<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/NCT01712256</url>
  </required_header>
  <id_info>
    <org_study_id>CT-BI Vacc-4x 2012/1</org_study_id>
    <nct_id>NCT01712256</nct_id>
  </id_info>
  <brief_title>Re-boosting of HIV-1 Infected Subjects With Vacc-4x</brief_title>
  <acronym>Re-boost</acronym>
  <official_title>Re-boosting of Subjects Previously Included in the CT BI-Vacc-4x 2007/1 Study. An Open, Multicenter, Immunogenicity, Follow-up Re-boosting Study With Vacc-4x in Subjects Infected With HIV-1 Who Have Maintained an Adequate Response to ART</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bionor Immuno AS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bionor Immuno AS</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced&#xD;
      immunological response and eventually immune deficiency. Vacc-4x is a peptide-based HIV&#xD;
      immunotherapy vaccine and is anticipated to strengthen the immune system's response to HIV.&#xD;
&#xD;
      All patients participating in this trial have previously received the vacc-4x vaccine in&#xD;
      order to reduce the amount of HIV-1 virus in the blood and increase the immune response. The&#xD;
      primary objective of this study is to evaluate if a re-boost with Vacc-4x could further&#xD;
      reduce the amount of HIV-1 virus and increase the immune response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human immunodeficiency virus (HIV) infects the cluster of differentiation 4 (CD4) subset of&#xD;
      T-cells that are critical for initiating immune responses to infection. The level of CD4&#xD;
      cells in the blood is a marker of a patient's immunological status. During the course of an&#xD;
      HIV infection, the number of CD4 cells decreases, resulting in reduced immunological&#xD;
      responsiveness and ultimately immune deficiency.&#xD;
&#xD;
      Current management of an HIV infection includes antiretroviral therapy (ART). The advent of&#xD;
      effective ART in 1996 led to a profound decrease in type 1 HIV (HIV-1)-associated morbidity&#xD;
      and mortality in developed countries where ART has been available.&#xD;
&#xD;
      Despite the ability of ART to inhibit HIV-1 replication, it cannot cure infection, making ART&#xD;
      a lifelong treatment that requires sustained compliance and imposes significant individual&#xD;
      and societal financial burdens on healthcare services. Furthermore, ART side effects (e.g.,&#xD;
      metabolic toxicity and stigmatizing body fat redistribution) often require medication that&#xD;
      further increases the inconveniences and financial burdens of HIV management. Of additional&#xD;
      concern is the emergence of viruses resistant to ART that can result in treatment failure.&#xD;
&#xD;
      Vacc-4x is a peptide-based HIV therapeutic vaccine. The primary objective of Vacc-4x&#xD;
      therapeutic vaccine is to strengthen the immune system's response to HIV p24. ART&#xD;
      dramatically reduces the level of virus in circulation in the body, thereby allowing the&#xD;
      immune system to focus on the therapeutic vaccine that is administered. ART also allows for&#xD;
      the generation of new naïve CD4 cells that can be triggered by the therapeutic vaccine to&#xD;
      generate new immune responses to HIV-1. Subjects are therefore immunized with Vacc-4x in the&#xD;
      presence of ART to generate new HIV-specific immune responses that can sustain immunological&#xD;
      fitness for prolonged periods when patients are removed from ART. It is likely that periodic&#xD;
      boosting on ART will be required to sustain the immunotherapeutic effect - in this way ART&#xD;
      may become an intermittent therapy.&#xD;
&#xD;
      This study is a follow-up, re-boosting study of Study CT-BI Vacc-4x 2007/1 (EudraCT Number&#xD;
      2007-006302-13) performed in US and Europe (UK, Germany, Spain and Italy). All subjects to be&#xD;
      included have been given a therapeutic immunization with Vacc-4x during the CT-BI Vacc-4x&#xD;
      2007/1 study. During the study a reduction in the viral load set-point (mean viral load at&#xD;
      Week 48 and Week 52, or if Week 52 not reached, mean viral load of the last two measured&#xD;
      values before restart of ART) was seen in the Vacc-4x group compared to placebo group.&#xD;
      Further stimulation of the immune system by re-boosting with Vacc-4x could reduce the viral&#xD;
      load set-point further.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 2</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>Vacc-4x Effect on Viral Load Set-point</measure>
    <time_frame>37 weeks</time_frame>
    <description>Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vacc-4x Effect on Immune Response Measured as CD4 Count</measure>
    <time_frame>36 weeks</time_frame>
    <description>Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vacc-4x Effect on Immune Response Measured as CD8 Count</measure>
    <time_frame>36 weeks</time_frame>
    <description>Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration</measure>
    <time_frame>4 weeks</time_frame>
    <description>The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>37 weeks</time_frame>
    <description>To evaluate the safety and tolerability of re-boosting with Vacc-4x by number of participants with Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>HIV-1 Infection</condition>
  <arm_group>
    <arm_group_label>Re-boosting with Vacc-4x</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vacc-4x</intervention_name>
    <description>Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.</description>
    <arm_group_label>Re-boosting with Vacc-4x</arm_group_label>
    <other_name>Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Completed immunization regimen with Vacc-4x active and stopped ART (at Week 28) in the&#xD;
             CT-BI Vacc-4x 2007/1 study. (No re-start of ART is required).&#xD;
&#xD;
          2. Documented pre-study CD4 cell count ≥400x106/L.&#xD;
&#xD;
          3. Documented pre-study viral load &lt; 300 000copies/mL.&#xD;
&#xD;
