<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/NCT02219672</url>
  </required_header>
  <id_info>
    <org_study_id>CACT140816</org_study_id>
    <nct_id>NCT02219672</nct_id>
  </id_info>
  <brief_title>Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir In Acute HIV-1 Infection</brief_title>
  <official_title>Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology of the People´s Republic of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection&#xD;
      phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese&#xD;
      patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii&#xD;
      on HIV-1 reservoir.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two arms will be enrolled in this study, 18 naive-treatment Chinese patients in acute HIV-1&#xD;
      infection phase would be allocated to two arms, and treated with the antiretroviral drugs&#xD;
      (Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir). Six months later, 12&#xD;
      patients will be treated with Triplitode, in order to observe the impact of of Triptolide&#xD;
      wilfordii on HIV-1 reservoir of patients in acute infection phase. All patients should be&#xD;
      explored for 18 months in terms of the clinical features, drugs side-effects, and&#xD;
      immunological and viral response, and the HIV-1 reservoir. We hypothesis that Triptolide&#xD;
      wilfordii might further reduce the HIV-1 reservoir. The result would provide proofs for&#xD;
      further practical antiviral therapy for patients in acute infection phase in China or other&#xD;
      resource limited countries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of the immunologic response, virologic response, and hiv-1 reservoir</measure>
    <time_frame>baseline and at Week 4, Week 12, Week 24, Week 36 follow-up visits</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events of the therapy</measure>
    <time_frame>thirty-six months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>AIDS/HIV PROBLEM</condition>
  <arm_group>
    <arm_group_label>Triptolide group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triplitode</intervention_name>
    <description>Drug: Triptolide Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular.&#xD;
Other Name: Tripterygium Wilfordii Hook F (TwHF) Drug: cART Participants who will be enrolled in this Triplitode group would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir .</description>
    <arm_group_label>Triptolide group</arm_group_label>
    <other_name>Triptolide Wilfordii</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir</intervention_name>
    <description>Participants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir.</description>
    <arm_group_label>Comparator group</arm_group_label>
    <other_name>TDF+3TC+LPV/r+RAL for 18 months</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • age between 18-65 years&#xD;
&#xD;
               -  HIV seropositive and confirmed by western blot, confirmed as acute HIV-1&#xD;
                  infection&#xD;
&#xD;
               -  good adherence and follow up in the same place&#xD;
&#xD;
               -  Inform Consent signed&#xD;
&#xD;
               -  ART-naïve&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related&#xD;
             carcinoma;&#xD;
&#xD;
               -  hemoglobin (HGB) &lt; 9 g/dl 、 white blood cell (WBC) &lt; 2000/ul 、 granulin (GRN) &lt;&#xD;
                  1000 /ul 、 platelet (PLT) &lt; 75000 /ul 、 Cr &gt;1.5x ULN 、 ALT or AST or alkaline&#xD;
                  phosphatase (ALP) &gt;3x upper limit of normal (ULN) 、 total bilirubin (TBIL) &gt;2x&#xD;
                  ULN 、 creatine kinase (CK) &gt; 2x ULN;&#xD;
&#xD;
               -  Pregnant or breastfeeding woman or woman with pregnancy plan;&#xD;
&#xD;
               -  Active drug-user;Severe neurological defects;&#xD;
&#xD;
               -  Active alcohol abuse;&#xD;
&#xD;
               -  Severe gastrointestinal ulcer .&#xD;
&#xD;
               -  End-stage disease such as cirrhosis, chronic obstructive pulmonary disease,&#xD;
                  congestive heart failure, recent myocardial ischemia,tumor, etc&#xD;
&#xD;
               -  Those who are undertaking steroids, immunomodulator, anti-inflammatory agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taisheng Li, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wei Lv, MD</last_name>
    <phone>8610-69155046</phone>
    <email>lvweipumch@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fuping Guo, MD</last_name>
    <phone>8610-69155046</phone>
    <email>pumchguofp@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fuping Guo, MD</last_name>
      <phone>86-10-69155082</phone>
      <email>pumchguofp@163.com</email>
    </contact>
    <investigator>
      <last_name>Taisheng Li, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College</investigator_affiliation>
    <investigator_full_name>LI Taisheng</investigator_full_name>
    <investigator_title>department of the infectious disease</investigator_title>
  </responsible_party>
  <keyword>Triptolide wilfordii HIV-1 reservoir acute hiv infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Lopinavir</mesh_term>
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Lamivudine</mesh_term>
    <mesh_term>Raltegravir Potassium</mesh_term>
    <mesh_term>Triptolide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02219672
org study id: CACT140816
nct id: NCT02219672
lead sponsor: 
collaborator: 
has dmc: Yes
This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection
      phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese
      patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii
      on HIV-1 reservoir.
Two arms will be enrolled in this study, 18 naive-treatment Chinese patients in acute HIV-1
      infection phase would be allocated to two arms, and treated with the antiretroviral drugs
      (Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir). Six months later, 12
      patients will be treated with Triplitode, in order to observe the impact of of Triptolide
      wilfordii on HIV-1 reservoir of patients in acute infection phase. All patients should be
      explored for 18 months in terms of the clinical features, drugs side-effects, and
      immunological and viral response, and the HIV-1 reservoir. We hypothesis that Triptolide
      wilfordii might further reduce the HIV-1 reservoir. The result would provide proofs for
      further practical antiviral therapy for patients in acute infection phase in China or other
      resource limited countries.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes of the immunologic response, virologic response, and hiv-1 reservoir
time frame: baseline and at Week 4, Week 12, Week 24, Week 36 follow-up visits
measure: Adverse events of the therapy
time frame: thirty-six months
arm group label: Triptolide group
arm group type: Experimental
description: cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months
arm group label: Comparator group
arm group type: Active Comparator
description: combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months
intervention type: Drug
intervention name: Triplitode
description: Drug: Triptolide Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular.
Other Name: Tripterygium Wilfordii Hook F (TwHF) Drug: cART Participants who will be enrolled in this Triplitode group would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir .
arm group label: Triptolide group
other name: Triptolide Wilfordii
intervention type: Drug
intervention name: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir
description: Participants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir.
arm group label: Comparator group
other name: TDF+3TC+LPV/r+RAL for 18 months
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Taisheng Li, PhD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Wei Lv, MD
phone: 8610-69155046
email: lvweipumch@163.com
last name: Fuping Guo, MD
phone: 8610-69155046
email: pumchguofp@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College
investigator full name: LI Taisheng
investigator title: department of the infectious disease
mesh term: Infections
mesh term: Ritonavir
mesh term: Lopinavir
mesh term: Tenofovir
mesh term: Lamivudine
mesh term: Raltegravir Potassium
mesh term: Triptolide