<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/NCT03836833</url>
  </required_header>
  <id_info>
    <org_study_id>DNDi-4in1-01-PHIV</org_study_id>
    <nct_id>NCT03836833</nct_id>
  </id_info>
  <brief_title>Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation</brief_title>
  <acronym>LOLIPOP</acronym>
  <official_title>Pharmacokinetic, Safety and Acceptability Study of the Abacavir/Lamivudine/Lopinavir/Ritonavir/-30/15/ 40/10mg vs. Lopinavir/Ritonavir 40/10mg Pellets Plus Dual Abacavir/Lamivudine-60/30mg Tablets in HIV Infected Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Drugs for Neglected Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UNITAID</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AMS-PHPT Research Platform (Program for HIV Prevention and Treatment)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Joint Clinical Research Centre- Kampala</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor College of Medicine Childrens Foundation, Uganda</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Epcentre Centre Mbarara Research Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Tropical Medicine, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Drugs for Neglected Diseases</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability&#xD;
      study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose&#xD;
      Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg&#xD;
      tablets) in HIV infected Children.&#xD;
&#xD;
      The study is intended to support the adoption of the 4-in-1 by healthcare providers and will&#xD;
      provide data that may support its registration in certain countries. The study will be&#xD;
      carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to&#xD;
      swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety,&#xD;
      tolerability and acceptability of the 4-in-1.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to estimate the population average exposure to LPV, ABC and 3TC&#xD;
      provided by the 4-in-1 formulation in HIV-infected children dosed per WHO weight bands.&#xD;
&#xD;
      The secondary objectives:&#xD;
&#xD;
        -  To determine the proportion of children overall, and within each weight band, with a&#xD;
           lopinavir C12 &lt;1.0 mg/L while receiving the 4-in-1 formulation&#xD;
&#xD;
        -  To evaluate and compare the safety and tolerability of the 4-in-1 formulation versus a&#xD;
           reference treatment regimen.&#xD;
&#xD;
        -  To compare the bioavailability of LPV, ABC and 3TC in the 4-in-1 formulation versus a&#xD;
           reference treatment regimen.&#xD;
&#xD;
        -  To assess post exposure CD4 and viral load&#xD;
&#xD;
        -  To assess the factors that contribute to acceptability of the new 4-in-1 formulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 4, 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation</measure>
    <time_frame>0-12 hours</time_frame>
    <description>0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration at 12 hours for LPV in the 4in1 formulation</measure>
    <time_frame>12 hours</time_frame>
    <description>Plasma concentration at 12 hours for LPV in the 4in1 formulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak plasma concentration (Cmax) of LPV, ABC and 3TC with the 4-in-1 formulation.</measure>
    <time_frame>3-5 weeks</time_frame>
    <description>Plasma concentration maximum of LPV, ABC and 3TC with the 4-in-1 formulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration time maximum for LPV, ABC and 3TC with the 4-in-1 formulation.</measure>
    <time_frame>3-5 weeks</time_frame>
    <description>Concentration time maximum for LPV, ABC and 3TC with the 4-in-1 formulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance function for LPV, ABC and 3TC with the 4-in-1 formulation.</measure>
    <time_frame>3-5 weeks</time_frame>
    <description>Clearance function for LPV, ABC and 3TC with the 4-in-1 formulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen</measure>
    <time_frame>0 - 12 hours</time_frame>
    <description>Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under curve plasma concentration versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.</measure>