          4. Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Reported AIDS-defining illness within the previous year.&#xD;
&#xD;
          2. Malignant disease.&#xD;
&#xD;
          3. On chronic treatment with immune-suppressive therapy.&#xD;
&#xD;
          4. Unacceptable values of the hematologic and clinical chemistry parameters, as judged by&#xD;
             the Investigator, including creatinine values &gt;1.5 x upper limit of normal (ULN), and&#xD;
             AST, ALT and alkaline phosphatase (ALP) values &gt;2.5 x ULN.&#xD;
&#xD;
          5. Concurrent chronic active infection such as viral hepatitis B or C or tuberculosis.&#xD;
&#xD;
          6. Pregnant or breastfeeding women.&#xD;
&#xD;
          7. Women of childbearing potential not using reliable and adequate contraceptive methods&#xD;
             (defined as: use of oral, implanted, injectable, mechanical or barrier products for&#xD;
             the prevention of pregnancy; practicing abstinence; sterile) during the 5 weeks&#xD;
             re-boosting period including the DTH and for 2 weeks after the DTH test, or sexually&#xD;
             active male subjects with partners of child bearing potential unwilling to practice&#xD;
             effective contraception during the 5 weeks re-boosting period including the DTH and&#xD;
             for 12 weeks after the DTH-test.&#xD;
&#xD;
          8. Current participation in other clinical therapeutic studies.&#xD;
&#xD;
          9. Incapability of compliance to treatment protocol, in the opinion of the Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>63 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vidar Wendel-Hansen, Dr. med</last_name>
    <role>Study Director</role>
    <affiliation>Bionor Pharma ASA, Kronprinsesse Märthas Plass 1, P.O. Box 1477 Vika, NO-0116 Oslo, Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA CARE Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EIPMED - Gesellschaft fűr epidemiologische und klinische Forschung in der Medizin mbH Rubensstrasse 125</name>
      <address>
        <city>Berlin</city>
        <zip>12157</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I; Immunologische Ambulanz, Siegmund-Freud-Str. 25</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>20127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat.</name>
      <address>
        <city>Barcelona</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrison Wing St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kran AM, Sommerfelt MA, Baksaas I, Sorensen B, Kvale D. Delayed-type hypersensitivity responses to HIV Gag p24 relate to clinical outcome after peptide-based therapeutic immunization for chronic HIV infection. APMIS. 2012 Mar;120(3):204-9. doi: 10.1111/j.1600-0463.2011.02843.x. Epub 2011 Nov 27.</citation>
    <PMID>22339677</PMID>
  </reference>
  <reference>
    <citation>Lind A, Sommerfelt M, Holmberg JO, Baksaas I, Sorensen B, Kvale D. Intradermal vaccination of HIV-infected patients with short HIV Gag p24-like peptides induces CD4 + and CD8 + T cell responses lasting more than seven years. Scand J Infect Dis. 2012 Aug;44(8):566-72. doi: 10.3109/00365548.2011.653581. Epub 2012 Feb 19.</citation>
    <PMID>22339485</PMID>
  </reference>
  <reference>
    <citation>Jones T. Vacc-4x, a therapeutic vaccine comprised of four engineered peptides for the potential treatment of HIV infection. Curr Opin Investig Drugs. 2010 Aug;11(8):964-70.</citation>
    <PMID>20721838</PMID>
  </reference>
  <reference>
    <citation>Kran AM, Sorensen B, Sommerfelt MA, Nyhus J, Baksaas I, Kvale D. Long-term HIV-specific responses and delayed resumption of antiretroviral therapy after peptide immunization targeting dendritic cells. AIDS. 2006 Feb 28;20(4):627-30. doi: 10.1097/01.aids.0000210620.75707.ac.</citation>
    <PMID>16470131</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>January 11, 2017</results_first_submitted>
  <results_first_submitted_qc>January 11, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 6, 2017</results_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CD4</keyword>
  <keyword>Clinical trial</keyword>
  <keyword>Human immunodeficiency virus-1 (HIV-1)</keyword>
  <keyword>HIV</keyword>
  <keyword>Immunomodulary</keyword>
  <keyword>Infection</keyword>
  <keyword>Phase II</keyword>
  <keyword>Re-boost</keyword>
  <keyword>Vaccine</keyword>
  <keyword>Vacc-4x</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Re-boosting With Vacc-4x</title>
          <description>Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.&#xD;
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Re-boosting With Vacc-4x</title>
          <description>Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.&#xD;
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.0" spread="7.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.64" spread="5.077"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time since HIV diagnosis</title>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5786.8" spread="2043.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total time on ART</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="138.6" spread="57.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Currently on ART</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-ART HIV-1 viral load</title>
          <population>Examination of the data suggest that the CRF question was interpreted in different ways with respect to stopping and starting ART, and changing the composition of the ART received and the answers given cannot be relied upon.</population>
          <units>copies/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67502.4" spread="150008.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Vacc-4x Effect on Viral Load Set-point</title>
        <description>Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.</description>
        <time_frame>37 weeks</time_frame>
        <population>In the ITT population there were 20 evaluable subjects out of 30 (3 subjects did not receive ART from Screening through Week 12) and in the PP population there were 18 evaluable subjects out of 27 (an additional 3 subjects did not discontinue ART at Week 12).</population>
