<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/NCT01684787</url>
  </required_header>
  <id_info>
    <org_study_id>Miguel Santín</org_study_id>
    <nct_id>NCT01684787</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients</brief_title>
  <acronym>CONTRA</acronym>
  <official_title>Open Multicentre, Phase IV Study to Evaluate Efficacy and Safety of Pegylated Interferon Alpha-2a (40 KD) Plus Ribavirin for Chronic Hepatitis C With Normal Transaminases in Human Immunodeficiency Virus-infected Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miguel Santin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari de Bellvitge</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the current practice patients with normal levels of ALT were not treated. However, a&#xD;
      percentage of patients will present an advanced grade of fibrosis and cirrhosis.&#xD;
&#xD;
      Another reason to treat is the similar response to the treatment than elevated ALT patients&#xD;
      published recently in mono-infected patients.&#xD;
&#xD;
      The investigators have not data concerning the evolution and response to the treatment in&#xD;
      co-infected patients with normal ALT.&#xD;
&#xD;
      In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it&#xD;
      assumes a behavior similar between mono and co-infected patients and the results are&#xD;
      different.&#xD;
&#xD;
      In the case of normal ALT the investigators do not know if the natural history in co-infected&#xD;
      patients is similar than the mono-infected patients, and also the response of the treatment.&#xD;
&#xD;
      This study prospective and controls is the answer of this question. The main hypothesis is if&#xD;
      the response of treatment in co-infected patients is not inferior than mono-infected&#xD;
      patients.&#xD;
&#xD;
      The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin&#xD;
      in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE&#xD;
      (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning&#xD;
      genotype, gender and hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment of co-infected patients with normal ALT would be very important because the&#xD;
      evolution of cirrhosis in this patients is quicker and frequently than mono-infected&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2006</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">May 2011</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% patients with RNA-HCV negative</measure>
    <time_frame>24 weeks after treatment</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peginterferon alfa-2a + ribavirin in normal ALT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>peginterferon alfa-2a + ribavirin in elevated ALT</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peginterferon alfa-2a + ribavirin in normal ALT</intervention_name>
    <description>peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily</description>
    <arm_group_label>1</arm_group_label>
    <other_name>Pegasys + ribavirin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peginterferon alfa-2a + ribavirin in elevated ALT</intervention_name>
    <description>peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily</description>
    <arm_group_label>2</arm_group_label>
    <other_name>Pegasys + ribavirin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years old&#xD;
&#xD;
          -  Hepatitis C co infected with stable HIV-1 and normal ALT (CASE) or elevated levels of&#xD;
             ALT (CONTROL)&#xD;
&#xD;
          -  CD4 &gt; 200 cel/mL&#xD;
&#xD;
          -  Stable anti-retroviral treatment for HIV during at least, the 6 previous months to the&#xD;
             inclusion&#xD;
&#xD;
          -  Negative contraception test&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any previous treatment for CHC&#xD;
&#xD;
          -  Any experimental treatment in the 6 previous weeks to the inclusion&#xD;
&#xD;
          -  Cirrhosis grade B or C (Child-Pugh)&#xD;
&#xD;
          -  Treatment with colony-stimulating factors, didanosine or zidovudine, immunomodulator&#xD;
             therapy, isoniazid, rifampicin, …&#xD;
&#xD;
          -  Hepatic cancer&#xD;
&#xD;
          -  Neutrophils &lt; 1500 cel/mL, Platelets &lt; 70000 cel/mL, Hemoglobin &lt; 11 g/dL (men) or &lt;&#xD;
             12 g/dL (women) previous to inclusion&#xD;
&#xD;
          -  Severe psychiatric illness background&#xD;
&#xD;
          -  Serum creatinin &gt; 1,5 times the upper normal limit&#xD;
&#xD;
          -  Background of Pulmonary or Cardiovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miguel Santin, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Universitari of Bellvitge</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Txagorritxu</name>
      <address>
        <city>Vitoria</city>
        <state>Alava</state>
        <zip>01009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consorci Sanitari Integral</name>
      <address>
        <city>Hospitalet</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari of Bellvitge</name>
      <address>
        <city>Hospitalet</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Mataró</name>
      <address>
        <city>Mataró</city>
        <state>Barcelona</state>
        <zip>08304</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consorci Sanitari de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona</state>
        <zip>08227</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Donostia</name>
      <address>
        <city>San Sebastián</city>
        <state>Guipúzcoa</state>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Xeral-Cíes</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36204</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cruces</name>
      <address>
        <city>Baracaldo</city>
        <state>Vizcaya</state>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Jorge</name>
      <address>
        <city>Huesca</city>
        <zip>22004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Joan XXIII</name>
      <address>
        <city>Tarragona</city>
        <zip>43007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>June 11, 2010</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 12, 2012</last_update_submitted>
  <last_update_submitted_qc>September 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitari de Bellvitge</investigator_affiliation>
    <investigator_full_name>Miguel Santin</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>chronic hepatitis C</keyword>
  <keyword>normal ALT</keyword>
  <keyword>HIV/HCV patients</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 C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Peginterferon alfa-2a</mesh_term>
    <mesh_term>Interferon-alpha</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/NCT01684787
org study id: Miguel Santín
nct id: NCT01684787
lead sponsor: 
has dmc: Yes
In the current practice patients with normal levels of ALT were not treated. However, a
      percentage of patients will present an advanced grade of fibrosis and cirrhosis.

      Another reason to treat is the similar response to the treatment than elevated ALT patients
      published recently in mono-infected patients.

      The investigators have not data concerning the evolution and response to the treatment in
      co-infected patients with normal ALT.

      In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it
      assumes a behavior similar between mono and co-infected patients and the results are
      different.

      In the case of normal ALT the investigators do not know if the natural history in co-infected
      patients is similar than the mono-infected patients, and also the response of the treatment.

      This study prospective and controls is the answer of this question. The main hypothesis is if
      the response of treatment in co-infected patients is not inferior than mono-infected
      patients.

      The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin
      in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE
      (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning
      genotype, gender and hospital.
The treatment of co-infected patients with normal ALT would be very important because the
      evolution of cirrhosis in this patients is quicker and frequently than mono-infected
      patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: % patients with RNA-HCV negative
time frame: 24 weeks after treatment
arm group label: 1
arm group type: Experimental
description: Peginterferon alfa-2a + ribavirin in normal ALT
arm group label: 2
arm group type: Active Comparator
description: peginterferon alfa-2a + ribavirin in elevated ALT
intervention type: Drug
intervention name: Peginterferon alfa-2a + ribavirin in normal ALT
description: peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
arm group label: 1
other name: Pegasys + ribavirin
intervention type: Drug
intervention name: Peginterferon alfa-2a + ribavirin in elevated ALT
description: peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
arm group label: 2
other name: Pegasys + ribavirin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Miguel Santin, Dr
role: Study Chair
affiliation: Hospital Universitari of Bellvitge
facility: 
facility: 
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country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Universitari de Bellvitge
investigator full name: Miguel Santin
investigator title: Dr
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Ribavirin
mesh term: Peginterferon alfa-2a
mesh term: Interferon-alpha