    <time_frame>0 - 12 hours</time_frame>
    <description>Area under curve plasma concentration versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC in the 4-in-1 formulation versus the reference treatment regimen.</measure>
    <time_frame>0 - 12 hours</time_frame>
    <description>Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC in the 4-in-1 formulation versus the reference treatment regimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak plasma concentration in the 4-in-1 formulation versus the reference treatment regimen.</measure>
    <time_frame>3-5 weeks</time_frame>
    <description>Peak plasma concentration in the 4-in-1 formulation versus the reference treatment regimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: A description of the proportion of children experiencing an Adverse event or Serious Adverse event binomial distribution compared between the two formulations.</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>Safety: A description of the proportion of children experiencing an Adverse event or Serious Adverse event binomial distribution compared between the two formulations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Summary of the number and percent of subjects with documented Grade 3 or higher adverse events; each summary will be conducted overall and by formulation</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>Safety: Summary of the number and percent of subjects with documented Grade 3 or higher adverse events; each summary will be conducted overall and by formulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of children with viral load &lt;1000 copies/ml</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>Comparison of proportion of children with viral load less than 1000 copies/ml at baseline and at end of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CD4 counts compared to baseline</measure>
    <time_frame>6-8 week</time_frame>
    <description>Changes in CD4 counts compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CD4 percentage compared to baseline</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>Changes in CD4 percentage compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability: Description of factors that affect acceptability of the 4 in1 formulation</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>Description of factors that affect acceptability of the 4in1 formulation as reported by the caregivers</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>4in1 granules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks, Followed by Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LPV/r Pellets Plus ABC/3TC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks.&#xD;
Followed by Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABC/3TC/LPV/r granules (30/15/40/10 mgs)</intervention_name>
    <description>This is a fixed dose combination. Each capsule contains Lopinavir (40mg), Ritonavir (10mg), Abacavir (30mg) and Lamivudine (15mg) in granules formulation.&#xD;
Dosage according to patient's weight:&#xD;
Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day</description>
    <arm_group_label>4in1 granules</arm_group_label>
    <arm_group_label>LPV/r Pellets Plus ABC/3TC</arm_group_label>
    <other_name>4in1 Granules</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)</intervention_name>
    <description>Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets)&#xD;
Dosage according to patient's weight:&#xD;
LPV/r Pellets:&#xD;
Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day&#xD;
ABC/3TC:&#xD;
Between 3 and 5.9kg: 1 tablet twice a day Between 6 and 9.9kg: 1.5 tablets twice a day Between 10 and 13.9kg: 2 tablets twice a day Between 14 and 19.9kg: 2.5 tablets twice a day Between 20 and 24.9kg: 3 tablets twice a day</description>
    <arm_group_label>4in1 granules</arm_group_label>
    <arm_group_label>LPV/r Pellets Plus ABC/3TC</arm_group_label>
    <other_name>L PV/r Pellets Plus ABC/3TC tablets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children &gt; 4 weeks old and weighing ≥3 and &lt;25 kg at the time of enrolment&#xD;
&#xD;
          -  Past or current documentation of a confirmed diagnosis of HIV infection defined as two&#xD;
