<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/NCT01666990</url>
  </required_header>
  <id_info>
    <org_study_id>Beijing302-007</org_study_id>
    <nct_id>NCT01666990</nct_id>
  </id_info>
  <brief_title>Tripterygium Wilfordii Hook F (TwHF) Treatment for Immune Non-responders With HIV-1 Infection</brief_title>
  <official_title>Phase 1/2 Study of Tripterygium Wilfordii Hook F (TwHF) Treatment for Evaluation the Efficacy and Safety in Immune Non-responders With HIV-1 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing 302 Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing 302 Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      HIV-1 infection is characterized by progressive depletion of CD4+ T cells that eventually&#xD;
      leads to clinically significant immunodeficiency. A chronic generalized immune activation is&#xD;
      now being recognized to be the main driving force for T cell depletion, loss of anti-HIV-1&#xD;
      immunity and disease progression during chronic HIV-1 infection. However, it is still unknown&#xD;
      whether reducing immune activation will restore CD4 T cell counts and leading to immune&#xD;
      reconstitution in chronic HIV infection. Tripterygium Wilfordii Hook F (TwHF) has been&#xD;
      demonstrated to decrease immune activation of the host, and can suppress inflammation in&#xD;
      human diseases. Here, the investigators propose a hypothesis that TwHF can reduce immune&#xD;
      over-activation which subsequently leads to the restoration of CD4 T-cell counts and immune&#xD;
      reconstitution in HIV-infected immune non-responders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although HIV-1 infection is characterized by progressive depletion of CD4+ T cells that&#xD;
      eventually leads to clinically significant immunodeficiency, a chronic generalized immune&#xD;
      activation is now being recognized to be the main driving force for T cell depletion, loss of&#xD;
      anti-HIV-1 immunity and disease progression during chronic HIV-1 infection. In particular,&#xD;
      this immune activation has been identified as a disease determinant independent of viral load&#xD;
      or cell death in HIV-1 infection. A series of clinical evidences have indicated that&#xD;
      activated CD8 T cells may attack body cells infected with viruses. Because of this, CD4 cells&#xD;
      infected with HIV are frequently destroyed by CD8 cells.&#xD;
&#xD;
      In traditional Chinese medicine, extracts of the roots of the medicinal vine Tripterygium&#xD;
      wilfordii Hook F (TwHF) (known in China as &quot;lei gong teng&quot; or &quot;thunder god vine&quot;) have shown&#xD;
      therapeutic promise in treating autoimmune and inflammatory conditions as well as cancer. In&#xD;
      this extracts, three diterpenoids-triptolide, tripdiolide, and triptonide-are the most&#xD;
      abundant and account for the immunosuppressive and anti-inflammatory effects observed in both&#xD;
      in vitro and in vivo studies. Recently, different extracts of TwHF have been used in Chinese&#xD;
      allopathic medicine for the treatment of autoimmune and inflammatory diseases, and small&#xD;
      controlled trials reported good responses with TwHF extracts in patients with cadaveric&#xD;
      kidney transplants and Crohn disease. In particular, a multicenter, double-blind, active&#xD;
      comparator trial of a standardized TwHF extract in patients with active rheumatoid arthritis&#xD;
      has shown a 20% improvement in American College of Rheumatology criteria in patients with&#xD;
      TwHF than with sulfasalazine. Thus, TwHF may reduce inflammatory responses and promote tissue&#xD;
      recovery in human diseases.&#xD;
&#xD;
      The purpose of this study is to learn whether and how well TwHF reduces the level of&#xD;
      activation of CD8 cells in people infected with HIV. The decreased activation of CD8 cells&#xD;
      may lead to a more CD4 T cell restoration and immune reconstitution in HIV infection. This&#xD;
      study will also look at how well TwHF is tolerated and its safety in HIV- infected patients.&#xD;
&#xD;
      Participants in this study will be randomly assigned to one of two treatment arms:&#xD;
&#xD;
      Arm A: Participants will receive 48 weeks of TwHF treatment. Arm B: Participants will receive&#xD;
      48 weeks of placebo Study treatment will be given 20 mg, three times per day for a full 48&#xD;
