<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/NCT03016533</url>
  </required_header>
  <id_info>
    <org_study_id>205858</org_study_id>
    <nct_id>NCT03016533</nct_id>
  </id_info>
  <brief_title>Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019</brief_title>
  <official_title>Open-label Access to Dolutegravir for HIV-1 Infected Children and Adolescents Completing IMPAACT Studies P1093 and P2019</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dolutegravir is a potent integrase strand transfer inhibitor.&#xD;
      Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing&#xD;
      two nucleoside reverse transcriptase inhibitors and dolutegravir. This is a phase 3b,&#xD;
      non-randomized, open-label, multi-center, two treatment rollover study. The primary objective&#xD;
      of this pediatric interventional study is to provide continued access to age appropriate&#xD;
      formulations of investigational product (dolutegravir), either as Tivicay or as part of fixed&#xD;
      dose combination ABC/DTG/3TC, for eligible participants who previously participated in parent&#xD;
      studies P1093 (NCT01302847) or P2019 (NCT03760458) and who cannot locally access age&#xD;
      appropriate formulations of dolutegravir or ABC/DTG/3TC in the public sector. The P1093 study&#xD;
      was designed to evaluate the pharmacokinetics (PK), safety, tolerability and antiviral&#xD;
      activity of dolutegravir in combination with optimized background regimens in human&#xD;
      immunodeficiency virus type 1 (HIV-1) experienced adolescents and children as well as&#xD;
      treatment naïve infants and toddlers. The P2019 study was designed to evaluate PK, safety,&#xD;
      tolerability and antiviral activity of ABC/DTG/3TC dispersible and immediate release tablets&#xD;
      in HIV-1-infected children. Participants who have tolerated investigational product in the&#xD;
      parent studies without any significant toxicity or signs of virologic failure leading to the&#xD;
      permanent discontinuation of investigational product and withdrawal from the parent study&#xD;
      will be considered for this open label continued access study. Participants will receive&#xD;
      their age/weight appropriate dose of investigational product as defined in the parent study.&#xD;
      The duration of participation in the study will extend until age appropriate formulations of&#xD;
      Tivicay or ABC/DTG/3TC receive local (by country) regulatory approval and are available in&#xD;
      those countries from another source (e.g. government programs, aid programs, assistance&#xD;
      programs, etc.) or the participant is no longer deriving benefit from treatment or meets a&#xD;
      protocol defined reason for discontinuation. Participants will be enrolled after all&#xD;
      screening procedures have been completed. In most cases, the Screening visit will overlap&#xD;
      with the participants penultimate visit on the parent study (at Week 180 of P1093, or Week 36&#xD;
      of the P2019 study). Participants who meet all entry criteria may enroll and will be seen in&#xD;
      the clinic every 12 weeks for a safety evaluation and to receive investigational product. It&#xD;
      is estimated that no more than 300 participants will be enrolled in this study. Tivicay is a&#xD;
      registered trademark of ViiV Healthcare.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 6, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with continued access to age appropriate formulation of dolutegravir</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>To provide access to age appropriate formulation of investigational product (dolutegravir), either as Tivicay or as fixed dose combination ABC/DTG/3TC in an open-label protocol to eligible participants who have completed P1093 and P2019 studies respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with serious adverse events (SAEs) as a measure of safety</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with SAEs based on the severity</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. The Division of acquired immunodeficiency syndrome (DAIDS) table for grading the severity of adult and pediatric adverse events will be used to assess severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with any clinical or laboratory adverse events leading to discontinuation of investigational product</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>An adverse event is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the investigational product.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Dolutegravir (Tivicay)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive dolutegravir film-coated tablets or film-coated dispersible tablets at appropriate doses selected as per their age and weight bands. For those participants who were previously receiving dolutegravir in study P1093 (parent study), dolutegravir will be supplied as film-coated tablets containing 50 mg; and 5 mg film-coated dispersible tablets of dolutegravir. Participants will receive dolutegravir until age-appropriate formulations are available to them from some other source, or until participant is no longer deriving benefit from treatment, or participant is discontinued, or until development of dolutegravir is terminated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABC/DTG/3TC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets at appropriate doses selected as per their weight bands. For those participants who were previously receiving ABC/DTG/3TC in study P2019 (parent study), ABC/DTG/3TC will be supplied as immediate release tablets containing 600 mg, 50 mg and 300 mg of ABC, DTG, and 3TC respectively and film-coated dispersible tablets containing 60 mg, 5 mg and 30 mg of ABC, DTG, and 3TC respectively. Participants will receive ABC/DTG/3TC until age-appropriate formulations are available to them from some other source, until participant is no longer deriving benefit from treatment, or until participant is discontinued, or until development of ABC/DTG/3TC is terminated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dolutegravir film-coated tablets</intervention_name>
    <description>Dolutegravir film-coated tablets will be provided as 50 mg tablets.</description>
    <arm_group_label>Dolutegravir (Tivicay)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dolutegravir film-coated dispersible tablets</intervention_name>
    <description>Dolutegravir film-coated dispersible tablets will be provided as 5 mg dispersible tablets. It will be administered at the appropriate dose as determined by results of the parent protocol to participants as per their age and weight band.</description>
    <arm_group_label>Dolutegravir (Tivicay)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABC/DTG/3TC immediate release tablets</intervention_name>
    <description>ABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC.</description>
    <arm_group_label>ABC/DTG/3TC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABC/DTG/3TC film-coated dispersible tablets</intervention_name>
    <description>ABC/DTG/3TC dispersible tablets will be provided as biconvex, oval, film-coated tablets containing 60 mg ABC, 5 mg DTG and 30 mg 3TC.</description>
    <arm_group_label>ABC/DTG/3TC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must have completed participation in one of the following parent studies,&#xD;
             for the duration noted, with continued benefit from investigational product:&#xD;
&#xD;
               1. P1093 parent study through at least Week 180;&#xD;
&#xD;
               2. P2019 parent study through at least Week 48.&#xD;
&#xD;
          -  Participant with evidence of Virological Failure in either parent study must have&#xD;
             eligibility for this rollover study discussed and agreed with the ViiV Healthcare&#xD;
             Medical Monitor.&#xD;
&#xD;
          -  Virological control:&#xD;
&#xD;
               1. Participants in parent study P1093 must have virological control defined as HIV-1&#xD;
                  ribonucleic acid (RNA) &lt;400 copies per milliliter (c/mL) at their penultimate&#xD;
                  visit (on or after the Week 180 visit);&#xD;
&#xD;
               2. Participants in parent study P2019 must have virological control defined as HIV-1&#xD;
                  RNA &lt;200 c/mL at their penultimate visit (on or after Week 36).&#xD;
&#xD;
          -  Evidence of continued benefit from IP during the subject's participation in the parent&#xD;
             study (P1093 or P2019)&#xD;
&#xD;
               1. At screening, Investigators will submit a clinical summary verifying evidence of&#xD;
                  continued benefit from IP during the subject's participation in the parent study&#xD;
                  (P1093 or P2019).&#xD;
&#xD;
               2. The summary will be submitted via the PPD ePIP system to the Study Medical&#xD;
                  Monitor who will review and confirm if the inclusion criterion has been met.&#xD;
&#xD;
               3. Confirmation from the Study Medical Monitor is required to meet this eligibility&#xD;
                  criterion&#xD;
&#xD;
          -  Males and Females: All participants who are engaging in sexual activity should be&#xD;
             counseled on safer sexual practices including the use and benefit/risk of effective&#xD;
             barrier methods (example [e.g.] male condom) and on the risk of HIV transmission to an&#xD;
             uninfected partner. Females: Female participants who are of child- bearing potential&#xD;
             and who are engaging in sexual activity that could lead to pregnancy, must agree to&#xD;
             use one of the acceptable birth control methods until the last dose of study&#xD;
             medication and completion of the follow-up visit (4 weeks after the last dose).&#xD;
             Condoms are recommended in addition, because their appropriate use is the only&#xD;
             contraception method effective for preventing HIV-1 transmission.&#xD;
&#xD;
          -  Parent or legal guardian or participant &gt;=18 years of age is able and willing to&#xD;
             provide signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Confirmed virologic failure with evidence of resistance to:&#xD;
&#xD;
               1. DTG in the P1093 parent study, or&#xD;
&#xD;
               2. ABC, DTG or 3TC (with the exception of M184V) in the P2019 parent study&#xD;
&#xD;
          -  Presence of any active AIDS defining opportunistic infection.&#xD;
&#xD;
          -  Known &gt;=grade 3 laboratory toxicities prior to study entry (e.g. neutrophil count,&#xD;
             hemoglobin, platelets, aspartate aminotransferase [AST], alanine aminotransferase&#xD;
             [ALT], lipase, serum creatinine and total bilirubin) would be considered exclusionary&#xD;
             if identified at or after the penultimate parent study visit, prior to enrollment in&#xD;
             the study... Repeat testing is allowed for eligibility determination.&#xD;
&#xD;
          -  Previous permanent discontinuation from investigational product in the parent study&#xD;
             due to toxicity, intolerance or pregnancy.&#xD;
&#xD;
          -  Known ALT &gt;=5 times the upper limit of normal (ULN), or ALT &gt;=3 times ULN and&#xD;
             bilirubin &gt;=1.5 times ULN (with &gt;35 percent [%] direct bilirubin) would be considered&#xD;
             exclusionary if identified at or after the penultimate parent study visit, prior to&#xD;
             enrolment in the study.. Participants with moderate to severe hepatic impairment&#xD;
             (Class B or greater) as determined by Child-Pugh classification should be excluded.&#xD;
&#xD;
          -  Participants positive for hepatitis B virus at any time prior to entry (hepatitis B&#xD;
             virus surface antigen positive).&#xD;
&#xD;
          -  Females who are pregnant or plan to become pregnant or breastfeed during the study.&#xD;
&#xD;
          -  Participant is currently participating in or has participated in a study with a&#xD;
             compound or device that is not commercially available within 30 days of signing&#xD;
             informed consent, unless permission from the sponsor's medical monitor is granted.&#xD;
&#xD;
          -  Presence of any history of allergy/sensitivity to any of the study drugs.&#xD;
&#xD;
          -  Participants transitioning from the P2019 study (taking ABC/DTG/3TC) have evidence of&#xD;
             being Human Leukocyte Antigen-B*5701- positive based on documented testing at any time&#xD;
             prior to entry.&#xD;
&#xD;
          -  Use of any disallowed medications at time of Screening.&#xD;
&#xD;
          -  Anticipated need for Hepatitis C virus therapy with interferon or any drugs that have&#xD;
             potential for adverse drug: drug interactions with study treatment throughout the&#xD;
             entire study period.&#xD;
&#xD;
          -  Participant is unlikely to adhere to the study procedures, keep appointments, or is&#xD;
             planning to relocate during the study.&#xD;
&#xD;
          -  Clinical or symptomatic evidence of pancreatitis, as determined by the clinician.&#xD;
&#xD;
          -  Any condition (including but not limited to alcohol and drug use) that would, in the&#xD;
             opinion of the site investigator, place the participant at an unacceptable risk of&#xD;
             injury or render the participant unable to meet the requirements of the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>25 Years</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>
  <overall_contact>
    <last_name>US GSK Clinical Trials Call Center</last_name>
    <phone>877-379-3718</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>EU GSK Clinical Trials Call Center</last_name>
    <phone>+44 (0) 20 89904466</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jaime G DeVille</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Lisa Gay Robinson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105-3678</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Patricia Flynn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gaborone</city>
        <country>Botswana</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Gaerolwe R Masheto</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30130-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jorge Andrade Pinto</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ribeirao Preto</city>
        <state>São Paulo</state>
        <zip>14048-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Marisa Márcia Mussi-Pinhata</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21941-612</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ricardo Hugo Oliveira</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>26030-380</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jose Henrique de Silva Pilotto</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hillbrow</city>
        <state>Gauteng</state>
        <zip>2001</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Lee Fairlie</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7505</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Mark Cotton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Soweto</city>
        <zip>1862</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Haseena Cassim</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Umlazi</city>
        <zip>4066</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Moherndran Archary</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moshi</city>
        <zip>3010</zip>
        <country>Tanzania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
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    <investigator>
      <last_name>Blandina MMbaga</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Kulkanya Chokephaibulkit</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiangrai</city>
        <zip>57000</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Pradthana Ounchanum</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Muang</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Linda Aurpibul</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Harare</city>
        <country>Zimbabwe</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Mutsawashe Bwakura-Dangarembizi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Botswana</country>
    <country>Brazil</country>
    <country>South Africa</country>
    <country>Tanzania</country>
    <country>Thailand</country>
    <country>United States</country>
    <country>Zimbabwe</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dolutegravir</keyword>
  <keyword>Continued access study</keyword>
  <keyword>HIV-1</keyword>
  <keyword>ABC/DTG/3TC</keyword>
  <keyword>Pediatric</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>Lamivudine</mesh_term>
    <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 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>
  <!-- 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/NCT03016533
org study id: 205858
nct id: NCT03016533
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Dolutegravir is a potent integrase strand transfer inhibitor.
      Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing
      two nucleoside reverse transcriptase inhibitors and dolutegravir. This is a phase 3b,
      non-randomized, open-label, multi-center, two treatment rollover study. The primary objective
      of this pediatric interventional study is to provide continued access to age appropriate
      formulations of investigational product (dolutegravir), either as Tivicay or as part of fixed
      dose combination ABC/DTG/3TC, for eligible participants who previously participated in parent
      studies P1093 (NCT01302847) or P2019 (NCT03760458) and who cannot locally access age
      appropriate formulations of dolutegravir or ABC/DTG/3TC in the public sector. The P1093 study
      was designed to evaluate the pharmacokinetics (PK), safety, tolerability and antiviral
      activity of dolutegravir in combination with optimized background regimens in human
      immunodeficiency virus type 1 (HIV-1) experienced adolescents and children as well as
      treatment naïve infants and toddlers. The P2019 study was designed to evaluate PK, safety,
      tolerability and antiviral activity of ABC/DTG/3TC dispersible and immediate release tablets
      in HIV-1-infected children. Participants who have tolerated investigational product in the
      parent studies without any significant toxicity or signs of virologic failure leading to the
      permanent discontinuation of investigational product and withdrawal from the parent study
      will be considered for this open label continued access study. Participants will receive
      their age/weight appropriate dose of investigational product as defined in the parent study.