             positive assays from two different samples. The two results may be in any combination&#xD;
             of the following:&#xD;
&#xD;
          -  At any age: HIV-1 DNA PCR positive&#xD;
&#xD;
          -  Documented past HIV-1 RNA viral load &gt; 1,000 copies/mL plasma&#xD;
&#xD;
          -  At any age &gt;18 months of age: HIV-1 antibody reactive on two different rapid tests&#xD;
             based on national testing algorithm&#xD;
&#xD;
          -  ARV treatment eligible children with LPV-based treatment indication* as defined by&#xD;
             country-specific guidelines or the WHO paediatric treatment guidelines and confirmed&#xD;
             by the investigator&#xD;
&#xD;
          -  HIV RNA viral load &lt;1000 copies/mL (suppressed) at the screening visit*&#xD;
&#xD;
          -  Inability to swallow LPV/r tablets&#xD;
&#xD;
          -  Parent or guardian able and willing to provide written informed consent.&#xD;
&#xD;
          -  For lowest weight band (≥3 and ≤ 5.9kgs) ONLY: under treatment for at least 3 weeks&#xD;
             but not more than 12 weeks.&#xD;
&#xD;
               -  Does not apply to the youngest children (≥3 and ≤ 5.9kgs)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned or concurrent use of NNRTIs, integrase inhibitors, entry inhibitors, or&#xD;
             Protease Inhibitors (PIs) other than LPV/r.&#xD;
&#xD;
          -  Treatment failure with proven resistances to PIs.&#xD;
&#xD;
          -  Contraindication to use of PIs&#xD;
&#xD;
          -  Clinical condition requiring the use of a prohibited medication (see section 7.6) in&#xD;
             association with LPV/r, ABC/3TC (Refer to section 7.2- 7.3 of the IB)&#xD;
&#xD;
          -  Pulmonary Tuberculosis and any clinically significant disease or finding during&#xD;
             screening that, in the investigator's opinion, would compromise participation in this&#xD;
             study.&#xD;
&#xD;
          -  Treatment with experimental drugs (except for LPV/r Pellets) for any indication within&#xD;
             30 days prior to study entry&#xD;
&#xD;
          -  Anticipated transfer of care to a non-participating health facility during the study&#xD;
             period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Weeks</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabelle Andrieux-Meyer, MD</last_name>
    <role>Study Director</role>
    <affiliation>Drugs for Neglected Diseases initiative</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Isabelle Andrieux-Meyer, MD</last_name>
    <phone>+41 22 906 92 68</phone>
    <email>iandrieux-meyer@dndi.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Baylor College of Medicine Children's Foundation Uganda</name>
      <address>
        <city>Kampala</city>
        <country>Uganda</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. Adeodata Kekitiinwa, MBChM, MMeD</last_name>
      <phone>+256772462686</phone>
      <email>akekitiinwa@baylor-uganda.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Joint Clinical research Centre</name>
      <address>
        <city>Kampala</city>
        <country>Uganda</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victor Musiime, MBChB,PhD</last_name>
      <phone>+256 417 723000</phone>
      <email>vmusiime@jcrc.org.ug</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Epicentre Mbarara Research Centre</name>
      <address>
        <city>Mbarara</city>
        <country>Uganda</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. Juliet Mwanga, MBChB, MMED</last_name>
      <phone>+256 793328748</phone>
      <email>juliet.mwanga@epicentre.msf.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>June 5, 2019</last_update_submitted>
  <last_update_submitted_qc>June 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lamivudine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 21, 2022</submitted>
    <returned>March 23, 2022</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03836833
org study id: DNDi-4in1-01-PHIV
nct id: NCT03836833
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability
      study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose
      Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg
      tablets) in HIV infected Children.

      The study is intended to support the adoption of the 4-in-1 by healthcare providers and will
      provide data that may support its registration in certain countries. The study will be
      carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to
      swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety,
      tolerability and acceptability of the 4-in-1.
The primary objective is to estimate the population average exposure to LPV, ABC and 3TC
      provided by the 4-in-1 formulation in HIV-infected children dosed per WHO weight bands.

      The secondary objectives:

        -  To determine the proportion of children overall, and within each weight band, with a
           lopinavir C12 <1.0 mg/L while receiving the 4-in-1 formulation

        -  To evaluate and compare the safety and tolerability of the 4-in-1 formulation versus a
           reference treatment regimen.

        -  To compare the bioavailability of LPV, ABC and 3TC in the 4-in-1 formulation versus a
           reference treatment regimen.

        -  To assess post exposure CD4 and viral load

        -  To assess the factors that contribute to acceptability of the new 4-in-1 formulation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation
time frame: 0-12 hours
description: 0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation
measure: Plasma concentration at 12 hours for LPV in the 4in1 formulation
time frame: 12 hours
description: Plasma concentration at 12 hours for LPV in the 4in1 formulation
measure: Peak plasma concentration (Cmax) of LPV, ABC and 3TC with the 4-in-1 formulation.
time frame: 3-5 weeks
description: Plasma concentration maximum of LPV, ABC and 3TC with the 4-in-1 formulation.
measure: Concentration time maximum for LPV, ABC and 3TC with the 4-in-1 formulation.
time frame: 3-5 weeks
description: Concentration time maximum for LPV, ABC and 3TC with the 4-in-1 formulation.
measure: Clearance function for LPV, ABC and 3TC with the 4-in-1 formulation.
time frame: 3-5 weeks
description: Clearance function for LPV, ABC and 3TC with the 4-in-1 formulation.
measure: Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen
time frame: 0 - 12 hours
description: Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.
measure: Area under curve plasma concentration versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.
time frame: 0 - 12 hours
description: Area under curve plasma concentration versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.
measure: Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC in the 4-in-1 formulation versus the reference treatment regimen.
time frame: 0 - 12 hours
description: Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC in the 4-in-1 formulation versus the reference treatment regimen.
measure: Peak plasma concentration in the 4-in-1 formulation versus the reference treatment regimen.
time frame: 3-5 weeks
description: Peak plasma concentration in the 4-in-1 formulation versus the reference treatment regimen.
measure: Safety: A description of the proportion of children experiencing an Adverse event or Serious Adverse event binomial distribution compared between the two formulations.
time frame: 6-8 weeks
description: Safety: A description of the proportion of children experiencing an Adverse event or Serious Adverse event binomial distribution compared between the two formulations.
measure: Safety: Summary of the number and percent of subjects with documented Grade 3 or higher adverse events; each summary will be conducted overall and by formulation
time frame: 6-8 weeks
description: Safety: Summary of the number and percent of subjects with documented Grade 3 or higher adverse events; each summary will be conducted overall and by formulation
measure: Proportion of children with viral load <1000 copies/ml
time frame: 6-8 weeks
description: Comparison of proportion of children with viral load less than 1000 copies/ml at baseline and at end of the study.
measure: Changes in CD4 counts compared to baseline
time frame: 6-8 week
description: Changes in CD4 counts compared to baseline
measure: Changes in CD4 percentage compared to baseline
time frame: 6-8 weeks
description: Changes in CD4 percentage compared to baseline
measure: Acceptability: Description of factors that affect acceptability of the 4 in1 formulation
time frame: 6-8 weeks
description: Description of factors that affect acceptability of the 4in1 formulation as reported by the caregivers
arm group label: 4in1 granules
arm group type: Experimental
description: Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks, Followed by Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks.
arm group label: LPV/r Pellets Plus ABC/3TC
arm group type: Experimental
description: Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks.
Followed by Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks
intervention type: Drug
intervention name: ABC/3TC/LPV/r granules (30/15/40/10 mgs)
description: This is a fixed dose combination. Each capsule contains Lopinavir (40mg), Ritonavir (10mg), Abacavir (30mg) and Lamivudine (15mg) in granules formulation.
Dosage according to patient's weight:
Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day
arm group label: 4in1 granules
arm group label: LPV/r Pellets Plus ABC/3TC
other name: 4in1 Granules
intervention type: Drug
intervention name: LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)
description: Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets)
Dosage according to patient's weight:
LPV/r Pellets:
Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day
ABC/3TC:
Between 3 and 5.9kg: 1 tablet twice a day Between 6 and 9.9kg: 1.5 tablets twice a day Between 10 and 13.9kg: 2 tablets twice a day Between 14 and 19.9kg: 2.5 tablets twice a day Between 20 and 24.9kg: 3 tablets twice a day
arm group label: 4in1 granules
arm group label: LPV/r Pellets Plus ABC/3TC
other name: L PV/r Pellets Plus ABC/3TC tablets
criteria: 
gender: All
minimum age: 4 Weeks
maximum age: N/A
healthy volunteers: No
last name: Isabelle Andrieux-Meyer, MD
role: Study Director
affiliation: Drugs for Neglected Diseases initiative
last name: Isabelle Andrieux-Meyer, MD
phone: +41 22 906 92 68
email: iandrieux-meyer@dndi.org
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Uganda
responsible party type: Sponsor
mesh term: Lamivudine
sharing ipd: Undecided
submitted: January 21, 2022
returned: March 23, 2022