<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/NCT02220868</url>
  </required_header>
  <id_info>
    <org_study_id>IN-US-334-1527</org_study_id>
    <nct_id>NCT02220868</nct_id>
  </id_info>
  <brief_title>Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study</brief_title>
  <official_title>Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Michael's Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint Michael's Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the&#xD;
      treatment of hepatitis c in patients taking stribild.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to evaluate the safety, efficacy and pharmacokinetics of&#xD;
      sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in HIV-infected patients on&#xD;
      fixed dose co-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (Stribild).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>Phase 4</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>• SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy</measure>
    <time_frame>12 weeks post treatment</time_frame>
    <description>patients who have achieved non-detectable HCV levels 12 weeks post treatment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Hepatitis C Infection</condition>
  <condition>HIV Infection</condition>
  <arm_group>
    <arm_group_label>Sofossbuvir, Riabvirin, Stribild</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofosbuvir, Ribavirin, and Stribild</intervention_name>
    <arm_group_label>Sofossbuvir, Riabvirin, Stribild</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Chronic HCV genotype 1 infection&#xD;
&#xD;
          -  Receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.&#xD;
&#xD;
          -  CD4 count &gt;200 cells/mm3 at screening and no CD4 count &lt;200 in previous 12 weeks&#xD;
&#xD;
          -  HIV RNA PCR &lt;50 copies/ml at screening and no HIV RNA PCR &gt; 200 copies/ml in previous&#xD;
             12 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of integrase inhibitor resistance&#xD;
&#xD;
          -  History of integrase inhibitor failure&#xD;
&#xD;
          -  Absolute neutrophil counts under 1500/mm3 ( Black/ African Americans &lt;1200/mm3&#xD;
&#xD;
          -  Patients with cirrhosis&#xD;
&#xD;
          -  Platelet count under 90,000 per cubic millimeter&#xD;
&#xD;
          -  Hemoglobin levels &lt;11 gm/dl in women or &lt;12 gm/dl in men&#xD;
&#xD;
          -  Previous treatment with a DAA&#xD;
&#xD;
          -  Hepatocellular carcinoma&#xD;
&#xD;
          -  AFP&gt;100 ng/mL&#xD;
&#xD;
          -  hepatitis B virus (HBsAg positive)&#xD;
&#xD;
          -  Evidence of decompensated liver disease including, but not limited to, a history of&#xD;
             presence of clinical ascites, bleeding varices, or hepatic encephalopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jihad Slim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Michael's Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Michael's Medical Center</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 3, 2016</last_update_submitted>
  <last_update_submitted_qc>August 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint Michael's Medical Center</investigator_affiliation>
    <investigator_full_name>Jihad Slim, MD</investigator_full_name>
    <investigator_title>Chief and Prgram Director, Infectious Diseases</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>HCV</keyword>
  <keyword>DAA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
  </intervention_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/NCT02220868
org study id: IN-US-334-1527
nct id: NCT02220868
lead sponsor: 
has dmc: No
The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the
      treatment of hepatitis c in patients taking stribild.
The objective of this study is to evaluate the safety, efficacy and pharmacokinetics of
      sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in HIV-infected patients on
      fixed dose co-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (Stribild).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: • SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy
time frame: 12 weeks post treatment
description: patients who have achieved non-detectable HCV levels 12 weeks post treatment
arm group label: Sofossbuvir, Riabvirin, Stribild
arm group type: Other
description: Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild
intervention type: Drug
intervention name: Sofosbuvir, Ribavirin, and Stribild
arm group label: Sofossbuvir, Riabvirin, Stribild
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jihad Slim, MD
role: Principal Investigator
affiliation: Saint Michael's Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Saint Michael's Medical Center
investigator full name: Jihad Slim, MD
investigator title: Chief and Prgram Director, Infectious Diseases
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Ribavirin
mesh term: Sofosbuvir
mesh term: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination