<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/NCT03037372</url>
  </required_header>
  <id_info>
    <org_study_id>DN2017</org_study_id>
    <nct_id>NCT03037372</nct_id>
  </id_info>
  <brief_title>Statin Adjunct Therapy Among ART-treated Adults in Sub-Saharan Africa: Atorvastatin and Rosuvastatin Equivalence Trial</brief_title>
  <acronym>STAR</acronym>
  <official_title>Statin Adjunct Therapy Among HAART-treated Adults in Sub-Saharan Africa: Equivalence of Atorvastatin and Rosuvastatin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Makerere University</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>
      This study will determine whether 36 months of daily atorvastatin or rosuvastatin have&#xD;
      equivalent effects in reduction of immune activation, inflammation and immune aging, when&#xD;
      given as adjunct therapy among patients receiving antiretroviral therapy in an African cohort&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, open-label trial&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <phase>Phase 3</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>Similar rate of reduction of immune activation between atorvastatin and rosuvastatin arms (p&lt;o.05)</measure>
    <time_frame>12 months</time_frame>
    <description>measured by percentage of HLADR+CD38+T-cells</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Similar rate of change of immune aging markers, between ART-treated adults with and without statin (atorvastatin and rosuvastatin) adjunct therapy arms (P-value&lt;0.05)</measure>
    <time_frame>36 months</time_frame>
    <description>Measured by Percentage of CD4+ and CD8+ naive T-cells or percentage of expressing Ki67 T-cells or percentage of low CFSE+T-cells or increase in percentage of CD28-/CD57+ T-cells or percentage of individuals with low host responses to influenza vaccine among HIV-infected adults at ART initiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Similar rate of reduction of inflammatory markers, between atorvastatin and rosuvastatin arms (p&lt;0.05)</measure>
    <time_frame>36 months</time_frame>
    <description>Measured by levels of IL6 in pg/ml, hsCRP in pg/ml, d-dimers in pg/ml, IFABP in pg/ml, and LPS in pg/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological pathways affected by atorvastatin and rosuvastatin</measure>
    <time_frame>36 months</time_frame>
    <description>number of genes down-regulated by either atorvastatin or rosuvastatin</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>HIV Infection</condition>
  <arm_group>
    <arm_group_label>ART-Atorvastatin adjunct therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ART, atorvastatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ART-Rosuvastatin adjunct therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ART, rosuvastatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ART-without statin adjunct therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ART, no statin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy-HIV-negative</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Age-matched HIV-negative, healthy volunteers from the same community</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ART, Atorvastatin</intervention_name>
    <description>ART, Atorvastatin</description>
    <arm_group_label>ART-Atorvastatin adjunct therapy</arm_group_label>
    <other_name>Atovastatin adjunct therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ART, Rosuvastatin</intervention_name>
    <description>ART, Rosuvastatin</description>
    <arm_group_label>ART-Rosuvastatin adjunct therapy</arm_group_label>
    <other_name>Rosuvastatin adjunct therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ART, No statin</intervention_name>
    <description>ART, No statin</description>
    <arm_group_label>ART-without statin adjunct therapy</arm_group_label>
    <other_name>No statin adjunct therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Healthy-HIV-negative</intervention_name>
    <description>Age-matched, Healthy HIV-negative</description>
    <arm_group_label>Healthy-HIV-negative</arm_group_label>
    <other_name>HIV-negative controls</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-positive individuals 18 years and older, that have initiated three first-line drug&#xD;
             highly active antiretroviral therapy within three months within the Infectious&#xD;
             Diseases Institute HIV treatment cohort&#xD;
&#xD;
          -  Individuals that provide written informed consent to participate in the clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Individuals with dyslipidemia and eligible to receive or already receiving statin therapy&#xD;
&#xD;
          -  Pregnant or lactating mothers&#xD;
&#xD;
          -  Individuals with another active or controlled inflammatory condition&#xD;
&#xD;
          -  Individuals with deranged liver function tests 3 fold and above&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Damalie Nakanjako, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makerere University College of Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Damalie Nakanjako, PhD</last_name>
    <phone>+256772411273</phone>
    <email>dnakanjako@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rose Nabatanzo, MSC</last_name>
    <phone>+256772603646</phone>
