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/NCT06039579</url>
    </required_header>
    <id_info>
      <org_study_id>218307</org_study_id>
      <secondary_id>2023-505350-18-00</secondary_id>
      <nct_id>NCT06039579</nct_id>
    </id_info>
    <brief_title>Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults</brief_title>
    <acronym>CINNAMON</acronym>
    <official_title>A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Phase 2a Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Orally Administered Investigational Capsid Inhibitor Monotherapy in HIV-1 Infected Treatment-Naïve 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>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary purpose of the study is to evaluate the antiviral activity of orally administered&#xD;
        VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1)&#xD;
        infected Treatment-Naïve (TN) participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">March 25, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 25, 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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum Change from Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA)</measure>
      <time_frame>Baseline (Day 1) and up to Day 11</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Adverse Events (AE) as per Severity and AEs Leading to Study Treatment Discontinuation</measure>
      <time_frame>Up to Day 39</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline for Liver Panel Laboratory Parameters: Total Bilirubin and Direct Bilirubin (Micromoles per Liter [umol/L])</measure>
      <time_frame>Baseline (Day 1) and up to Day 39</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT) Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) (International Units per Liter)</measure>
      <time_frame>Baseline (Day 1) and up to Day 39</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Maximum Toxicity Grade from Baseline for Liver Panel Laboratory Parameters: Total Bilirubin and Direct Bilirubin (umol/L)</measure>
      <time_frame>Baseline (Day 1) and up to Day 39</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Maximum Toxicity Grade from Baseline for Liver Panel Laboratory Parameters: ALT, ALP, and AST (International Units per Liter)</measure>
      <time_frame>Baseline (Day 1) and up to Day 39</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum Observed Plasma Drug Concentration (Cmax) for VH4004280</measure>
      <time_frame>Up to Day 39</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum Observed Plasma Drug Concentration (Cmax) for VH4011499</measure>
      <time_frame>Up to Day 39</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Maximum Observed Plasma Drug Concentration (tmax) for VH4004280 (Hours)</measure>
      <time_frame>Up to Day 39</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Maximum Observed Plasma Drug Concentration (tmax) for VH4011499 (Hours)</measure>
      <time_frame>Up to Day 39</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma Concentrations of VH4004280</measure>
      <time_frame>At Day 11</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma Concentrations of VH4011499</measure>
      <time_frame>At Day 11</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4004280 (copies per milliliter)</measure>
      <time_frame>Baseline (Day 1) and up to Day 11</time_frame>
      <description>Plasma samples will be collected for quantitative analysis of HIV-1 RNA.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4011499 (copies per milliliter)</measure>
      <time_frame>Baseline (Day 1) and up to Day 11</time_frame>
      <description>Plasma samples will be collected for quantitative analysis of HIV-1 RNA</description>
    </secondary_outcome>
    <number_of_arms>10</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>HIV Infections</condition>
    <arm_group>
      <arm_group_label>Part 1a - Participants Receiving VH4004280 Dose 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1a - Participants Receiving VH4004280 Dose 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1a - Participants Receiving VH4004280 Matching Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1b - Participants Receiving VH4011499 Dose 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1b - Participants Receiving VH4011499 Dose 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1b - Participants Receiving VH4011499 Matching Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2a - Participants Receiving VH4004280 Dose 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2a - Participants Receiving VH4004280 Matching Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2b - Participants Receiving VH4011499 Dose 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2b - Participants Receiving VH4011499 Matching Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VH4004280</intervention_name>
      <description>VH4004280 will be administered.</description>
      <arm_group_label>Part 1a - Participants Receiving VH4004280 Dose 1</arm_group_label>
      <arm_group_label>Part 1a - Participants Receiving VH4004280 Dose 2</arm_group_label>
      <arm_group_label>Part 2a - Participants Receiving VH4004280 Dose 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VH4011499</intervention_name>
      <description>VH4011499 will be administered.</description>
      <arm_group_label>Part 1b - Participants Receiving VH4011499 Dose 1</arm_group_label>
      <arm_group_label>Part 1b - Participants Receiving VH4011499 Dose 2</arm_group_label>
      <arm_group_label>Part 2b - Participants Receiving VH4011499 Dose 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VH4004280 Matching Placebo</intervention_name>
      <description>VH4004280 matching placebo will be administered.</description>
      <arm_group_label>Part 1a - Participants Receiving VH4004280 Matching Placebo</arm_group_label>
      <arm_group_label>Part 2a - Participants Receiving VH4004280 Matching Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VH4011499 Matching Placebo</intervention_name>
      <description>VH4011499 matching placebo will be administered.</description>
