<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/NCT01705873</url>
  </required_header>
  <id_info>
    <org_study_id>ANV-10-0165</org_study_id>
    <nct_id>NCT01705873</nct_id>
  </id_info>
  <brief_title>Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen</brief_title>
  <official_title>Retrospective Analysis on the Risk of Cardiovascular (CV) Events in HIV- Infected Subjects From Latin America Treated With a Lopinavir/Ritonavir (LPV/r) Based HAART Regimen vs. an Efavirenz (EFV) Based HAART Regimen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helios Salud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Helios Salud</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate changes in Framingham score (from low to moderate,&#xD;
      from moderate to high) based on changes in lipid profile and other parameters from baseline&#xD;
      to 48 weeks of HAART in naïve patients or patients in second line of treatment, considering&#xD;
      LPV/r vs EFV based HAART. The null hyphotesis is that there is an increased Framingham score&#xD;
      in patients treated with LPV/r as second line treatment and in patients treated with LPV/r or&#xD;
      EFV regimen as first line treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design and duration: Retrospective comparative study. Estimated time of enrollment: 12&#xD;
      months.&#xD;
&#xD;
      Procedure: Retrospective review of clinical charts: LPV/r (n = 100) and EFV (a randomly&#xD;
      selected representative sample of patients under EFV treatment: 200 patients approximately.).&#xD;
      Each patient can only be included in one arm of the study (cannot switch EFV to LPV/r or from&#xD;
      LPV/r to EFV)&#xD;
&#xD;
      Subject population&#xD;
&#xD;
      LPV/r (n = 100) and EFV (a randomly selected representative sample of patients under EFV&#xD;
      treatment: 200 patients approximately.). Each patient can only be included in one arm of the&#xD;
      study (cannot switch EFV to LPV/r or from LPV/r to EFV)&#xD;
&#xD;
      Study Objectives:&#xD;
&#xD;
      Primary Objectives&#xD;
&#xD;
      1)Changes in Framingham score (from low to moderate, from moderate to high) based on changes&#xD;
      in lipid profile and other parameters from baseline to 48 weeks of HAART in naïve patients or&#xD;
      patients in second line of treatment Secondary Objectives&#xD;
&#xD;
        1. Risk assessment hazard of CV events in HIV- infected subjects treated with a LPV/r as&#xD;
           second line and EFV and LPV/r first line based HAART regimen in the whole population&#xD;
           under study and in the female and male subpopulations.&#xD;
&#xD;
        2. Assessment for 10- year risk of developing hard cardiovascular events (myocardial&#xD;
           infarction and coronary death) in HIV- infected subjects treated with a LPV/r ( 1° o 2°&#xD;
           line) and EFV first line based HAART regimen&#xD;
&#xD;
        3. Overall mortality (including CV events) in HIV- infected subjects treated with a LPV/r&#xD;
           as second line and EFV and LPV/r first line based HAART regimen&#xD;
&#xD;
        4. Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid&#xD;
           lowering agents requirement: baseline vs. 48 weeks after the initiation of a LPV/r&#xD;
           second line based HAART regimen and those on an LPV/r and EFV first line based HAART&#xD;
           regimen&#xD;
&#xD;
        5. Assesment of CD4 T-cell count and viral load at baseline and at 48 weeks in each&#xD;
           regimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Anticipated">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Risk for CV events</measure>
    <time_frame>Per year</time_frame>
    <description>Changes in Framingham risk for CV events (from low to moderate, from moderate to high) based on changes in lipid parameters from baseline at 6, 12, Q12 months after the initiation of a LPV/r based HAART regimen in the whole population under study.Participants will be followed for an average of 24 months .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risk for CV events</measure>
    <time_frame>Per year</time_frame>
    <description>Changes in Framingham risk for CV events (from low to moderate, from moderate to high) based on changes in lipid parameters from baseline at 6, 12, Q12 months after the initiation of a LPV/r based HAART regimen in male subpopulation.Participants will be followed for an average of 24 months .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risk for CV events</measure>
    <time_frame>Per year</time_frame>
    <description>Changes in Framingham risk for CV events (from low to moderate, from moderate to high) based on changes in lipid parameters from baseline at 6, 12, Q12 months after the initiation of a LPV/r based HAART regimen in female subpopulation. Participants will be followed for an average of 24 months .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>Per year</time_frame>
    <description>Overall mortality (including CV events) in HIV- infected subjects treated with a LPV/r as second line and EFV and LPV/r first line based HAART regimen in the whole population under study. Participants will be followed for an average of 24 months .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>Per year</time_frame>
