<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/NCT02236234</url>
  </required_header>
  <id_info>
    <org_study_id>2010/07076-4</org_study_id>
    <secondary_id>FAPESP</secondary_id>
    <nct_id>NCT02236234</nct_id>
  </id_info>
  <brief_title>Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil</brief_title>
  <acronym>HPV</acronym>
  <official_title>Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Besides the specific response to vaccine antigens, the investigators will analyze the&#xD;
      anti-HPV immune response in HIV-1-infected men in different strata of immune deficiency. The&#xD;
      hypothesis will be tested by stratification by T CD4 + lymphocytes in an attempt to assess&#xD;
      the range of the count with the highest possibility of vaccine response. Thus, knowledge of&#xD;
      vaccine response in HIV-infected patients, indicate which patients would have greater&#xD;
      potential for vaccine response in vivo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be divided into three groups. Patients with HIV-1 infection will be subdivided&#xD;
      into groups according to T CD4 + lymphocytes at the time of vaccination: Over 500 CD4 T cells&#xD;
      count and bellow 500 CD4 T cells count. A healthy control group will be also studied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of Anti-HPV antibody titers</measure>
    <time_frame>0, 30 and 180 days of vaccination anti-HPV</time_frame>
    <description>The anti-HPV titers will be compared from baseline to the date of sample collection</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one group with HPV vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HPV vaccine</intervention_name>
    <description>HPV vaccine</description>
    <arm_group_label>Vaccine</arm_group_label>
    <other_name>cerverix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: HIV&#xD;
&#xD;
          -  Men with age between 35 and 45 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or previous infection with human papillomavirus (HPV)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jorge casseb, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Tropical Medicine of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>April 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Jorge Casseb</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>HPV</keyword>
  <keyword>Clinical trial</keyword>
  <keyword>outcome</keyword>
  <!-- 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/NCT02236234
org study id: 2010/07076-4
secondary id: FAPESP
nct id: NCT02236234
lead sponsor: 
has dmc: No
Besides the specific response to vaccine antigens, the investigators will analyze the
      anti-HPV immune response in HIV-1-infected men in different strata of immune deficiency. The
      hypothesis will be tested by stratification by T CD4 + lymphocytes in an attempt to assess
      the range of the count with the highest possibility of vaccine response. Thus, knowledge of
      vaccine response in HIV-infected patients, indicate which patients would have greater
      potential for vaccine response in vivo.
The study will be divided into three groups. Patients with HIV-1 infection will be subdivided
      into groups according to T CD4 + lymphocytes at the time of vaccination: Over 500 CD4 T cells
      count and bellow 500 CD4 T cells count. A healthy control group will be also studied.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Presence of Anti-HPV antibody titers
time frame: 0, 30 and 180 days of vaccination anti-HPV
description: The anti-HPV titers will be compared from baseline to the date of sample collection
arm group label: Vaccine
arm group type: Experimental
description: one group with HPV vaccine
intervention type: Biological
intervention name: HPV vaccine
description: HPV vaccine
arm group label: Vaccine
other name: cerverix
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: jorge casseb, phD
role: Principal Investigator
affiliation: USP
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Jorge Casseb
investigator title: PI