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/NCT05979311</url>
    </required_header>
    <id_info>
      <org_study_id>219816</org_study_id>
      <nct_id>NCT05979311</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy</brief_title>
    <acronym>VOGUE</acronym>
    <official_title>A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofovir Alafenamide Once Daily for Virologic Suppression and Maintenance in Antiretroviral Therapy Naive 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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will compare safety, efficacy, participant reported outcomes and implementation&#xD;
        outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus&#xD;
        lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and&#xD;
        tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously&#xD;
        received antiretroviral therapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 17, 2023</start_date>
    <completion_date type="Anticipated">July 13, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 11, 2025</primary_completion_date>
    <phase>Phase 3</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>Percentage of participants with plasma HIV- Ribonucleic acid (RNA) less than (&lt;)50 copies per milliliter (c/mL) as per snapshot algorithm at Week 48</measure>
      <time_frame>Week 48</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with plasma HIV-1 RNA &lt;50 c/mL as per snapshot algorithm at Weeks 24 and 96</measure>
      <time_frame>Weeks 24 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with HIV-RNA greater than or equal to (&gt;=)50 c/mL as per snapshot algorithm at Weeks 24, 48, and 96</measure>
      <time_frame>Weeks 24, 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in HIV-1 RNA at Weeks 24, 48 and 96</measure>
      <time_frame>Baseline (Day 1) and Weeks 24, 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Cluster of differentiation 4 positive (CD4+) cell count at Weeks 24, 48 and 96</measure>
      <time_frame>Baseline (Day 1) and Weeks 24, 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in CD4/Cluster of differentiation 8 (CD8) at Weeks 24, 48 and 96</measure>
      <time_frame>Baseline (Day 1) and Weeks 24, 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With HIV-1 Disease Progression</measure>
      <time_frame>Weeks 24, 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to virologic suppression (HIV-1 RNA &lt;50 c/mL) from Baseline</measure>
      <time_frame>Baseline (Day 1) and Up to Week 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with confirmed virologic withdrawal (CVW)</measure>
      <time_frame>Up to Week 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with treatment-emergent resistance</measure>
      <time_frame>Up to week 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Renal Biomarkers- estimated glomerular filtration rate at Weeks 48 and 96</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Renal Biomarkers- urinary protein/creatinine at Weeks 48 and 96</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in renal biomarker- Serum Cystatin C at Weeks 48 and 96 (Milligrams per liter)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in renal biomarker- Serum Retinol Binding Protein (RBP) at Weeks 48 and 96 (Milligrams per deciliter)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in renal biomarker- Serum Beta-2 Microglobulin (B2M) at Weeks 48 and 96 (Micrograms per milliliter)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in bone biomarkers- Serum Bone Specific Alkaline Phosphatase, Serum Procollagen type 1 N- Propeptide, Serum Type I Collagen C-Telopeptides and Serum Osteocalcin at Weeks 48 and 96 (Micrograms per Liter)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in bone biomarkers- Serum Vitamin D at Weeks 48 and 96 (Nanomoles per Liter)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline (Week 4) in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction status Questionnaire (HIVTSQs) at Weeks 12, 24, 48 and 96 (Scores on a scale)</measure>
      <time_frame>Baseline (Week 4) and Weeks 12, 24, 48 and 96</time_frame>
      <description>The HIVTSQ status version (HIVTSQs) is assessing participants' satisfaction with their current treatment with a Total score ranging from 0 to 60. Higher scores indicate a greater level of satisfaction with HIV treatment. Baseline is defined as measurement value at Week 4.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline (Week 4) in Individual Item Scores Using HIVTSQs at Weeks12, 24, 48 and 96 (Scores on a scale)</measure>
      <time_frame>Baseline (Week 4) and Weeks 12, 24, 48 and 96</time_frame>
      <description>Individual items scores range from 0 to 6 (0=very dissatisfied, 6=very satisfied). Baseline is defined as measurement value at Week 4.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline (Week 4) in Domains Scores Using HIVTSQs at Weeks 12, 24, 48 and 96 (Scores on a scale)</measure>
      <time_frame>Baseline (Week 4) and Weeks 12, 24, 48 and 96</time_frame>
      <description>There are two domain scores of General Satisfaction/Clinical and Lifestyle/Ease subscales; each comprised of 5 items with possible scores of 0 to 30. The higher the score, the greater the satisfaction within the subscale. Baseline is defined as measurement value at Week 4.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in bothersome symptoms using the Symptom Distress Module at Weeks 4, 12, 24, 48 and 96 (Score on a scale)</measure>
      <time_frame>Baseline (Day 1) and Weeks 4, 12, 24, 48 and 96</time_frame>
      <description>The Symptom Distress Module (SDM) is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom bother score is based on the score for each symptom present ranging from 1 (it does not bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute values for waist and hip circumference (Centimeters)</measure>
      <time_frame>Up to Week 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute values for waist to hip ratio and waist to height ratio (Ratio)</measure>
      <time_frame>Up to Week 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute values for Body weight (Kilogram)</measure>
      <time_frame>Up to Week 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute values for systolic and diastolic blood pressure (millimeters of mercury)</measure>
      <time_frame>Up to Week 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Body Mass Index (kilogram per square meter)</measure>
      <time_frame>Baseline (Day 1) and Up to Week 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in body weight greater than (&gt;) 5 percentage (%) at Weeks 24, 48 and 96</measure>
      <time_frame>Baseline (Day 1) and Weeks 24, 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in total and regional (trunk and extremities) fat assessed by Dual-energy X-ray absorptiometry (DXA) at Weeks 48 and 96</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in total and regional (trunk and extremities) fat-free mass assessed by DXA Weeks 48 and 96</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in lumbar and hip bone mineral density (BMD) assessed by DXA at Weeks 48 and 96</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in trabecular bone score (TBS) assessed by DXA at Weeks 48 and 96</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
      <description>Trabecular bone score (TBS) is a lumbar spine dual-energy absorptiometry texture index, which provides information on microarchitecture skeletal quality partially independent of BMD.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in fasting glucose (Millimoles per Liter)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in insulin (Microunits per millilliter)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 48 and Week 96</measure>
      <time_frame>Baseline (Day 1), Week 48 and Week 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Hemoglobin A1c [HbA1c] at Week 48 and Week 96 (Percentage of HbA1c)</measure>
      <time_frame>Baseline (Day 1), Week 48 and Week 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in plasma lipids (total, high-density lipoprotein [HDL], and low-density lipoprotein [LDL] cholesterol, triglycerides) (Millimoles per Liter) at Week 48 and Week 96</measure>
      <time_frame>Baseline (Day 1), Week 48 and Week 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in QDiabetes Score at Week 48 and Week 96 (Scores on a scale)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
      <description>QDiabetes score defines the risk (percentage) of developing type 2 Diabetes in the next ten years. The score ranges from 0-100.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Fibrosis 4 (FIB-4) Score at Week 48 and Week 96 (Scores on a scale)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
      <description>A value of FIB-4 scores below 1.30 is considered as low risk for advanced fibrosis; value of FIB-4 over 2.67 is considered as high risk for advanced fibrosis; and FIB-4 values between 1.30 and 2.67 are considered as intermediate risk of advanced fibrosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with metabolic syndrome at Weeks 48 and 96</measure>
      <time_frame>Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Framingham cardiovascular risk scores at Weeks 48 and 96 (Scores on a scale)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
      <description>Coronary heart disease (CHD) risk at 10 years in percent (%) can be calculated with the help of the Framingham Risk Score. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Data collection on Adverse events of anti-HIV Drugs (DAD) cardiovascular risk scores at Weeks 48 and 96 (Scores on a scale)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