    <description>Overall mortality (including CV events) in HIV- infected subjects treated with a LPV/r as second line and EFV and LPV/r first line based HAART regimen in male subpopulation.Participants will be followed for an average of 24 months .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>Per year</time_frame>
    <description>Overall mortality (including CV events) in HIV- infected subjects treated with a LPV/r as second line and EFV and LPV/r first line based HAART regimen in female subpopulation. Participants will be followed for an average of 24 months .</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Evolution of lipid profile</measure>
    <time_frame>Per year</time_frame>
    <description>Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid lowering agents requirement from baseline at 6, 12, Q12 months after the initiation of a LPV/r second line based HAART regimen and those on an LPV/r or EFV first line based HAART regimen in the whole population under study. Participants will be followed for an average of 24 months .</description>
  </other_outcome>
  <other_outcome>
    <measure>Evolution of lipid profile</measure>
    <time_frame>Per year</time_frame>
    <description>Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid lowering agents requirement from baseline at 6, 12, Q12 months after the initiation of a LPV/r second line based HAART regimen and those on an LPV/r or EFV first line based HAART regimen in male subpopulation. Participants will be followed for an average of 24 months .</description>
  </other_outcome>
  <other_outcome>
    <measure>Evolution of lipid profile</measure>
    <time_frame>Per year</time_frame>
    <description>Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid lowering agents requirement from baseline at 6, 12, Q12 months after the initiation of a LPV/r second line based HAART regimen and those on an LPV/r or EFV first line based HAART regimen in female subpopulation. Participants will be followed for an average of 24 months .</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>HIV</condition>
  <condition>Hypercholesterolemia</condition>
  <condition>Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>LPV/r</arm_group_label>
    <description>LPV/r based HAART</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Efavirenz</arm_group_label>
    <description>EFV first line based HAART</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        HIV-infected patients with first line HAART with EFV or LPV/r or second line HAART with&#xD;
        LPV/r&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. HIV positive patients (confirmation with ELISA + W. blot required).&#xD;
&#xD;
          2. Age ≥ 18 years.&#xD;
&#xD;
          3. Naïve or experienced with antiretroviral drugs.&#xD;
&#xD;
          4. LPV/r or EFV as first line regimen.&#xD;
&#xD;
          5. In patients with a LPV/r second line HAART regimen, prior exposure to any NNRTI&#xD;
             regimen is acceptable.&#xD;
&#xD;
          6. Time of exposure to LPV/r or EFV of at least 48 weeks.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Age &lt; 18 yrs.&#xD;
&#xD;
          2. Already LPV/r treatment at admission in our institution (that prevents assessment of&#xD;
             baseline lipid profile and CV risk when patient receives the &quot;first dose&quot; of either&#xD;
             LPV/r )&#xD;
&#xD;
          3. Patients that had received LPV/r only during they pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lidia I Cassetti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helios Salud</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Diego M Cecchini, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Helios Salud</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helios Salud</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1141</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diego M Cecchini, PhD</last_name>
      <phone>54 11 4896 1868</phone>
      <phone_ext>116</phone_ext>
      <email>dcecchini@heliossalud.com.ar</email>
    </contact>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 11, 2012</last_update_submitted>
  <last_update_submitted_qc>October 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helios Salud</investigator_affiliation>
    <investigator_full_name>Isabel Cassetti</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>cardiovascular</keyword>
  <keyword>risk</keyword>
  <keyword>mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <!-- 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/NCT01705873
org study id: ANV-10-0165
nct id: NCT01705873
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to evaluate changes in Framingham score (from low to moderate,
      from moderate to high) based on changes in lipid profile and other parameters from baseline
      to 48 weeks of HAART in naïve patients or patients in second line of treatment, considering
      LPV/r vs EFV based HAART. The null hyphotesis is that there is an increased Framingham score
      in patients treated with LPV/r as second line treatment and in patients treated with LPV/r or
      EFV regimen as first line treatments.
Study design and duration: Retrospective comparative study. Estimated time of enrollment: 12
      months.