        <group_list>
          <group group_id="O1">
            <title>Re-boosting With Vacc-4x</title>
            <description>Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.&#xD;
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.</description>
          </group>
        </group_list>
        <measure>
          <title>Vacc-4x Effect on Viral Load Set-point</title>
          <description>Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.</description>
          <population>In the ITT population there were 20 evaluable subjects out of 30 (3 subjects did not receive ART from Screening through Week 12) and in the PP population there were 18 evaluable subjects out of 27 (an additional 3 subjects did not discontinue ART at Week 12).</population>
          <units>Copies/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CT Vacc-4x 2012/1 VL set point, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38455.0" spread="46628.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT Vacc-4x 2012/1 VL set point, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40088.8" spread="48923.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT-BI Vacc-4x 2007/1 VL Set Point, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45253.9" spread="55676.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT-BI Vacc-4x 2007/1 VL Set Point, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47336.8" spread="58031.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vacc-4x Effect on Immune Response Measured as CD4 Count</title>
        <description>Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1</description>
        <time_frame>36 weeks</time_frame>
        <population>The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).&#xD;
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Re-boosting With Vacc-4x</title>
            <description>Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.&#xD;
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.</description>
          </group>
        </group_list>
        <measure>
          <title>Vacc-4x Effect on Immune Response Measured as CD4 Count</title>
          <description>Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1</description>
          <population>The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).&#xD;
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.</population>
          <units>cells/micro liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline; ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="782.21" spread="278.303"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="795.74" spread="283.990"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="764.8" spread="245.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="778.1" spread="731.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="791.1" spread="321.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="805.6" spread="328.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="772.2" spread="324.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="789.4" spread="326.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="705.2" spread="233.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="718.1" spread="235.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="574.9" spread="185.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="581.2" spread="191.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="544.0" spread="144.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="557.9" spread="142.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="534.2" spread="140.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="542.5" spread="145.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="579.0" spread="59.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="579.0" spread="59.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vacc-4x Effect on Immune Response Measured as CD8 Count</title>
        <description>Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1</description>
        <time_frame>36 weeks</time_frame>
        <population>The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).&#xD;
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Re-boosting With Vacc-4x</title>
            <description>Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.&#xD;
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.</description>
          </group>
        </group_list>
        <measure>
          <title>Vacc-4x Effect on Immune Response Measured as CD8 Count</title>
          <description>Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1</description>
          <population>The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).&#xD;
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.</population>
          <units>cells/micro liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline; ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="979.43" spread="352.891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="972.19" spread="364.810"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="988.7" spread="315.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="971.4" spread="320.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="926.3" spread="361.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="919.0" spread="369.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="952.0" spread="451.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="954.0" spread="455.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="962.6" spread="307.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="966.9" spread="311.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1282.1" spread="633.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1257.8" spread="649.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1430.9" spread="588.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1444.6" spread="609.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1261.9" spread="511.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1245.1" spread="536.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1230.7" spread="192.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1302.7" spread="192.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration</title>