      <arm_group_label>Part 1b - Participants Receiving VH4011499 Matching Placebo</arm_group_label>
      <arm_group_label>Part 2b - Participants Receiving VH4011499 Matching Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants who are overtly healthy (other than HIV-1 infection).&#xD;
  &#xD;
            -  Screening cluster of differentiation-4 (CD4+) T-cell count greater than or equal to&#xD;
               (≥)200 cells/microliter (µL).&#xD;
  &#xD;
            -  Documented HIV-1 infection and Screening plasma HIV-1 RNA ≥3000 copies/milliliter&#xD;
               (mL).&#xD;
  &#xD;
            -  Treatment-naïve: Defined as no antiretroviral therapy received after the diagnosis of&#xD;
               HIV-1 infection. Prior use of oral pre-exposure prophylaxis (PreP) is permitted. Prior&#xD;
               use of parenteral PreP is exclusionary.&#xD;
  &#xD;
            -  Has body mass index (BMI) within the range of 18.5-31.0 kilograms per meter square&#xD;
               (kg/m^2).&#xD;
  &#xD;
            -  Participants male at birth must use male condoms and participants female at birth who&#xD;
               are of childbearing potential must be using acceptable forms of birth control.&#xD;
  &#xD;
            -  Participants capable of giving signed informed consent.&#xD;
  &#xD;
            -  Participant must be willing and able to start locally accessible and commercially&#xD;
               available combination antiretroviral therapy after the monotherapy period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women who are breastfeeding or plan to become pregnant or breast feed during the&#xD;
               study.&#xD;
  &#xD;
            -  Participants with acute HIV infection.&#xD;
  &#xD;
            -  Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3&#xD;
               disease.&#xD;
  &#xD;
            -  Untreated syphilis infection.&#xD;
  &#xD;
            -  Ongoing malignancy other than certain localised malignancies.&#xD;
  &#xD;
            -  Treatment with immunomodulating agents or any agent with known anti-HIV activity.&#xD;
  &#xD;
            -  Has exclusionary psychiatric, hepatic, cardiovascular gastrointestinal, renal&#xD;
               condition.&#xD;
  &#xD;
            -  Participant having any condition which, in the opinion of the investigator, may&#xD;
               interfere with the absorption, distribution, metabolism or excretion of the study&#xD;
               drugs or render the participant unable to take oral medication.&#xD;
  &#xD;
            -  Participants having exclusionary electrocardiogram (ECG) findings.&#xD;
  &#xD;
            -  Participants who have been exposed to any prohibited medication or vaccine.&#xD;
  &#xD;
            -  Participant positive for hepatitis B or hepatitis C.&#xD;
  &#xD;
            -  Participants with exclusionary safety laboratory (e.g Grade 3 or greater abnormality).&#xD;
  &#xD;
            -  Participants who have positive results for illicit drug use, regular use of drugs of&#xD;
               abuse and/or excessive alcohol use.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 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>
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    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Bakersfield</city>
          <state>California</state>
          <zip>93301</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>US GSK Clinical Trials Call Center</last_name>
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        <email>GSKClinicalSupportHD@gsk.com</email>
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    <location>
      <facility>
        <name>GSK Investigational Site</name>
        <address>
          <city>Palm Springs</city>
          <state>California</state>
          <zip>92262</zip>
          <country>United States</country>
        </address>
      </facility>
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        <last_name>US GSK Clinical Trials Call Center</last_name>
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        <email>GSKClinicalSupportHD@gsk.com</email>
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    <location>
      <facility>
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          <city>Pasadena</city>
          <state>California</state>
          <zip>91101</zip>
          <country>United States</country>
        </address>
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        <last_name>US GSK Clinical Trials Call Center</last_name>
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    <location>
      <facility>
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        <address>
          <city>DeLand</city>
          <state>Florida</state>
          <zip>32720</zip>
          <country>United States</country>
        </address>
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          <state>Florida</state>
          <zip>32960</zip>
          <country>United States</country>
        </address>
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          <state>New Jersey</state>
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          <zip>28401</zip>
          <country>United States</country>
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          <state>Tennessee</state>
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          <state>Buenos Aires</state>
          <zip>C1425AGC</zip>
          <country>Argentina</country>
        </address>
      </facility>
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        </address>
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          <country>Canada</country>
        </address>
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          <state>British Columbia</state>
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          <city>Ottawa</city>
          <state>Ontario</state>
          <zip>K1H 8L6</zip>
          <country>Canada</country>
        </address>
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    <location>
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          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5G 2N2</zip>
