Methyl enedioxy methamphetamine (MDMA) or Phencyclidine, or non-prescribed&#xD;
             opiates, oxycodone, benzodiazepines, methadone, methamphetamines or tricyclic&#xD;
             antidepressants.&#xD;
&#xD;
          -  Any clinically relevant Grade 4 laboratory abnormality at Screen, including results&#xD;
             for creatine phosphokinase (CPK) and lipid abnormalities that lack a compelling&#xD;
             explanation from the Investigator.&#xD;
&#xD;
          -  Where participation in the study would result in donation of blood or blood products&#xD;
             in excess of 500 mL within 28 days.&#xD;
&#xD;
          -  Exposure to more than 4 new investigational drugs or vaccines (exclusive of a severe&#xD;
             acute respiratory syndrome coronavirus 2 (SARS-CoV-2) potential indication within 12&#xD;
             months prior to the first dosing day;&#xD;
&#xD;
          -  Treatment with radiation therapy or cytotoxic chemotherapeutic agents or any systemic&#xD;
             immunosuppressive agent within 30 days of study drug administration or anticipated&#xD;
             need for such treatment within the study;&#xD;
&#xD;
          -  ECG Heart Rate &lt;50 beats per minute (bpm) or &gt;100 bpm, or QT duration corrected for&#xD;
             heart rate by Fridericia's formula (QTcF) &gt;450 milliseconds (msec).&#xD;
&#xD;
          -  For Portugal only: HIV-2 infection (either determined by prior testing, medical&#xD;
             history, or obtained locally during the Screening window).&#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>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>ViiV Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berkley</city>
        <state>Michigan</state>
        <zip>48072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216-4505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267-0405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1128AAF</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1207AAP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1425AGC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1425AWK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1405CKC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1202ABB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1141</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Juan</city>
        <zip>5400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4P9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Marseille</city>
        <zip>13003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tourcoing cedex</city>
        <zip>59208</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Muenchen</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bochum</city>
        <state>Nordrhein-Westfalen</state>
        <zip>44787</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Koeln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50674</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Almada</city>
        <zip>2801-951</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aveiro</city>
        <zip>3814-501</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kazan</city>
        <zip>420061</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>191167</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Samara</city>
        <zip>443029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Smolensk</city>
        <zip>214006</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>190103</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2113</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wentworth</city>
        <state>KwaZulu- Natal</state>
        <zip>4052</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Observatory, Cape Town</city>
        <zip>7925</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vosloorus Ext 2</city>
        <zip>1475</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Badalona, Barcelona</city>
        <zip>8916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>La Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Marbella</city>
        <zip>29600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Murcia</city>
        <zip>30003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zuerich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>January 16, 2023</last_update_submitted>
  <last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV infection</keyword>
  <keyword>GSK3640254</keyword>
  <keyword>Nucleoside Reverse Transcriptase Inhibitor</keyword>
  <keyword>Dolutegravir</keyword>
  <keyword>Abacavir (ABC)/Lamivudine (3TC)</keyword>
  <keyword>Emtricitabine (FTC)/tenofovir alafenamide (TAF)</keyword>
  <keyword>Maturation Inhibitor</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>Dolutegravir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</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>IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>http://clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>September 5, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493216
org study id: 208379
nct id: NCT04493216
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254
      doses [100, 150 and 200 milligrams {mg}]), active controlled clinical trial. It will aim to
      investigate the safety, efficacy and dose-response of GSK3640254 compared to dolutegravir
      (DTG), each given in combination with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
      (abacavir/lamivudine [ABC/3TC] or emtricitabine/tenofovir alafenamide [FTC/TAF])
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized, multicenter, parallel group study.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The study treatment assignments will not be blinded (GSK3640254 versus Dolutegravir control arm). However, the dose level of GSK3640254 in each of the treatment arms containing GSK3640254 will be blinded to the research participants and all study personnel during the study. The Sponsor personnel will also remain blinded until the database lock for the Week 24 analysis.
