<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/NCT03275701</url>
  </required_header>
  <id_info>
    <org_study_id>205773</org_study_id>
    <nct_id>NCT03275701</nct_id>
  </id_info>
  <brief_title>Evaluating BMD in Participants ≥50 Years Old Switching From EVG/COBI/FTC/TAF or EVG/COBI/FTC/TDF to ABC/DTG/3TC</brief_title>
  <acronym>STRUCTR</acronym>
  <official_title>Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected Adults ≥50 Years Old Switching From EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild) to ABC/DTG/3TC (Triumeq)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mills Clinical Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ViiV Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mills Clinical Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected&#xD;
      Adults ≥50 Years Old Switching from EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild)&#xD;
      to ABC/DTG/3TC (Triumeq)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected&#xD;
      Adults ≥50 Years Old Switching from EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild)&#xD;
      to ABC/DTG/3TC (Triumeq)&#xD;
&#xD;
      To evaluate the impact on BMD, as measured by DEXA over 48 weeks, of switching from an&#xD;
      INSTI-based regimen with either TDF or TAF to a regimen of ABC/DTG/3TC (administered as&#xD;
      commercial Triumeq) in chronic HIV-infected patients over the age of 50&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change from Baseline at Week 48 in total hip BMD (measured by DEXA)</measure>
    <time_frame>48 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change from Baseline at Week 48 in lumbar spine BMD (measured by DEXA)</measure>
    <time_frame>48 Weeks</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Change from Baseline in bone biomarkers for individuals switching to ABC/DTG/3TC</measure>
    <time_frame>96 Weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in bone mineral density (in lumbar spine and total hip) assessed by T-scores and Z-scores from Baseline in individuals switching to ABC/DTG/3TC</measure>
    <time_frame>96 Weeks</time_frame>
    <description>Z-score = (Patient's BMD - expected BMD) / SD; T-score = (BMD-Reference BMD)/SD Units are numerical in value. BMD)/SD Units are numerical in value.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of adverse events (including long-term virologic/immunologic responses, abnormal laboratory values, or untoward medical conditions) for individuals switching to ABC/DTG/3TC</measure>
    <time_frame>96 Weeks</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Infection, Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>Triumeq</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single Arm, Open Label</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triumeq</intervention_name>
    <description>Open Label, Switch to Triumeq (ABC/DTG/3TC)</description>
    <arm_group_label>Triumeq</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Documented HIV-1 infection;&#xD;
&#xD;
          2. At least 50 years of age;&#xD;
&#xD;
          3. Currently on a stable antiretroviral regimen (for ≥3 months preceding Screening) of&#xD;
             either EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild);&#xD;
&#xD;
          4. HIV is currently suppressed, defined as:&#xD;
&#xD;
               1. Plasma HIV-1 RNA &lt;50 c/mL for ≥3 months preceding Screening; AND&#xD;
&#xD;
               2. Plasma HIV-1 RNA &lt;50 copies/mL at the Screening assessment; INCL 5. Documentation&#xD;
                  that the participant is negative for the human leukocyte antigen (HLA)-B*5701&#xD;
                  allele.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant, breastfeeding, or planning to become pregnant during the study period;&#xD;
&#xD;
          2. Bilateral hip replacement;&#xD;
&#xD;
          3. Exceeds weight limit for DEXA equipment (i.e., weighs &gt;350 lbs or &gt;159 kg);&#xD;
&#xD;
          4. History or presence of allergy to the study treatment (Triumeq) or any of its&#xD;
             components (to ABC, DTG, or 3TC);&#xD;
&#xD;
          5. Active Centers for Disease Control and Prevention (CDC) Category C HIV-1 disease (see&#xD;
             Section 17.1 for definition), with the exception of cutaneous Kaposi's sarcoma, not&#xD;
             requiring systemic therapy and historic CD4+ cell counts of &lt;200 cells/mm3;&#xD;
&#xD;
          6. Positive for hepatitis B virus surface antigen (HBsAg) at Screening;&#xD;
&#xD;
          7. Ongoing malignancies (other than localized malignancies, such as cutaneous Kaposi's&#xD;
             sarcoma, basal cell carcinoma, cervical intraepithelial neoplasia);&#xD;
&#xD;
          8. Significant suicidal risk in the investigator's opinion;&#xD;
&#xD;
          9. Metabolic disease;&#xD;
&#xD;
         10. Treatment with HIV immunotherapeutic vaccine within 90 days of Screening;&#xD;
&#xD;
         11. Radiation, cytotoxic chemotherapy, or any immunomodulator (that alters immune&#xD;
             responses) within 28 days of Screening;&#xD;
&#xD;
         12. Exposure to any experimental drug or vaccine within 28 days or 5 half-lives of the&#xD;
             test agent, or twice the duration of the biological effect of the test agent,&#xD;
             whichever is longer, prior to first dose of study treatment on Day 1;&#xD;
&#xD;
         13. History of use of only mono or dual NRTI therapy prior to starting combination ART for&#xD;
             the treatment of HIV infection (except that prior NRTI use for the purpose of&#xD;
             pre-exposure prophylaxis [PrEP] or postexposure prophylaxis [PEP] is not excluded);&#xD;
&#xD;
         14. Became HIV-positive (i.e., had a detectable plasma HIV-1 viral load) while taking PrEP&#xD;
             or PEP;&#xD;
&#xD;
         15. Documented resistance to any component of the study treatment (ABC, DTG, or 3TC) as&#xD;
             indicated by either:&#xD;
&#xD;
               1. Historical genotype in the participant's medical record; OR&#xD;
&#xD;
               2. Genotype obtained by GenoSure Archive evaluation at Screening;&#xD;
&#xD;
         16. Any verified screening Grade 4 laboratory abnormality that in the investigator's&#xD;
             opinion is clinically significant;&#xD;
&#xD;
         17. Moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh&#xD;
             classification;&#xD;
&#xD;
         18. Either of the following liver chemistry elevations:&#xD;
&#xD;
               1. Alanine amintotransferase (ALT) ≥5 x the upper limit of normal (ULN); OR&#xD;
&#xD;
               2. ALT ≥3 x ULN and bilirubin ≥1.5 x ULN (with &gt;35% direct bilirubin);&#xD;
&#xD;
         19. Creatinine clearance (CrCl) of &lt;50 mL/min (calculated by CockroftGault equation)&#xD;
&#xD;
         20. QT interval corrected for heart rate according to Bazett's formula (QTcB) ≥450 msec or&#xD;
             QTcB ≥480 msec for participants with bundle branch block;&#xD;
&#xD;
         21. Any other condition or substance use that in the opinion of the investigator places&#xD;
             the participants at undue risk from participation in the study or that may negatively&#xD;
             impact the integrity of the study analyses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony M Mills, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mills Clinical Research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anthony Mills, MD</last_name>
    <phone>310-550-2271</phone>
    <email>tony.mills@millsclinicalresearch.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ron Knight</last_name>
    <phone>310-550-2271</phone>
    <email>ron.knight@millsclinicalresearch.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mills Clinical Research</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90069</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ron Knight</last_name>
      <phone>310-550-2271</phone>
      <email>ron.knight@millsclinicalresearch.com</email>
    </contact>
    <contact_backup>
      <last_name>Jake Collins</last_name>
      <phone>310-550-2271</phone>
      <email>jake.collins@millsclinicalresearch.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 22, 2016</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mills Clinical Research</investigator_affiliation>
    <investigator_full_name>Anthony Mills MD</investigator_full_name>
    <investigator_title>Clinical Research Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abacavir, dolutegravir, and lamivudine drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </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/NCT03275701
org study id: 205773
nct id: NCT03275701
lead sponsor: 
collaborator: 
has dmc: No
Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected
      Adults ≥50 Years Old Switching from EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild)
      to ABC/DTG/3TC (Triumeq)
Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected
      Adults ≥50 Years Old Switching from EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild)
      to ABC/DTG/3TC (Triumeq)

      To evaluate the impact on BMD, as measured by DEXA over 48 weeks, of switching from an
      INSTI-based regimen with either TDF or TAF to a regimen of ABC/DTG/3TC (administered as
      commercial Triumeq) in chronic HIV-infected patients over the age of 50
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent change from Baseline at Week 48 in total hip BMD (measured by DEXA)
time frame: 48 Weeks
measure: Percent change from Baseline at Week 48 in lumbar spine BMD (measured by DEXA)
time frame: 48 Weeks
measure: Change from Baseline in bone biomarkers for individuals switching to ABC/DTG/3TC
time frame: 96 Weeks
measure: Change from baseline in bone mineral density (in lumbar spine and total hip) assessed by T-scores and Z-scores from Baseline in individuals switching to ABC/DTG/3TC
time frame: 96 Weeks
description: Z-score = (Patient's BMD - expected BMD) / SD; T-score = (BMD-Reference BMD)/SD Units are numerical in value. BMD)/SD Units are numerical in value.
measure: Number of adverse events (including long-term virologic/immunologic responses, abnormal laboratory values, or untoward medical conditions) for individuals switching to ABC/DTG/3TC
time frame: 96 Weeks
arm group label: Triumeq
arm group type: Other
description: Single Arm, Open Label
intervention type: Drug
intervention name: Triumeq
description: Open Label, Switch to Triumeq (ABC/DTG/3TC)
arm group label: Triumeq
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Anthony M Mills, MD
role: Principal Investigator
affiliation: Mills Clinical Research
last name: Anthony Mills, MD
phone: 310-550-2271
email: tony.mills@millsclinicalresearch.com
last name: Ron Knight
phone: 310-550-2271
email: ron.knight@millsclinicalresearch.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mills Clinical Research
investigator full name: Anthony Mills MD
investigator title: Clinical Research Director
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Abacavir, dolutegravir, and lamivudine drug combination
sharing ipd: Yes