          <country>Canada</country>
        </address>
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    <location_countries>
      <country>Argentina</country>
      <country>Canada</country>
      <country>France</country>
      <country>Germany</country>
      <country>Italy</country>
      <country>Mexico</country>
      <country>Spain</country>
      <country>United Kingdom</country>
      <country>United States</country>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HIV-1</keyword>
    <keyword>VH4004280</keyword>
    <keyword>VH4011499</keyword>
    <keyword>Treatment Naïve</keyword>
    <keyword>Phase 2a</keyword>
    <keyword>Monotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Infections</mesh_term>
    </condition_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>
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      <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/NCT06039579
  org study id: 218307
  secondary id: 2023-505350-18-00
  nct id: NCT06039579
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The primary purpose of the study is to evaluate the antiviral activity of orally administered
        VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1)
        infected Treatment-Naïve (TN) participants.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Maximum Change from Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA)
  time frame: Baseline (Day 1) and up to Day 11
  measure: Number of Participants with Adverse Events (AE) as per Severity and AEs Leading to Study Treatment Discontinuation
  time frame: Up to Day 39
  measure: Change from Baseline for Liver Panel Laboratory Parameters: Total Bilirubin and Direct Bilirubin (Micromoles per Liter [umol/L])
  time frame: Baseline (Day 1) and up to Day 39
  measure: Change from Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT) Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) (International Units per Liter)
  time frame: Baseline (Day 1) and up to Day 39
  measure: Change in Maximum Toxicity Grade from Baseline for Liver Panel Laboratory Parameters: Total Bilirubin and Direct Bilirubin (umol/L)
  time frame: Baseline (Day 1) and up to Day 39
  measure: Change in Maximum Toxicity Grade from Baseline for Liver Panel Laboratory Parameters: ALT, ALP, and AST (International Units per Liter)
  time frame: Baseline (Day 1) and up to Day 39
  measure: Maximum Observed Plasma Drug Concentration (Cmax) for VH4004280
  time frame: Up to Day 39
  measure: Maximum Observed Plasma Drug Concentration (Cmax) for VH4011499
  time frame: Up to Day 39
  measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for VH4004280 (Hours)
  time frame: Up to Day 39
  measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for VH4011499 (Hours)
  time frame: Up to Day 39
  measure: Plasma Concentrations of VH4004280
  time frame: At Day 11
  measure: Plasma Concentrations of VH4011499
  time frame: At Day 11
  measure: Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4004280 (copies per milliliter)
  time frame: Baseline (Day 1) and up to Day 11
  description: Plasma samples will be collected for quantitative analysis of HIV-1 RNA.
  measure: Change from baseline in plasma HIV-1 RNA relative to concentration on Day 11 (C11) for VH4011499 (copies per milliliter)
  time frame: Baseline (Day 1) and up to Day 11
  description: Plasma samples will be collected for quantitative analysis of HIV-1 RNA
  arm group label: Part 1a - Participants Receiving VH4004280 Dose 1
  arm group type: Experimental
  arm group label: Part 1a - Participants Receiving VH4004280 Dose 2
  arm group type: Experimental
  arm group label: Part 1a - Participants Receiving VH4004280 Matching Placebo
  arm group type: Placebo Comparator
  arm group label: Part 1b - Participants Receiving VH4011499 Dose 1
  arm group type: Experimental
  arm group label: Part 1b - Participants Receiving VH4011499 Dose 2
  arm group type: Experimental
  arm group label: Part 1b - Participants Receiving VH4011499 Matching Placebo
  arm group type: Placebo Comparator
  arm group label: Part 2a - Participants Receiving VH4004280 Dose 3
  arm group type: Experimental
  arm group label: Part 2a - Participants Receiving VH4004280 Matching Placebo
  arm group type: Placebo Comparator
  arm group label: Part 2b - Participants Receiving VH4011499 Dose 3
  arm group type: Experimental
  arm group label: Part 2b - Participants Receiving VH4011499 Matching Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: VH4004280
  description: VH4004280 will be administered.
  arm group label: Part 1a - Participants Receiving VH4004280 Dose 1
  arm group label: Part 1a - Participants Receiving VH4004280 Dose 2
  arm group label: Part 2a - Participants Receiving VH4004280 Dose 3
  intervention type: Drug
  intervention name: VH4011499
  description: VH4011499 will be administered.
  arm group label: Part 1b - Participants Receiving VH4011499 Dose 1
  arm group label: Part 1b - Participants Receiving VH4011499 Dose 2
  arm group label: Part 2b - Participants Receiving VH4011499 Dose 3
  intervention type: Drug
  intervention name: VH4004280 Matching Placebo
  description: VH4004280 matching placebo will be administered.
  arm group label: Part 1a - Participants Receiving VH4004280 Matching Placebo
  arm group label: Part 2a - Participants Receiving VH4004280 Matching Placebo
  intervention type: Drug
  intervention name: VH4011499 Matching Placebo
  description: VH4011499 matching placebo will be administered.
  arm group label: Part 1b - Participants Receiving VH4011499 Matching Placebo
  arm group label: Part 2b - Participants Receiving VH4011499 Matching Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 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
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  country: Argentina
  country: Canada
  country: France
  country: Germany
  country: Italy
  country: Mexico
  country: Spain
  country: United Kingdom
  country: United States
  responsible party type: Sponsor
  mesh term: HIV Infections
  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/