measure: Proportion of participants with plasma HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL) at Week 24
time frame: At Week 24
measure: Proportion of participants with plasma HIV-1 RNA <50 c/mL at Weeks 48 and 96
time frame: At Weeks 48 and 96
measure: Absolute values of HIV-1 RNA at Weeks 24, 48 and 96
time frame: At Weeks 24, 48 and 96
measure: Change from Baseline in plasma HIV-1 RNA at Weeks 24, 48 and 96 (c/mL)
time frame: Baseline and at Weeks 24, 48 and 96
measure: Absolute values of Cluster of differentiation 4 plus (CD4+) cell counts at Weeks 24, 48 and 96
time frame: At Weeks 24, 48 and 96
measure: Change from Baseline in CD4+ cell counts at Weeks 24, 48 and 96 (Cells per cubic millimeters [cells/mm^3])
time frame: Baseline and at Weeks 24, 48 and 96
measure: Number of participants with Adverse events (AEs), serious adverse events (SAEs), Deaths and adverse events (AEs) leading to treatment discontinuation at Weeks 24, 48 and 96
time frame: At Weeks 24, 48 and 96
measure: Severity of AEs at Weeks 24, 48 and 96
time frame: At Weeks 24, 48 and 96
measure: Number of participants who develop phenotypic and genotypic resistance resistance at Weeks 24, 48 and 96
time frame: At Weeks 24, 48 and 96
measure: Maximum observed concentration (Cmax) of GSK3640254 at steady state at Weeks 24 and 48
time frame: At Weeks 24 and 48
measure: AUC over the dosing interval (AUC [0-tau]) of GSK3640254 at Weeks 24 and 48
time frame: At Weeks 24 and 48
measure: Plasma concentration at the end of the dosing (Ctau) of GSK3640254 at steady state at Weeks 24 and 48
time frame: At Weeks 24 and 48
arm group label: Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
arm group type: Experimental
arm group label: Blinded GSK3640254 150 mg + Open Label ABC/3TC or FTC/TAF
arm group type: Experimental
arm group label: Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
arm group type: Experimental
arm group label: Open Label DTG + Open Label ABC/3TC or FTC/TAF
arm group type: Active Comparator
intervention type: Drug
intervention name: GSK3640254
description: GSK3640254 will be available as a 25 mg and 100 mg tablets to be administered via oral route.
arm group label: Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
arm group label: Blinded GSK3640254 150 mg + Open Label ABC/3TC or FTC/TAF
arm group label: Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
intervention type: Drug
intervention name: ABC/3TC
description: ABC/3TC will be available as abacavir 600 mg/lamivudine 300 mg tablet to be administered via oral route.
arm group label: Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
arm group label: Blinded GSK3640254 150 mg + Open Label ABC/3TC or FTC/TAF
arm group label: Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
arm group label: Open Label DTG + Open Label ABC/3TC or FTC/TAF
intervention type: Drug
intervention name: FTC/TAF
description: FTC/TAF will be available as emtricitabine 200 mg/tenofovir alafenamide 25 mg tablet to be administered via oral route.
arm group label: Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
arm group label: Blinded GSK3640254 150 mg + Open Label ABC/3TC or FTC/TAF
arm group label: Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
arm group label: Open Label DTG + Open Label ABC/3TC or FTC/TAF
intervention type: Drug
intervention name: Dolutegravir
description: Dolutegravir will be available as a 50 mg tablet to be administered via oral route.
arm group label: Open Label DTG + Open Label ABC/3TC or FTC/TAF
intervention type: Drug
intervention name: Placebo
description: Placebo matching GSK3640254 will be administered in the form of tablets via oral route.
arm group label: Blinded GSK3640254 100 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
arm group label: Blinded GSK3640254 200 mg + GSK3640254 matching placebo + Open Label ABC/3TC or FTC/TAF
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: ViiV Healthcare
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country: Argentina
country: Canada
country: France
country: Germany
country: Italy
country: Portugal
country: Russian Federation
country: South Africa
country: Spain
country: Switzerland
country: United States
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Dolutegravir
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
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: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
ipd url: http://clinicalstudydatarequest.com
submitted: September 5, 2023