      <description>Coronary heart disease (CHD) risk at 5 years in percent can be calculated with the help of the DAD Risk Score. The 5-year risk of CHD is classified as low (&lt;1%), moderate (1 to 5%), high (5 to 10%), or very high (&gt;10%).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes from Baseline in Systolic and diastolic blood pressure at Weeks 48 and 96 millimeters of mercury (mmHg)</measure>
      <time_frame>Baseline (Day 1), Weeks 48 and 96</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">412</enrollment>
    <condition>HIV</condition>
    <condition>HIV Infections</condition>
    <arm_group>
      <arm_group_label>DTG/3TC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive FDC of DTG/3TC once daily until Week 96.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BIC/FTC/TAF</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive BIC/FTC/TAF once daily until Week 96.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dolutegravir</intervention_name>
      <description>Dolutegravir will be administered once daily.</description>
      <arm_group_label>DTG/3TC</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lamivudine</intervention_name>
      <description>Lamivudine will be administered once daily.</description>
      <arm_group_label>DTG/3TC</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bictegravir</intervention_name>
      <description>Bictegravir will be administered once daily.</description>
      <arm_group_label>BIC/FTC/TAF</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Emtricitabine</intervention_name>
      <description>Emtricitabine will be administered once daily.</description>
      <arm_group_label>BIC/FTC/TAF</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tenofovir alafenamide</intervention_name>
      <description>Tenofovir alafenamide will be administered once daily.</description>
      <arm_group_label>BIC/FTC/TAF</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants with age &gt;=18 years (or older, if required by local regulations) at the&#xD;
               time of obtaining informed consent.&#xD;
  &#xD;
            -  An individual participant is eligible to participate if they are not pregnant (as&#xD;
               confirmed by a negative serum human chorionic gonadotropin (hCG) test at Screening and&#xD;
               a negative urine hCG test at Enrollment) and not lactating.&#xD;
  &#xD;
            -  Antiretroviral-naïve (no prior therapy with any antiretroviral agent following a&#xD;
               diagnosis of HIV-1 infection) person living with HIV.&#xD;
  &#xD;
            -  Participant (or participant's legally acceptable representative [LAR]) is capable of&#xD;
               giving written informed consent.&#xD;
  &#xD;
            -  Eligible participants or their LAR must sign a written Informed Consent Form before&#xD;
               any protocol-specified assessments are conducted. Enrollment of participants who are&#xD;
               unable to provide direct informed consent is optional and will be based on local&#xD;
               legal/regulatory requirements and site feasibility to conduct protocol procedures.&#xD;
  &#xD;
            -  Participants enrolled in France must be affiliated to, or a beneficiary of, a social&#xD;
               security category.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals who are pregnant or breastfeeding or plan to become pregnant or breastfeed&#xD;
               during the study.&#xD;
  &#xD;
            -  Any evidence of a current Centers for Disease Control and Prevention (CDC) Stage 3&#xD;
               disease; with the exception of cutaneous Kaposi's sarcoma not requiring systemic&#xD;
               therapy, and CD4+ count &lt;200 cells per cubic millimeter (neither is exclusionary).&#xD;
  &#xD;
            -  History or presence of allergy or intolerance to the study drugs or their components&#xD;
               or drugs of their class, or a history of drug or other allergy that, in the opinion of&#xD;
               the Investigator or Medical Monitor, contraindicates study participation.&#xD;
  &#xD;
            -  Ongoing or clinically relevant pancreatitis.&#xD;
  &#xD;
            -  Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or&#xD;
               resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial&#xD;
               neoplasia; other localized malignancies require agreement between the Investigator and&#xD;
               the Medical Monitor for inclusion of the participant prior to enrollment.&#xD;
  &#xD;
            -  Participants with severe hepatic impairment (Class C) as determined by Child-Pugh&#xD;
               classification.&#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 liver cirrhosis with or without hepatitis viral co-infection.&#xD;
  &#xD;
            -  Alanine aminotransferase (ALT) &gt;=5 times the upper limit of normal (ULN) or ALT&#xD;
               &gt;=3*ULN and bilirubin &gt;=1.5*ULN (with &gt;35% direct bilirubin).&#xD;
  &#xD;
            -  Participants determined by the Investigator to have a high risk of seizures, including&#xD;
               participants with an unstable or poorly controlled seizure disorder. A participant&#xD;
               with a prior history of seizure may be considered for enrollment if the Investigator&#xD;
               believes the risk of seizure recurrence is low. All cases of prior seizure history&#xD;
               should be discussed with the Medical Monitor prior to enrollment.&#xD;
  &#xD;
            -  Participants who, in the investigator's judgment, pose a significant suicide risk.&#xD;
               Participant's recent history of suicidal behavior and/or suicidal ideation should be&#xD;
               considered when evaluating for suicide risk.&#xD;
  &#xD;
            -  Signs and symptoms which, in the opinion of the Investigator, are suggestive of active&#xD;
               Coronavirus disease 2019 (COVID-19) (example fever, cough) infection within 14 days&#xD;
               prior to enrollment.&#xD;
  &#xD;
            -  Evidence of Hepatitis B virus (HBV) infection based on the results of central lab&#xD;
               testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core&#xD;
               antibody (HBcAb), Hepatitis B surface antibody (HBsAb) and HBV Deoxyribonucleic Acid&#xD;
               (DNA) as follows:&#xD;
  &#xD;
               a. Participants positive for HBsAg are excluded; b. Participants negative for HBsAb&#xD;
               and negative for HBsAg but positive for hepatitis B core antibody (HBcAb) may be&#xD;
               excluded based on the following consideration: i. Exclude if HBV DNA is detected&#xD;
               [either &lt;Lower Limit of Quantification (LLoQ), &gt;Upper Limit of Quantification (ULoQ)&#xD;
               OR numerical value (i.e., between LLoQ and ULoQ)] ii. Not excluded if HBV DNA is&#xD;
               negative, not detected&#xD;
  &#xD;
            -  Participants with Hepatitis C virus (HCV) co-infection at Screening are eligible only&#xD;
               if:&#xD;
  &#xD;
               i. liver enzymes meet entry criteria; and ii. HCV disease is not anticipated to&#xD;
               require on-study treatment with any agent(s) that have potential adverse drug-drug&#xD;
               interactions (DDIs) with the study interventions; and iii. HCV disease has undergone&#xD;
               appropriate work-up and is not advanced and will not require treatment prior to the&#xD;
               primary endpoint or later visit. Additional information on participants with HCV&#xD;
               co-infection at screening should include results from any liver biopsy, Fibroscan,&#xD;
               ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated&#xD;
               liver disease, prior treatment, and timing/plan for HCV treatment.&#xD;
  &#xD;
          iv. In the event that recent biopsy or imaging data is not available or inconclusive, the&#xD;
          Fib-4 score will be used to verify eligibility&#xD;
  &#xD;
            1. Fib-4 score &gt;3.25 is exclusionary;&#xD;
  &#xD;
            2. Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation.&#xD;
  &#xD;
          Fibrosis 4 score Formula:&#xD;
  &#xD;
          (Age * Aspartate aminotransferase [AST]) / (Platelets * (square root of ALT)&#xD;
  &#xD;
            -  Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without&#xD;
               clear documentation of treatment) are excluded. Participants with a false positive RPR&#xD;
               (with negative treponemal test) or serofast RPR result (persistence of a reactive&#xD;
               nontreponemal syphilis test despite history of adequate therapy and no evidence of&#xD;
               re-exposure) may enroll after consultation with the Medical Monitor. Participants who&#xD;
               completed treatment at least 7 days prior to Screening are eligible.&#xD;
  &#xD;
            -  Presence of any major resistance-associated mutations as defined by the International&#xD;
               Antiviral Society-United States of America (IAS-USA) resistance guidelines to DTG,&#xD;
               3TC, BIC, FTC or TAF in the Screening result.&#xD;
  &#xD;
            -  Exposure to an experimental drug or experimental vaccine within either 30 days, 5&#xD;
               half-lives of the test agent, or twice the duration of the biological effect of the&#xD;