      Procedure: Retrospective review of clinical charts: LPV/r (n = 100) and EFV (a randomly
      selected representative sample of patients under EFV treatment: 200 patients approximately.).
      Each patient can only be included in one arm of the study (cannot switch EFV to LPV/r or from
      LPV/r to EFV)

      Subject population

      LPV/r (n = 100) and EFV (a randomly selected representative sample of patients under EFV
      treatment: 200 patients approximately.). Each patient can only be included in one arm of the
      study (cannot switch EFV to LPV/r or from LPV/r to EFV)

      Study Objectives:

      Primary Objectives

      1)Changes in Framingham score (from low to moderate, from moderate to high) based on changes
      in lipid profile and other parameters from baseline to 48 weeks of HAART in naïve patients or
      patients in second line of treatment Secondary Objectives

        1. Risk assessment hazard of CV events in HIV- infected subjects treated with a LPV/r as
           second line and EFV and LPV/r first line based HAART regimen in the whole population
           under study and in the female and male subpopulations.

        2. Assessment for 10- year risk of developing hard cardiovascular events (myocardial
           infarction and coronary death) in HIV- infected subjects treated with a LPV/r ( 1° o 2°
           line) and EFV first line based HAART regimen

        3. Overall mortality (including CV events) in HIV- infected subjects treated with a LPV/r
           as second line and EFV and LPV/r first line based HAART regimen

        4. Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid
           lowering agents requirement: baseline vs. 48 weeks after the initiation of a LPV/r
           second line based HAART regimen and those on an LPV/r and EFV first line based HAART
           regimen

        5. Assesment of CD4 T-cell count and viral load at baseline and at 48 weeks in each
           regimen.
observational model: Cohort
time perspective: Retrospective
measure: Risk for CV events
time frame: Per year
description: Changes in Framingham risk for CV events (from low to moderate, from moderate to high) based on changes in lipid parameters from baseline at 6, 12, Q12 months after the initiation of a LPV/r based HAART regimen in the whole population under study.Participants will be followed for an average of 24 months .
measure: Risk for CV events
time frame: Per year
description: Changes in Framingham risk for CV events (from low to moderate, from moderate to high) based on changes in lipid parameters from baseline at 6, 12, Q12 months after the initiation of a LPV/r based HAART regimen in male subpopulation.Participants will be followed for an average of 24 months .
measure: Risk for CV events
time frame: Per year
description: Changes in Framingham risk for CV events (from low to moderate, from moderate to high) based on changes in lipid parameters from baseline at 6, 12, Q12 months after the initiation of a LPV/r based HAART regimen in female subpopulation. Participants will be followed for an average of 24 months .
measure: All cause mortality
time frame: Per year
description: Overall mortality (including CV events) in HIV- infected subjects treated with a LPV/r as second line and EFV and LPV/r first line based HAART regimen in the whole population under study. Participants will be followed for an average of 24 months .
measure: All cause mortality
time frame: Per year
description: Overall mortality (including CV events) in HIV- infected subjects treated with a LPV/r as second line and EFV and LPV/r first line based HAART regimen in male subpopulation.Participants will be followed for an average of 24 months .
measure: All cause mortality
time frame: Per year
description: Overall mortality (including CV events) in HIV- infected subjects treated with a LPV/r as second line and EFV and LPV/r first line based HAART regimen in female subpopulation. Participants will be followed for an average of 24 months .
measure: Evolution of lipid profile
time frame: Per year
description: Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid lowering agents requirement from baseline at 6, 12, Q12 months after the initiation of a LPV/r second line based HAART regimen and those on an LPV/r or EFV first line based HAART regimen in the whole population under study. Participants will be followed for an average of 24 months .
measure: Evolution of lipid profile
time frame: Per year
description: Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid lowering agents requirement from baseline at 6, 12, Q12 months after the initiation of a LPV/r second line based HAART regimen and those on an LPV/r or EFV first line based HAART regimen in male subpopulation. Participants will be followed for an average of 24 months .
measure: Evolution of lipid profile
time frame: Per year
description: Evolution of lipid profile (total cholesterol, HDL, LDL and triglicerides) and lipid lowering agents requirement from baseline at 6, 12, Q12 months after the initiation of a LPV/r second line based HAART regimen and those on an LPV/r or EFV first line based HAART regimen in female subpopulation. Participants will be followed for an average of 24 months .
arm group label: LPV/r
description: LPV/r based HAART
arm group label: Efavirenz
description: EFV first line based HAART
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lidia I Cassetti, MD
role: Principal Investigator
affiliation: Helios Salud
last name: Diego M Cecchini, PhD
role: Study Chair
affiliation: Helios Salud
facility: 
status: Recruiting
contact: 
country: Argentina
responsible party type: Principal Investigator
investigator affiliation: Helios Salud
investigator full name: Isabel Cassetti
investigator title: MD
mesh term: Hypercholesterolemia
mesh term: Dyslipidemias