    <email>rosemagala@gmail.com</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Funderburg NT, Jiang Y, Debanne SM, Labbato D, Juchnowski S, Ferrari B, Clagett B, Robinson J, Lederman MM, McComsey GA. Rosuvastatin reduces vascular inflammation and T-cell and monocyte activation in HIV-infected subjects on antiretroviral therapy. J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):396-404. doi: 10.1097/QAI.0000000000000478.</citation>
    <PMID>25514794</PMID>
  </results_reference>
  <results_reference>
    <citation>Nakanjako D, Ssinabulya I, Nabatanzi R, Bayigga L, Kiragga A, Joloba M, Kaleebu P, Kambugu AD, Kamya MR, Sekaly R, Elliott A, Mayanja-Kizza H. Atorvastatin reduces T-cell activation and exhaustion among HIV-infected cART-treated suboptimal immune responders in Uganda: a randomised crossover placebo-controlled trial. Trop Med Int Health. 2015 Mar;20(3):380-90. doi: 10.1111/tmi.12442. Epub 2015 Jan 6.</citation>
    <PMID>25441397</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adults</keyword>
  <keyword>antiretroviral therapy</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>Atorvastatin</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
    <mesh_term>Hydroxymethylglutaryl-CoA Reductase Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared with the Infectious Diseases Institute, according to the IDI data sharing policy</ipd_description>
  </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/NCT03037372
org study id: DN2017
nct id: NCT03037372
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will determine whether 36 months of daily atorvastatin or rosuvastatin have
      equivalent effects in reduction of immune activation, inflammation and immune aging, when
      given as adjunct therapy among patients receiving antiretroviral therapy in an African cohort
This is a randomized, open-label trial
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Similar rate of reduction of immune activation between atorvastatin and rosuvastatin arms (p<o.05)
time frame: 12 months
description: measured by percentage of HLADR+CD38+T-cells
measure: Similar rate of change of immune aging markers, between ART-treated adults with and without statin (atorvastatin and rosuvastatin) adjunct therapy arms (P-value<0.05)
time frame: 36 months
description: Measured by Percentage of CD4+ and CD8+ naive T-cells or percentage of expressing Ki67 T-cells or percentage of low CFSE+T-cells or increase in percentage of CD28-/CD57+ T-cells or percentage of individuals with low host responses to influenza vaccine among HIV-infected adults at ART initiation
measure: Similar rate of reduction of inflammatory markers, between atorvastatin and rosuvastatin arms (p<0.05)
time frame: 36 months
description: Measured by levels of IL6 in pg/ml, hsCRP in pg/ml, d-dimers in pg/ml, IFABP in pg/ml, and LPS in pg/ml
measure: Biological pathways affected by atorvastatin and rosuvastatin
time frame: 36 months
description: number of genes down-regulated by either atorvastatin or rosuvastatin
arm group label: ART-Atorvastatin adjunct therapy
arm group type: Experimental
description: ART, atorvastatin
arm group label: ART-Rosuvastatin adjunct therapy
arm group type: Experimental
description: ART, rosuvastatin
arm group label: ART-without statin adjunct therapy
arm group type: Experimental
description: ART, no statin
arm group label: Healthy-HIV-negative
arm group type: Experimental
description: Age-matched HIV-negative, healthy volunteers from the same community
intervention type: Drug
intervention name: ART, Atorvastatin
description: ART, Atorvastatin
arm group label: ART-Atorvastatin adjunct therapy
other name: Atovastatin adjunct therapy
intervention type: Drug
intervention name: ART, Rosuvastatin
description: ART, Rosuvastatin
arm group label: ART-Rosuvastatin adjunct therapy
other name: Rosuvastatin adjunct therapy
intervention type: Drug
intervention name: ART, No statin
description: ART, No statin
arm group label: ART-without statin adjunct therapy
other name: No statin adjunct therapy
intervention type: Drug
intervention name: Healthy-HIV-negative
description: Age-matched, Healthy HIV-negative
arm group label: Healthy-HIV-negative
other name: HIV-negative controls
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Damalie Nakanjako, PhD
role: Principal Investigator
affiliation: Makerere University College of Health Sciences
last name: Damalie Nakanjako, PhD
phone: +256772411273
email: dnakanjako@gmail.com
last name: Rose Nabatanzo, MSC
phone: +256772603646
email: rosemagala@gmail.com
citation: Funderburg NT, Jiang Y, Debanne SM, Labbato D, Juchnowski S, Ferrari B, Clagett B, Robinson J, Lederman MM, McComsey GA. Rosuvastatin reduces vascular inflammation and T-cell and monocyte activation in HIV-infected subjects on antiretroviral therapy. J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):396-404. doi: 10.1097/QAI.0000000000000478.
PMID: 25514794
citation: Nakanjako D, Ssinabulya I, Nabatanzi R, Bayigga L, Kiragga A, Joloba M, Kaleebu P, Kambugu AD, Kamya MR, Sekaly R, Elliott A, Mayanja-Kizza H. Atorvastatin reduces T-cell activation and exhaustion among HIV-infected cART-treated suboptimal immune responders in Uganda: a randomised crossover placebo-controlled trial. Trop Med Int Health. 2015 Mar;20(3):380-90. doi: 10.1111/tmi.12442. Epub 2015 Jan 6.
PMID: 25441397
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Atorvastatin
mesh term: Rosuvastatin Calcium
mesh term: Hydroxymethylglutaryl-CoA Reductase Inhibitors
sharing ipd: Yes
ipd description: Data will be shared with the Infectious Diseases Institute, according to the IDI data sharing policy