<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/NCT04489953</url>
  </required_header>
  <id_info>
    <org_study_id>9415</org_study_id>
    <nct_id>NCT04489953</nct_id>
  </id_info>
  <brief_title>Comparison of Treatment Failure Criteria in HIV-Infected Children in Uganda</brief_title>
  <official_title>Optimizing Antiretroviral Treatment Switch in HIV-Infected Ugandan Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MU-JHU CARE</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MU-JHU CARE</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main goal was to compare clinical and immunological versus clinical, immunological plus&#xD;
      viral load criteria for switching to second-line ART by comparing 48 week treatment outcomes,&#xD;
      including survival rates, viral suppression, failure to thrive, and AIDS-defining illnesses&#xD;
      for treatment experienced children randomized to two switching criteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of the study was aimed at determining whether the use of the current WHO&#xD;
      criteria alone (clinical and immunologic) to define treatment failure as the trigger for&#xD;
      switching to second-line antiretroviral therapy leads to poorer 6 month and 12 month&#xD;
      treatment outcomes when compared to combining clinical and immunologic parameters with viral&#xD;
      load (VL) monitoring.&#xD;
&#xD;
      In addition the study aimed at obtaining plasma samples from treatment experienced children,&#xD;
      for future resistance testing. The results of this study may help guide WHO and national&#xD;
      pediatric ART programs on the need for routine VL monitoring for children initiating HAART in&#xD;
      resource limited settings, where virologic tests including resistance testing are not readily&#xD;
      available or affordable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2013</start_date>
  <completion_date type="Actual">January 16, 2017</completion_date>
  <primary_completion_date type="Actual">January 16, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Criteria for switching HIV-Infected Children to second line</measure>
    <time_frame>2 years</time_frame>
    <description>Confirmed viral load &gt; 1,000 HIV RNA copies/ml</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Clinical and Immunologic criteria</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the clinical and immunologic monitoring criteria was based on the 2010 WHO guidelines. Whereby children were monitored using clinical presentation and CD4 count to define treatment failure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinical, Immunologic and Virologic criteria</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the Clinical, Immunologic and Virologic criteria was based on a confirmed viral load of &gt; 1000 HIV RNA copies/ml; as well as clinical and immunologic criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Viral Load</intervention_name>
    <description>For the Clinical and Immunologic criteria, viral load was done retrospectively on stored plasma samples. Whereas for the Clinical, Immunologic and Virologic criteria, viral load was done in real-time</description>
    <arm_group_label>Clinical and Immunologic criteria</arm_group_label>
    <arm_group_label>Clinical, Immunologic and Virologic criteria</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-Infected Children, 1 year to 12 years&#xD;
&#xD;
          -  ART experienced and enrolled in an existing treatment program that used clinical and&#xD;
             immunologic criteria to monitor response to ART.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04489953
org study id: 9415
nct id: NCT04489953
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main goal was to compare clinical and immunological versus clinical, immunological plus
      viral load criteria for switching to second-line ART by comparing 48 week treatment outcomes,
      including survival rates, viral suppression, failure to thrive, and AIDS-defining illnesses
      for treatment experienced children randomized to two switching criteria.
The overall goal of the study was aimed at determining whether the use of the current WHO
      criteria alone (clinical and immunologic) to define treatment failure as the trigger for
      switching to second-line antiretroviral therapy leads to poorer 6 month and 12 month
      treatment outcomes when compared to combining clinical and immunologic parameters with viral
      load (VL) monitoring.

      In addition the study aimed at obtaining plasma samples from treatment experienced children,
      for future resistance testing. The results of this study may help guide WHO and national
      pediatric ART programs on the need for routine VL monitoring for children initiating HAART in
      resource limited settings, where virologic tests including resistance testing are not readily
      available or affordable.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Criteria for switching HIV-Infected Children to second line
time frame: 2 years
description: Confirmed viral load > 1,000 HIV RNA copies/ml
arm group label: Clinical and Immunologic criteria
arm group type: Active Comparator
description: In the clinical and immunologic monitoring criteria was based on the 2010 WHO guidelines. Whereby children were monitored using clinical presentation and CD4 count to define treatment failure.
arm group label: Clinical, Immunologic and Virologic criteria
arm group type: Active Comparator
description: In the Clinical, Immunologic and Virologic criteria was based on a confirmed viral load of > 1000 HIV RNA copies/ml; as well as clinical and immunologic criteria
intervention type: Other
intervention name: Viral Load
description: For the Clinical and Immunologic criteria, viral load was done retrospectively on stored plasma samples. Whereas for the Clinical, Immunologic and Virologic criteria, viral load was done in real-time
arm group label: Clinical and Immunologic criteria
arm group label: Clinical, Immunologic and Virologic criteria
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor