<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/NCT03823911</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00081300</org_study_id>
    <nct_id>NCT03823911</nct_id>
  </id_info>
  <brief_title>Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication</brief_title>
  <acronym>CHROME</acronym>
  <official_title>Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an interventional, non-randomized, controlled prospective study to treat HCV in&#xD;
      mono-infected and HIV co-infected individuals and compare cardiovascular risk outcomes to HIV&#xD;
      mono-infected controls. This pilot study will demonstrate whether functional cure of HCV&#xD;
      reduces myocardial injury and risk of cardiovascular disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 18, 2018</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein</measure>
    <time_frame>Baseline to 72 weeks after functional cure of HCV</time_frame>
    <description>Change in high-sensitivity C-reactive protein</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Troponin I and Troponin T From Baseline to After Functional Cure of Hepatitis C</measure>
    <time_frame>Baseline to 48 weeks after functional cure of HCV</time_frame>
    <description>Change in the cardiac biomarkers Troponin I and Troponin T</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Hepatitis C</condition>
  <condition>Hiv</condition>
  <arm_group>
    <arm_group_label>HIV Mono-Infected</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients infected with HIV only, and not currently or previously infected with hepatitis C.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hepatitis C Mono-Infected</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV and Hepatitis C Co-Infected</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elbasvir / Grazoprevir Oral Tablet [Zepatier]</intervention_name>
    <description>All approved direct-acting antivirals for hepatitis C will be used as the intervention.</description>
    <arm_group_label>HIV and Hepatitis C Co-Infected</arm_group_label>
    <arm_group_label>Hepatitis C Mono-Infected</arm_group_label>
    <other_name>Sofosbuvir/Ledipasvir</other_name>
    <other_name>Sofosbuvir/Velpatasvir</other_name>
    <other_name>Glecaprevir/Pibrentasvir</other_name>
    <other_name>Sofosbuvir/Velpatasvir/Voxilaprevir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardiac MRI</intervention_name>
    <description>Cardiac MRI to assess for myocardial function and fibrosis</description>
    <arm_group_label>HIV Mono-Infected</arm_group_label>
    <arm_group_label>HIV and Hepatitis C Co-Infected</arm_group_label>
    <arm_group_label>Hepatitis C Mono-Infected</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; or equal to 18 years old&#xD;
&#xD;
          2. Able and willing to sign informed consent&#xD;
&#xD;
          3. Chronically infected with any HCV genotype (1a, 1b, 2, 3, 4, 5, or 6), defined as any&#xD;
             individual with documentation of positive HCV antibody and positive HCV RNA test (HCV&#xD;
             RNA of 2,000 IU/mL or greater)&#xD;
&#xD;
          4. If HIV+, suppressed on a stable, protocol-approved, ARV regimen for ≥ 8 weeks prior to&#xD;
             starting HCV treatment&#xD;
&#xD;
               1. HIV RNA &lt; 50 copies/mL (or &lt; LLOQ if the local laboratory assay's LLOQ is ≥50&#xD;
                  copies/mL) prior to Screening. Subjects with an isolated or unconfirmed HIV RNA &gt;&#xD;
                  50 copies/mL (or &gt; LLOQ if the local laboratory assay's LLOQ is ≥50 copies/mL)&#xD;
                  are not excluded.&#xD;
&#xD;
               2. CD4 count &gt;100 cells/mm3&#xD;
&#xD;
          5. Willing to have samples stored for future use&#xD;
&#xD;
          6. If tested positive for NS5A resistance-associated polymorphisms or PEG-IFN and&#xD;
             ribavirin experienced, able to tolerate ribavirin-containing regimen for 16 weeks.&#xD;
             Ribavirin will be administered at the discretion of the PI.&#xD;
&#xD;
          7. Women of childbearing potential who receive ribavirin will have to be willing to&#xD;
             commit to abstinence from sexual activity, or use of two forms of contraceptive during&#xD;
             treatment and for the 6 months after completion of ribavirin. Men receiving ribavirin&#xD;
             who are sexually active with women will also have to be willing to commit to&#xD;
             abstinence from sexual activity, or use of two forms of contraceptive during treatment&#xD;
             and for the 6 months after completion of ribavirin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Decompensated liver disease (Childs Pugh B or C)&#xD;
&#xD;
          2. Unable to comply with research study visits&#xD;
&#xD;
          3. Poor venous access not allowing screening laboratory collection&#xD;
&#xD;
          4. Have any condition that the investigator considers a contraindication to study&#xD;
             participation&#xD;
&#xD;
          5. Pregnant or breastfeeding woman&#xD;
&#xD;
          6. Prior HCV treatment with Direct-Acting Antivirals. Note: Patients who are&#xD;
             treatment-experienced with PEG-IFN/RBV will not be excluded; their inclusion in the&#xD;
             study will be considered by the PI.&#xD;
&#xD;
          7. HIV+ patients with prior HCV treatment who achieved sustained virologic response&#xD;
             (SVR)/ functional cure&#xD;
&#xD;
          8. Use of a concomitant medication that is contraindicated with the use of the DAA for&#xD;
             HCV treatment (per package insert)&#xD;
&#xD;
          9. Coinfection with HCV and HBV, in partcular HBsAg + patients.&#xD;
&#xD;
             a. Patients with HBcAb+ will not be excluded, but will have HBV DNA levels checked and&#xD;
             will be monitored while on DAA therapy and medically managed as considered appropriate&#xD;
             by the PI.&#xD;
&#xD;
         10. Have any condition that the investigator considers a contraindication to study&#xD;
             participation or not eligible per standard of care for HCV treatment&#xD;
&#xD;
         11. Patients with the following devices are excluded from participating in the&#xD;
             cardiovascular MRI study:&#xD;
&#xD;
               -  Central nervous system aneurysm clip&#xD;
&#xD;
               -  Implanted neural stimulator&#xD;
&#xD;
               -  Implanted cardiac pacemaker or defibrillator&#xD;
&#xD;
               -  Cochlear implant&#xD;
&#xD;
               -  Ocular foreign body (e.g. metal shavings)&#xD;
&#xD;
               -  Implanted insulin pump&#xD;
&#xD;
               -  Metal shrapnel or bullet&#xD;
&#xD;
         12. The following groups of people are also excluded from participating in the&#xD;
             cardiovascular MRI study:&#xD;
&#xD;
               -  Patients with stable renal disease (estimated glomerular filtration rate&#xD;
                  (eGFR)&lt;30ml/min/1.73m2 body surface area. The eGFR must be within two weeks of&#xD;
                  the the MRI exam.&#xD;
&#xD;
               -  Patients with acute renal disease.&#xD;
&#xD;
         13. Patients who choose to have the cardiac MRI and are over 60 years of age, have a&#xD;
             history of renal failure, or have type I or II diabetes mellitus must have laboratory&#xD;
             tests the same day as the MRI exam.&#xD;
&#xD;
         14. Positive urine drug screen at screening. Not all patients with positive drug screen&#xD;
             will be excluded; decision will be made by the PI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Poonam Mathur, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, Baltimore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unity Parkside Health Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Human Virology, CRU</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <results_first_submitted>April 25, 2023</results_first_submitted>
  <results_first_submitted_qc>May 19, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 22, 2023</results_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Poonam Mathur</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cardiovascular Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Grazoprevir</mesh_term>
    <mesh_term>Ledipasvir</mesh_term>
    <mesh_term>Velpatasvir</mesh_term>
    <mesh_term>Elbasvir-grazoprevir drug combination</mesh_term>
    <mesh_term>Sofosbuvir-velpatasvir drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Stored samples will be sent to the Institute of Human Virology at the University of Maryland and to BHF Centre for Cardiovascular Sciences:&#xD;
Individuals with new seroconversion to HIV will have samples sent for viral sequencing and phylogenetic analysis. Individuals with detectable HCV RNA after completion of HCV treatment or new infection during the follow up period will have current sample, and baseline stored sample sent for viral sequencing and phylogenetic analysis.&#xD;
In addition, we will study the viral and host immunity to HCV and HIV in all patients. The results will be used to characterize each individual with regards to immune status and chronicity of disease.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03823911/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>HIV Mono-Infected</title>
          <description>Patients infected with HIV only, and not currently or previously infected with hepatitis C.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
        </group>
        <group group_id="P2">
          <title>Hepatitis C Mono-Infected</title>
          <description>Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection&#xD;
Elbasvir / Grazoprevir Oral Tablet [Zepatier]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
        </group>
        <group group_id="P3">
          <title>HIV and Hepatitis C Co-Infected</title>
          <description>Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.&#xD;
Elbasvir / Grazoprevir Oral Tablet [Zepatier]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>HIV Mono-Infected</title>
          <description>Patients infected with HIV only, and not currently or previously infected with hepatitis C.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
        </group>
        <group group_id="B2">
          <title>Hepatitis C Mono-Infected</title>
          <description>Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection&#xD;
Elbasvir / Grazoprevir Oral Tablet [Zepatier]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
        </group>
        <group group_id="B3">
          <title>HIV and Hepatitis C Co-Infected</title>
          <description>Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.&#xD;
Elbasvir / Grazoprevir Oral Tablet [Zepatier]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
            <count group_id="B2" value="37"/>
            <count group_id="B3" value="7"/>
            <count group_id="B4" value="87"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" lower_limit="28" upper_limit="78"/>
                    <measurement group_id="B2" value="58" lower_limit="26" upper_limit="71"/>
                    <measurement group_id="B3" value="56" lower_limit="34" upper_limit="67"/>
                    <measurement group_id="B4" value="55" lower_limit="26" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein</title>
        <description>Change in high-sensitivity C-reactive protein</description>
        <time_frame>Baseline to 72 weeks after functional cure of HCV</time_frame>
        <population>13 participants were analyzed in the hepatitis C mono-infected group and 1 participant in the HIV-HCV co-infected group since other participants were lost to follow-up and week 72 data was available for these participants only.</population>
        <group_list>
          <group group_id="O1">
            <title>Hepatitis C Mono-Infected</title>
            <description>Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection&#xD;
Elbasvir / Grazoprevir Oral Tablet [Zepatier]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
          </group>
          <group group_id="O2">
            <title>HIV and Hepatitis C Co-Infected</title>
            <description>Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.&#xD;
Elbasvir / Grazoprevir Oral Tablet [Zepatier]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein</title>
          <description>Change in high-sensitivity C-reactive protein</description>
          <population>13 participants were analyzed in the hepatitis C mono-infected group and 1 participant in the HIV-HCV co-infected group since other participants were lost to follow-up and week 72 data was available for these participants only.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.96"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Troponin I and Troponin T From Baseline to After Functional Cure of Hepatitis C</title>
        <description>Change in the cardiac biomarkers Troponin I and Troponin T</description>
        <time_frame>Baseline to 48 weeks after functional cure of HCV</time_frame>
        <population>Data on troponin I and T were not collected for any of the participants, therefore the outcome cannot be reported</population>
        <group_list>
          <group group_id="O1">
            <title>Hepatitis C Mono-Infected</title>
            <description>Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection&#xD;
Elbasvir / Grazoprevir Oral Tablet [Zepatier]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
          </group>
          <group group_id="O2">
            <title>HIV and Hepatitis C Co-Infected</title>
            <description>Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.&#xD;
Elbasvir / Grazoprevir Oral Tablet [Zepatier]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Troponin I and Troponin T From Baseline to After Functional Cure of Hepatitis C</title>
          <description>Change in the cardiac biomarkers Troponin I and Troponin T</description>
          <population>Data on troponin I and T were not collected for any of the participants, therefore the outcome cannot be reported</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected over 12 weeks while on hepatitis C therapy</time_frame>
      <group_list>
        <group group_id="E1">
          <title>HIV Mono-Infected</title>
          <description>Patients infected with HIV only, and not currently or previously infected with hepatitis C.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
        </group>
        <group group_id="E2">
          <title>Hepatitis C Mono-Infected</title>
          <description>Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection&#xD;
Elbasvir / Grazoprevir Oral Tablet [Zepatier]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
        </group>
        <group group_id="E3">
          <title>HIV and Hepatitis C Co-Infected</title>
          <description>Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.&#xD;
Elbasvir / Grazoprevir Oral Tablet [Zepatier]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.&#xD;
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Poonam Mathur</name_or_title>
      <organization>Institute of Human Virology, University of Maryland School of Medicine</organization>
      <phone>410-706-4745</phone>
      <email>pmathur@ihv.umaryland.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03823911
org study id: HP-00081300
nct id: NCT03823911
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: No
This is an interventional, non-randomized, controlled prospective study to treat HCV in
      mono-infected and HIV co-infected individuals and compare cardiovascular risk outcomes to HIV
      mono-infected controls. This pilot study will demonstrate whether functional cure of HCV
      reduces myocardial injury and risk of cardiovascular disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein
time frame: Baseline to 72 weeks after functional cure of HCV
description: Change in high-sensitivity C-reactive protein
measure: Change in Troponin I and Troponin T From Baseline to After Functional Cure of Hepatitis C
time frame: Baseline to 48 weeks after functional cure of HCV
description: Change in the cardiac biomarkers Troponin I and Troponin T
arm group label: HIV Mono-Infected
arm group type: Active Comparator
description: Patients infected with HIV only, and not currently or previously infected with hepatitis C.
arm group label: Hepatitis C Mono-Infected
arm group type: Experimental
description: Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection
arm group label: HIV and Hepatitis C Co-Infected
arm group type: Experimental
description: Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.
intervention type: Drug
intervention name: Elbasvir / Grazoprevir Oral Tablet [Zepatier]
description: All approved direct-acting antivirals for hepatitis C will be used as the intervention.
arm group label: HIV and Hepatitis C Co-Infected
arm group label: Hepatitis C Mono-Infected
other name: Sofosbuvir/Ledipasvir
other name: Sofosbuvir/Velpatasvir
other name: Glecaprevir/Pibrentasvir
other name: Sofosbuvir/Velpatasvir/Voxilaprevir
intervention type: Procedure
intervention name: Cardiac MRI
description: Cardiac MRI to assess for myocardial function and fibrosis
arm group label: HIV Mono-Infected
arm group label: HIV and Hepatitis C Co-Infected
arm group label: Hepatitis C Mono-Infected
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Poonam Mathur, DO
role: Principal Investigator
affiliation: University of Maryland, Baltimore
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Poonam Mathur
investigator title: Assistant Professor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Cardiovascular Diseases
mesh term: Sofosbuvir
mesh term: Grazoprevir
mesh term: Ledipasvir
mesh term: Velpatasvir
mesh term: Elbasvir-grazoprevir drug combination
mesh term: Sofosbuvir-velpatasvir drug combination
sharing ipd: Yes
ipd description: Stored samples will be sent to the Institute of Human Virology at the University of Maryland and to BHF Centre for Cardiovascular Sciences:
Individuals with new seroconversion to HIV will have samples sent for viral sequencing and phylogenetic analysis. Individuals with detectable HCV RNA after completion of HCV treatment or new infection during the follow up period will have current sample, and baseline stored sample sent for viral sequencing and phylogenetic analysis.
In addition, we will study the viral and host immunity to HCV and HIV in all patients. The results will be used to characterize each individual with regards to immune status and chronicity of disease.
ipd info type: Study Protocol
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 