        <description>The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.</description>
        <time_frame>4 weeks</time_frame>
        <population>The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).&#xD;
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Re-boosting With Vacc-4x</title>
            <description>Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.&#xD;
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.</description>
          </group>
        </group_list>
        <measure>
          <title>Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration</title>
          <description>The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.</description>
          <population>The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).&#xD;
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema</title>
        <description>The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.</description>
        <time_frame>4 Weeks</time_frame>
        <population>The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).&#xD;
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Re-boosting With Vacc-4x</title>
            <description>Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.&#xD;
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.</description>
          </group>
        </group_list>
        <measure>
          <title>Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema</title>
          <description>The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.</description>
          <population>The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).&#xD;
Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, ITT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, PP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</title>
        <description>To evaluate the safety and tolerability of re-boosting with Vacc-4x by number of participants with Adverse Events</description>
        <time_frame>37 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Re-boosting With Vacc-4x</title>
            <description>Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.&#xD;
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</title>
          <description>To evaluate the safety and tolerability of re-boosting with Vacc-4x by number of participants with Adverse Events</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>With any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With injection site reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With any TESAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With any AE leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Re-boosting With Vacc-4x</title>
          <description>Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.&#xD;
Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>HIV infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal cancer stage unspecified</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Aphthous stomatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" events="21" subjects_affected="16" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Influenza-like illness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Application site reaction</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Injection site Vesicles</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremities</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </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>The Sponsor (or designee) will prepare a final report on the study. The Investigator may not publish or present any information on this study without the express written approval of the Sponsor. Additionally, the Sponsor, may, for any reason, withhold approval for publication or presentation.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Maja Sommerfelt</name_or_title>
      <organization>Bionor Pharma ASA</organization>
      <phone>+4723010960</phone>
      <email>ms@bionorpharma.com</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/NCT01712256
org study id: CT-BI Vacc-4x 2012/1
nct id: NCT01712256
lead sponsor: 
has dmc: Yes
During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced
      immunological response and eventually immune deficiency. Vacc-4x is a peptide-based HIV
      immunotherapy vaccine and is anticipated to strengthen the immune system's response to HIV.

      All patients participating in this trial have previously received the vacc-4x vaccine in
      order to reduce the amount of HIV-1 virus in the blood and increase the immune response. The
      primary objective of this study is to evaluate if a re-boost with Vacc-4x could further
      reduce the amount of HIV-1 virus and increase the immune response.
Human immunodeficiency virus (HIV) infects the cluster of differentiation 4 (CD4) subset of
      T-cells that are critical for initiating immune responses to infection. The level of CD4
      cells in the blood is a marker of a patient's immunological status. During the course of an
      HIV infection, the number of CD4 cells decreases, resulting in reduced immunological
      responsiveness and ultimately immune deficiency.

      Current management of an HIV infection includes antiretroviral therapy (ART). The advent of
      effective ART in 1996 led to a profound decrease in type 1 HIV (HIV-1)-associated morbidity
      and mortality in developed countries where ART has been available.

      Despite the ability of ART to inhibit HIV-1 replication, it cannot cure infection, making ART
      a lifelong treatment that requires sustained compliance and imposes significant individual
      and societal financial burdens on healthcare services. Furthermore, ART side effects (e.g.,
      metabolic toxicity and stigmatizing body fat redistribution) often require medication that
      further increases the inconveniences and financial burdens of HIV management. Of additional
      concern is the emergence of viruses resistant to ART that can result in treatment failure.

      Vacc-4x is a peptide-based HIV therapeutic vaccine. The primary objective of Vacc-4x
      therapeutic vaccine is to strengthen the immune system's response to HIV p24. ART
      dramatically reduces the level of virus in circulation in the body, thereby allowing the
      immune system to focus on the therapeutic vaccine that is administered. ART also allows for
      the generation of new naïve CD4 cells that can be triggered by the therapeutic vaccine to
      generate new immune responses to HIV-1. Subjects are therefore immunized with Vacc-4x in the
      presence of ART to generate new HIV-specific immune responses that can sustain immunological
      fitness for prolonged periods when patients are removed from ART. It is likely that periodic
      boosting on ART will be required to sustain the immunotherapeutic effect - in this way ART
      may become an intermittent therapy.

      This study is a follow-up, re-boosting study of Study CT-BI Vacc-4x 2007/1 (EudraCT Number
      2007-006302-13) performed in US and Europe (UK, Germany, Spain and Italy). All subjects to be
      included have been given a therapeutic immunization with Vacc-4x during the CT-BI Vacc-4x
      2007/1 study. During the study a reduction in the viral load set-point (mean viral load at
      Week 48 and Week 52, or if Week 52 not reached, mean viral load of the last two measured
      values before restart of ART) was seen in the Vacc-4x group compared to placebo group.
      Further stimulation of the immune system by re-boosting with Vacc-4x could reduce the viral
      load set-point further.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Vacc-4x Effect on Viral Load Set-point
time frame: 37 weeks
description: Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.
measure: Vacc-4x Effect on Immune Response Measured as CD4 Count
time frame: 36 weeks
description: Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1
measure: Vacc-4x Effect on Immune Response Measured as CD8 Count
time frame: 36 weeks
description: Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1
measure: Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration
time frame: 4 weeks
description: The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.
measure: Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema
time frame: 4 Weeks
description: The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
time frame: 37 weeks
description: To evaluate the safety and tolerability of re-boosting with Vacc-4x by number of participants with Adverse Events
arm group label: Re-boosting with Vacc-4x
arm group type: Experimental
description: Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.
intervention type: Biological
intervention name: Vacc-4x
description: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
arm group label: Re-boosting with Vacc-4x
other name: Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13
criteria: 
gender: All
minimum age: 18 Years
maximum age: 63 Years
healthy volunteers: No
last name: Vidar Wendel-Hansen, Dr. med
role: Study Director
affiliation: Bionor Pharma ASA, Kronprinsesse Märthas Plass 1, P.O. Box 1477 Vika, NO-0116 Oslo, Norway
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country: Germany
country: Italy
country: Spain
country: United Kingdom
country: United States
citation: Kran AM, Sommerfelt MA, Baksaas I, Sorensen B, Kvale D. Delayed-type hypersensitivity responses to HIV Gag p24 relate to clinical outcome after peptide-based therapeutic immunization for chronic HIV infection. APMIS. 2012 Mar;120(3):204-9. doi: 10.1111/j.1600-0463.2011.02843.x. Epub 2011 Nov 27.
PMID: 22339677
citation: Lind A, Sommerfelt M, Holmberg JO, Baksaas I, Sorensen B, Kvale D. Intradermal vaccination of HIV-infected patients with short HIV Gag p24-like peptides induces CD4 + and CD8 + T cell responses lasting more than seven years. Scand J Infect Dis. 2012 Aug;44(8):566-72. doi: 10.3109/00365548.2011.653581. Epub 2012 Feb 19.
PMID: 22339485
citation: Jones T. Vacc-4x, a therapeutic vaccine comprised of four engineered peptides for the potential treatment of HIV infection. Curr Opin Investig Drugs. 2010 Aug;11(8):964-70.
PMID: 20721838
citation: Kran AM, Sorensen B, Sommerfelt MA, Nyhus J, Baksaas I, Kvale D. Long-term HIV-specific responses and delayed resumption of antiretroviral therapy after peptide immunization targeting dendritic cells. AIDS. 2006 Feb 28;20(4):627-30. doi: 10.1097/01.aids.0000210620.75707.ac.
PMID: 16470131
responsible party type: Sponsor
mesh term: Infections
sharing ipd: No
ipd description: Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 