               test agent (whichever is longer), prior to first dose of study treatment.&#xD;
  &#xD;
            -  Treatment with any of the following agents within 28 days of Screening:&#xD;
  &#xD;
               i. radiation therapy; ii. cytotoxic chemotherapeutic agents; iii. tuberculosis therapy&#xD;
               with the exception of isoniazid (isonicotinylhydrazid, INH); iv. immunomodulators that&#xD;
               alter immune responses such as chronic systemic corticosteroids, interleukins, or&#xD;
               interferons.&#xD;
  &#xD;
            -  Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.&#xD;
  &#xD;
            -  Treatment with any agent with documented activity against HIV-1 in vitro within 28&#xD;
               days of first dose of study treatment. Treatment withacyclovir/valacyclovir is&#xD;
               permitted.&#xD;
  &#xD;
            -  Participants receiving any protocol-defined prohibited medication and who are&#xD;
               unwilling or unable to switch to an alternate medication.&#xD;
  &#xD;
            -  Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid&#xD;
               abnormalities.&#xD;
  &#xD;
            -  Any acute laboratory abnormality at Screening, which, in the opinion of the&#xD;
               investigator, would preclude the participant's participation in an interventional&#xD;
               clinical trial.&#xD;
  &#xD;
            -  Participant has estimated creatine clearance &lt;30 milliliter per minute (mL/min) per&#xD;
               1.73 square meter using the refitted, race-neutral Chronic Kidney Disease Epidemiology&#xD;
               Collaboration (CKD-EPIcr_R) method.&#xD;
  &#xD;
            -  Participants known or suspected to have acquired HIV-1 concurrent with use of&#xD;
               Pre-exposure prophylaxis (PrEP) or Post-exposure prophylaxis (PEP) must be discussed&#xD;
               with the Medical Monitor prior to enrollment.&#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 or render the&#xD;
               participant unable to receive study medication.&#xD;
  &#xD;
            -  Any pre-existing physical or mental condition (including substance use disorder)&#xD;
               which, in the opinion of the Investigator, may interfere with the participant's&#xD;
               ability to comply with the dosing schedule and/or protocol evaluations or which may&#xD;
               compromise the safety of the participant.&#xD;
  &#xD;
            -  Participant is currently participating in, or anticipates being selected for, any&#xD;
               other interventional study.&#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_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>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Antiretroviral-naïve</keyword>
    <keyword>Bictegravir</keyword>
    <keyword>Dolutegravir</keyword>
    <keyword>Emtricitabine</keyword>
    <keyword>Human immunodeficiency virus 1 (HIV-1)</keyword>
    <keyword>Lamivudine</keyword>
    <keyword>Virologic suppression</keyword>
    <keyword>Tenofovir alafenamide</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>Tenofovir</mesh_term>
      <mesh_term>Lamivudine</mesh_term>
      <mesh_term>Emtricitabine</mesh_term>
      <mesh_term>Dolutegravir</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/NCT05979311
  org study id: 219816
  nct id: NCT05979311
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study will compare safety, efficacy, participant reported outcomes and implementation
        outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus
        lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and
        tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously
        received antiretroviral therapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percentage of participants with plasma HIV- Ribonucleic acid (RNA) less than (<)50 copies per milliliter (c/mL) as per snapshot algorithm at Week 48
  time frame: Week 48
  measure: Percentage of participants with plasma HIV-1 RNA <50 c/mL as per snapshot algorithm at Weeks 24 and 96
  time frame: Weeks 24 and 96
  measure: Percentage of participants with HIV-RNA greater than or equal to (>=)50 c/mL as per snapshot algorithm at Weeks 24, 48, and 96
  time frame: Weeks 24, 48 and 96
  measure: Change from Baseline in HIV-1 RNA at Weeks 24, 48 and 96
  time frame: Baseline (Day 1) and Weeks 24, 48 and 96
  measure: Change from Baseline in Cluster of differentiation 4 positive (CD4+) cell count at Weeks 24, 48 and 96
  time frame: Baseline (Day 1) and Weeks 24, 48 and 96
  measure: Change from Baseline in CD4/Cluster of differentiation 8 (CD8) at Weeks 24, 48 and 96
  time frame: Baseline (Day 1) and Weeks 24, 48 and 96
  measure: Number of Participants With HIV-1 Disease Progression
  time frame: Weeks 24, 48 and 96
  measure: Time to virologic suppression (HIV-1 RNA <50 c/mL) from Baseline
  time frame: Baseline (Day 1) and Up to Week 96
  measure: Number of participants with confirmed virologic withdrawal (CVW)
  time frame: Up to Week 96
  measure: Number of Participants with treatment-emergent resistance
  time frame: Up to week 96
  measure: Change from Baseline in Renal Biomarkers- estimated glomerular filtration rate at Weeks 48 and 96
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline in Renal Biomarkers- urinary protein/creatinine at Weeks 48 and 96
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline in renal biomarker- Serum Cystatin C at Weeks 48 and 96 (Milligrams per liter)
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline in renal biomarker- Serum Retinol Binding Protein (RBP) at Weeks 48 and 96 (Milligrams per deciliter)
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline in renal biomarker- Serum Beta-2 Microglobulin (B2M) at Weeks 48 and 96 (Micrograms per milliliter)
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline in bone biomarkers- Serum Bone Specific Alkaline Phosphatase, Serum Procollagen type 1 N- Propeptide, Serum Type I Collagen C-Telopeptides and Serum Osteocalcin at Weeks 48 and 96 (Micrograms per Liter)
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline in bone biomarkers- Serum Vitamin D at Weeks 48 and 96 (Nanomoles per Liter)
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline (Week 4) in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction status Questionnaire (HIVTSQs) at Weeks 12, 24, 48 and 96 (Scores on a scale)
  time frame: Baseline (Week 4) and Weeks 12, 24, 48 and 96
  description: The HIVTSQ status version (HIVTSQs) is assessing participants' satisfaction with their current treatment with a Total score ranging from 0 to 60. Higher scores indicate a greater level of satisfaction with HIV treatment. Baseline is defined as measurement value at Week 4.
  measure: Change from Baseline (Week 4) in Individual Item Scores Using HIVTSQs at Weeks12, 24, 48 and 96 (Scores on a scale)
  time frame: Baseline (Week 4) and Weeks 12, 24, 48 and 96
  description: Individual items scores range from 0 to 6 (0=very dissatisfied, 6=very satisfied). Baseline is defined as measurement value at Week 4.
  measure: Change from Baseline (Week 4) in Domains Scores Using HIVTSQs at Weeks 12, 24, 48 and 96 (Scores on a scale)
  time frame: Baseline (Week 4) and Weeks 12, 24, 48 and 96
  description: There are two domain scores of General Satisfaction/Clinical and Lifestyle/Ease subscales; each comprised of 5 items with possible scores of 0 to 30. The higher the score, the greater the satisfaction within the subscale. Baseline is defined as measurement value at Week 4.
  measure: Change from Baseline in bothersome symptoms using the Symptom Distress Module at Weeks 4, 12, 24, 48 and 96 (Score on a scale)
  time frame: Baseline (Day 1) and Weeks 4, 12, 24, 48 and 96
  description: The Symptom Distress Module (SDM) is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom bother score is based on the score for each symptom present ranging from 1 (it does not bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score).
  measure: Absolute values for waist and hip circumference (Centimeters)
  time frame: Up to Week 96
  measure: Absolute values for waist to hip ratio and waist to height ratio (Ratio)
  time frame: Up to Week 96
  measure: Absolute values for Body weight (Kilogram)
  time frame: Up to Week 96
  measure: Absolute values for systolic and diastolic blood pressure (millimeters of mercury)
  time frame: Up to Week 96
  measure: Change from Baseline in Body Mass Index (kilogram per square meter)
  time frame: Baseline (Day 1) and Up to Week 96
  measure: Change from Baseline in body weight greater than (>) 5 percentage (%) at Weeks 24, 48 and 96
  time frame: Baseline (Day 1) and Weeks 24, 48 and 96
  measure: Change from Baseline in total and regional (trunk and extremities) fat assessed by Dual-energy X-ray absorptiometry (DXA) at Weeks 48 and 96
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline in total and regional (trunk and extremities) fat-free mass assessed by DXA Weeks 48 and 96
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline in lumbar and hip bone mineral density (BMD) assessed by DXA at Weeks 48 and 96
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline in trabecular bone score (TBS) assessed by DXA at Weeks 48 and 96
  time frame: Baseline (Day 1), Weeks 48 and 96
  description: Trabecular bone score (TBS) is a lumbar spine dual-energy absorptiometry texture index, which provides information on microarchitecture skeletal quality partially independent of BMD.
  measure: Change from Baseline in fasting glucose (Millimoles per Liter)
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline in insulin (Microunits per millilliter)
  time frame: Baseline (Day 1), Weeks 48 and 96
  measure: Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 48 and Week 96
  time frame: Baseline (Day 1), Week 48 and Week 96
  measure: Change from Baseline in Hemoglobin A1c [HbA1c] at Week 48 and Week 96 (Percentage of HbA1c)
  time frame: Baseline (Day 1), Week 48 and Week 96
  measure: Change from Baseline in plasma lipids (total, high-density lipoprotein [HDL], and low-density lipoprotein [LDL] cholesterol, triglycerides) (Millimoles per Liter) at Week 48 and Week 96
  time frame: Baseline (Day 1), Week 48 and Week 96
  measure: Change from Baseline in QDiabetes Score at Week 48 and Week 96 (Scores on a scale)
  time frame: Baseline (Day 1), Weeks 48 and 96
  description: QDiabetes score defines the risk (percentage) of developing type 2 Diabetes in the next ten years. The score ranges from 0-100.
  measure: Change from Baseline in Fibrosis 4 (FIB-4) Score at Week 48 and Week 96 (Scores on a scale)
  time frame: Baseline (Day 1), Weeks 48 and 96
  description: A value of FIB-4 scores below 1.30 is considered as low risk for advanced fibrosis; value of FIB-4 over 2.67 is considered as high risk for advanced fibrosis; and FIB-4 values between 1.30 and 2.67 are considered as intermediate risk of advanced fibrosis.
  measure: Number of participants with metabolic syndrome at Weeks 48 and 96
  time frame: Weeks 48 and 96
  measure: Change from Baseline in Framingham cardiovascular risk scores at Weeks 48 and 96 (Scores on a scale)
  time frame: Baseline (Day 1), Weeks 48 and 96
  description: Coronary heart disease (CHD) risk at 10 years in percent (%) can be calculated with the help of the Framingham Risk Score. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.
  measure: Change from Baseline in Data collection on Adverse events of anti-HIV Drugs (DAD) cardiovascular risk scores at Weeks 48 and 96 (Scores on a scale)
  time frame: Baseline (Day 1), Weeks 48 and 96
  description: Coronary heart disease (CHD) risk at 5 years in percent can be calculated with the help of the DAD Risk Score. The 5-year risk of CHD is classified as low (<1%), moderate (1 to 5%), high (5 to 10%), or very high (>10%).
  measure: Changes from Baseline in Systolic and diastolic blood pressure at Weeks 48 and 96 millimeters of mercury (mmHg)
  time frame: Baseline (Day 1), Weeks 48 and 96
  arm group label: DTG/3TC
  arm group type: Experimental
  description: Participants will receive FDC of DTG/3TC once daily until Week 96.
  arm group label: BIC/FTC/TAF
  arm group type: Active Comparator
  description: Participants will receive BIC/FTC/TAF once daily until Week 96.
  intervention type: Drug
  intervention name: Dolutegravir
  description: Dolutegravir will be administered once daily.
  arm group label: DTG/3TC
  intervention type: Drug
  intervention name: Lamivudine
  description: Lamivudine will be administered once daily.
  arm group label: DTG/3TC
  intervention type: Drug
  intervention name: Bictegravir
  description: Bictegravir will be administered once daily.
  arm group label: BIC/FTC/TAF
  intervention type: Drug
  intervention name: Emtricitabine
  description: Emtricitabine will be administered once daily.
  arm group label: BIC/FTC/TAF
  intervention type: Drug
  intervention name: Tenofovir alafenamide
  description: Tenofovir alafenamide will be administered once daily.
  arm group label: BIC/FTC/TAF
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  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
  responsible party type: Sponsor
  mesh term: HIV Infections
  mesh term: Tenofovir
  mesh term: Lamivudine
  mesh term: Emtricitabine
  mesh term: Dolutegravir
  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/