      The duration of participation in the study will extend until age appropriate formulations of
      Tivicay or ABC/DTG/3TC receive local (by country) regulatory approval and are available in
      those countries from another source (e.g. government programs, aid programs, assistance
      programs, etc.) or the participant is no longer deriving benefit from treatment or meets a
      protocol defined reason for discontinuation. Participants will be enrolled after all
      screening procedures have been completed. In most cases, the Screening visit will overlap
      with the participants penultimate visit on the parent study (at Week 180 of P1093, or Week 36
      of the P2019 study). Participants who meet all entry criteria may enroll and will be seen in
      the clinic every 12 weeks for a safety evaluation and to receive investigational product. It
      is estimated that no more than 300 participants will be enrolled in this study. Tivicay is a
      registered trademark of ViiV Healthcare.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with continued access to age appropriate formulation of dolutegravir
time frame: Up to 4 years
description: To provide access to age appropriate formulation of investigational product (dolutegravir), either as Tivicay or as fixed dose combination ABC/DTG/3TC in an open-label protocol to eligible participants who have completed P1093 and P2019 studies respectively.
measure: Number of participants with serious adverse events (SAEs) as a measure of safety
time frame: Up to 2 years
description: An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function.
measure: Number of participants with SAEs based on the severity
time frame: Up to 2 years
description: An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. The Division of acquired immunodeficiency syndrome (DAIDS) table for grading the severity of adult and pediatric adverse events will be used to assess severity.
measure: Number of participants with any clinical or laboratory adverse events leading to discontinuation of investigational product
time frame: Up to 2 years
description: An adverse event is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the investigational product.
arm group label: Dolutegravir (Tivicay)
arm group type: Experimental
description: All participants will receive dolutegravir film-coated tablets or film-coated dispersible tablets at appropriate doses selected as per their age and weight bands. For those participants who were previously receiving dolutegravir in study P1093 (parent study), dolutegravir will be supplied as film-coated tablets containing 50 mg; and 5 mg film-coated dispersible tablets of dolutegravir. Participants will receive dolutegravir until age-appropriate formulations are available to them from some other source, or until participant is no longer deriving benefit from treatment, or participant is discontinued, or until development of dolutegravir is terminated.
arm group label: ABC/DTG/3TC
arm group type: Experimental
description: All participants will receive ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets at appropriate doses selected as per their weight bands. For those participants who were previously receiving ABC/DTG/3TC in study P2019 (parent study), ABC/DTG/3TC will be supplied as immediate release tablets containing 600 mg, 50 mg and 300 mg of ABC, DTG, and 3TC respectively and film-coated dispersible tablets containing 60 mg, 5 mg and 30 mg of ABC, DTG, and 3TC respectively. Participants will receive ABC/DTG/3TC until age-appropriate formulations are available to them from some other source, until participant is no longer deriving benefit from treatment, or until participant is discontinued, or until development of ABC/DTG/3TC is terminated.
intervention type: Drug
intervention name: Dolutegravir film-coated tablets
description: Dolutegravir film-coated tablets will be provided as 50 mg tablets.
arm group label: Dolutegravir (Tivicay)
intervention type: Drug
intervention name: Dolutegravir film-coated dispersible tablets
description: Dolutegravir film-coated dispersible tablets will be provided as 5 mg dispersible tablets. It will be administered at the appropriate dose as determined by results of the parent protocol to participants as per their age and weight band.
arm group label: Dolutegravir (Tivicay)
intervention type: Drug
intervention name: ABC/DTG/3TC immediate release tablets
description: ABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC.
arm group label: ABC/DTG/3TC
intervention type: Drug
intervention name: ABC/DTG/3TC film-coated dispersible tablets
description: ABC/DTG/3TC dispersible tablets will be provided as biconvex, oval, film-coated tablets containing 60 mg ABC, 5 mg DTG and 30 mg 3TC.
arm group label: ABC/DTG/3TC
criteria: 
gender: All
minimum age: N/A
maximum age: 25 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: ViiV Healthcare
last name: US GSK Clinical Trials Call Center
phone: 877-379-3718
email: GSKClinicalSupportHD@gsk.com
last name: EU GSK Clinical Trials Call Center
phone: +44 (0) 20 89904466
email: GSKClinicalSupportHD@gsk.com
facility: 
status: Recruiting
contact: 
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country: Botswana
country: Brazil
country: South Africa
country: Tanzania
country: Thailand
country: United States
country: Zimbabwe
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Lamivudine
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 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