      weeks. After treatment has started, participants will be asked to come to the clinic on Weeks&#xD;
      4, 8, 12, 16, 24, 36, and 48. At each visit participants will receive enough study treatment&#xD;
      to last until the next visit. Each visit will last between 2 and 3 hours. At most visits&#xD;
      participants will have a physical exam, answer questions about any medications they are&#xD;
      taking and how they are feeling, and have blood drawn for safety to assess CD4/CD8 cell&#xD;
      counts and viral load. Some additional blood will also be stored for immunology testing. At&#xD;
      some visits participants will be asked questions about their medication and medical history,&#xD;
      have pupils dilated, have a hearing test, and have an electrocardiogram (EKG). Some visits&#xD;
      will require participants to arrive fasting. Pregnancy tests may also be conducted if the&#xD;
      participant is able to become pregnant or if pregnancy is suspected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the total CD4 T cell counts compared with CD4 T cell counts at baseline</measure>
    <time_frame>At Baseline and at week 4, 8, 12, 24, 36 and 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the CD38 expression on CD8 T cells</measure>
    <time_frame>At Baseline and at week 4, 8, 12, 24, 36 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>at baseline and up to week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma RNA copies/mL</measure>
    <time_frame>At Entry and at week 12 , 24 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the ratio of CD4 and CD8 T cells</measure>
    <time_frame>At baseline and at week 4, 8, 12, 24, 36 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the total cell counts of peripheral CD3 T cells</measure>
    <time_frame>At baseline and at week 4, 8, 12, 24, 36 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the total cell counts of peripheral CD45RA+CCR7+ naive T cells</measure>
    <time_frame>At baseline and at week 4, 8, 12, 24, 36 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the cytokine levels of IL-1b in the plasma</measure>
    <time_frame>At entry and at week 12, 24 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the IL-2-producing T-cell number under stimulation with HIV Gag peptide pool</measure>
    <time_frame>At entry and at week 12, 24 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the HLA-DR expression on CD8 T cells</measure>
    <time_frame>At Baseline and at week 4, 8, 12, 24, 36 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the total cell number of peripheral CD8 T cells</measure>
    <time_frame>At baseline and at week 4, 8, 12, 24, 36 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the total cell counts of peripheral CD45RA+CCR7- central memory T cells</measure>
    <time_frame>At baseline and at week 4, 8, 12, 24, 36 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the total cell counts of peripheral CD45RA-CCR7- effector memory T cells</measure>
    <time_frame>At baseline and at week 4, 8, 12, 24, 36 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the cytokine levels of IL-6 in the plasma</measure>
    <time_frame>At entry and at week 12, 24 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the cytokine levels of TNF-a in the plasma</measure>
    <time_frame>At entry and at week 12, 24 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the levels of total IgG in the plasma</measure>
    <time_frame>At entry and at week 12, 24 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the cytokine levels of IFNa in the plasma</measure>
    <time_frame>At entry and at week 12, 24 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the IFN-g-producing T-cell number under stimulation with HIV Gag peptide pool</measure>
    <time_frame>At entry and at week 12, 24 and 48</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>TwHF, lifestyle counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive TwHF (20mg each time, 3 times per day, for 48 weeks) from Day 0 through the Week 48 study visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo, Lifestyle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo treatment (20mg each time, three times per day for 48 weeks) from Day 0 through the Week 48 study visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TwHF</intervention_name>
    <description>Taken oral, three times per day, at a dose of 20 mg/time for 48 weeks.</description>
    <arm_group_label>TwHF, lifestyle counseling</arm_group_label>
    <other_name>treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo treatment</intervention_name>
    <description>Taken oral, three times per day, at a dose of 20 mg/time for 48 weeks.</description>
    <arm_group_label>placebo, Lifestyle</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. HIV infected&#xD;
&#xD;
          2. antiretroviral therapy (ART) for at least 24 months prior to study entry and continue&#xD;
             within the 12 months after study entry&#xD;
&#xD;
          3. CD4 count less than or equal to 250 cells/mm3 continuously before entry and at&#xD;
             screening, obtained within 30 days prior to study entry&#xD;
&#xD;
          4. Viral load less than or equal to 400 copies/mL obtained within 30 days prior to study&#xD;
             entry&#xD;
&#xD;
          5. Certain specified laboratory values obtained within 30 days prior to study entry. More&#xD;
             information on this criterion can be found in the study protocol.&#xD;
&#xD;
          6. Documentation that pre-entry specimen for the primary immune activation endpoint&#xD;
             responses has been obtained&#xD;
&#xD;
          7. No history of CDC category C AIDS-related opportunistic infections&#xD;
&#xD;
          8. Karnofsky performance score greater than or equal to 70 within 30 days prior to study&#xD;
             entry&#xD;
&#xD;
          9. Ability and willingness to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serious illness requiring systemic treatment and/or hospitalization within 30 days&#xD;
             prior to study entry&#xD;
&#xD;
          2. Renal insufficiency, defined as serum creatinine greater than 1.5 mg/L, within 30 days&#xD;
             prior to study entry&#xD;
&#xD;
          3. History of retinal disease&#xD;
&#xD;
          4. History of neoplasm other than localized squamous cell carcinoma of the skin&#xD;
&#xD;
          5. History of cardiac conduction abnormality or cardiomyopathy. More information on this&#xD;
             criterion can be found in the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fu-Sheng Wang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing 302 Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zheng Zhang, Doctor</last_name>
    <phone>86-10-63879735</phone>
    <email>zhangzheng1975@yahoo.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing 302 Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100039</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zheng Zhang, Doctor</last_name>
      <phone>86-10-63879735</phone>
      <email>zhangzheng1975@yahoo.com.cn</email>
    </contact>
    <investigator>
      <last_name>Fu-Sheng Wang, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>the Yunnan Hospital of Infectious Diseases</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650301</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xicheng Wang, Doctor</last_name>
      <phone>86-0871-6256092</phone>
      <email>wxch62597@21cn.com</email>
    </contact>
    <investigator>
      <last_name>Xicheng Wang, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Hammer SM, Squires KE, Hughes MD, Grimes JM, Demeter LM, Currier JS, Eron JJ Jr, Feinberg JE, Balfour HH Jr, Deyton LR, Chodakewitz JA, Fischl MA. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team. N Engl J Med. 1997 Sep 11;337(11):725-33. doi: 10.1056/NEJM199709113371101.</citation>
    <PMID>9287227</PMID>
  </reference>
  <reference>
    <citation>Mocroft A, Vella S, Benfield TL, Chiesi A, Miller V, Gargalianos P, d'Arminio Monforte A, Yust I, Bruun JN, Phillips AN, Lundgren JD. Changing patterns of mortality across Europe in patients infected with HIV-1. EuroSIDA Study Group. Lancet. 1998 Nov 28;352(9142):1725-30. doi: 10.1016/s0140-6736(98)03201-2.</citation>
    <PMID>9848347</PMID>
  </reference>
  <reference>
    <citation>Appay V, Sauce D. Immune activation and inflammation in HIV-1 infection: causes and consequences. J Pathol. 2008 Jan;214(2):231-41. doi: 10.1002/path.2276.</citation>
    <PMID>18161758</PMID>
  </reference>
  <reference>
    <citation>Li T, Wu N, Dai Y, Qiu Z, Han Y, Xie J, Zhu T, Li Y. Reduced thymic output is a major mechanism of immune reconstitution failure in HIV-infected patients after long-term antiretroviral therapy. Clin Infect Dis. 2011 Nov;53(9):944-51. doi: 10.1093/cid/cir552. Epub 2011 Sep 29.</citation>
    <PMID>21960716</PMID>
  </reference>
  <reference>
    <citation>Goldbach-Mansky R, Wilson M, Fleischmann R, Olsen N, Silverfield J, Kempf P, Kivitz A, Sherrer Y, Pucino F, Csako G, Costello R, Pham TH, Snyder C, van der Heijde D, Tao X, Wesley R, Lipsky PE. Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial. Ann Intern Med. 2009 Aug 18;151(4):229-40, W49-51. doi: 10.7326/0003-4819-151-4-200908180-00005.</citation>
    <PMID>19687490</PMID>
  </reference>
  <reference>
    <citation>Kupchan SM, Court WA, Dailey RG Jr, Gilmore CJ, Bryan RF. Triptolide and tripdiolide, novel antileukemic diterpenoid triepoxides from Tripterygium wilfordii. J Am Chem Soc. 1972 Oct 4;94(20):7194-5. doi: 10.1021/ja00775a078. No abstract available.</citation>
    <PMID>5072337</PMID>
  </reference>
  <reference>
    <citation>Ji SM, Wang QW, Chen JS, Sha GZ, Liu ZH, Li LS. Clinical trial of Tripterygium Wilfordii Hook F. in human kidney transplantation in China. Transplant Proc. 2006 Jun;38(5):1274-9. doi: 10.1016/j.transproceed.2006.03.017.</citation>
    <PMID>16797280</PMID>
  </reference>
  <reference>
    <citation>Tao X, Lipsky PE. The Chinese anti-inflammatory and immunosuppressive herbal remedy Tripterygium wilfordii Hook F. Rheum Dis Clin North Am. 2000 Feb;26(1):29-50, viii. doi: 10.1016/s0889-857x(05)70118-6.</citation>
    <PMID>10680192</PMID>
  </reference>
  <reference>
    <citation>Qiu D, Zhao G, Aoki Y, Shi L, Uyei A, Nazarian S, Ng JC, Kao PN. Immunosuppressant PG490 (triptolide) inhibits T-cell interleukin-2 expression at the level of purine-box/nuclear factor of activated T-cells and NF-kappaB transcriptional activation. J Biol Chem. 1999 May 7;274(19):13443-50. doi: 10.1074/jbc.274.19.13443.</citation>
    <PMID>10224109</PMID>
  </reference>
  <reference>
    <citation>Tao X, Schulze-Koops H, Ma L, Cai J, Mao Y, Lipsky PE. Effects of Tripterygium wilfordii hook F extracts on induction of cyclooxygenase 2 activity and prostaglandin E2 production. Arthritis Rheum. 1998 Jan;41(1):130-8. doi: 10.1002/1529-0131(199801)41:13.0.CO;2-4.</citation>
    <PMID>9433878</PMID>
  </reference>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>August 14, 2015</last_update_submitted>
  <last_update_submitted_qc>August 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tripterygium wilfordii Hook F (TwHF)</keyword>
  <keyword>HIV</keyword>
  <keyword>CD4</keyword>
  <keyword>immune over-activation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_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/NCT01666990
org study id: Beijing302-007
nct id: NCT01666990
lead sponsor: 
has dmc: Yes
HIV-1 infection is characterized by progressive depletion of CD4+ T cells that eventually
      leads to clinically significant immunodeficiency. A chronic generalized immune activation is
      now being recognized to be the main driving force for T cell depletion, loss of anti-HIV-1
      immunity and disease progression during chronic HIV-1 infection. However, it is still unknown
      whether reducing immune activation will restore CD4 T cell counts and leading to immune
      reconstitution in chronic HIV infection. Tripterygium Wilfordii Hook F (TwHF) has been
      demonstrated to decrease immune activation of the host, and can suppress inflammation in
      human diseases. Here, the investigators propose a hypothesis that TwHF can reduce immune
      over-activation which subsequently leads to the restoration of CD4 T-cell counts and immune
      reconstitution in HIV-infected immune non-responders.
Although HIV-1 infection is characterized by progressive depletion of CD4+ T cells that
      eventually leads to clinically significant immunodeficiency, a chronic generalized immune
      activation is now being recognized to be the main driving force for T cell depletion, loss of
      anti-HIV-1 immunity and disease progression during chronic HIV-1 infection. In particular,
      this immune activation has been identified as a disease determinant independent of viral load
      or cell death in HIV-1 infection. A series of clinical evidences have indicated that
      activated CD8 T cells may attack body cells infected with viruses. Because of this, CD4 cells
      infected with HIV are frequently destroyed by CD8 cells.

      In traditional Chinese medicine, extracts of the roots of the medicinal vine Tripterygium
      wilfordii Hook F (TwHF) (known in China as "lei gong teng" or "thunder god vine") have shown
      therapeutic promise in treating autoimmune and inflammatory conditions as well as cancer. In
      this extracts, three diterpenoids-triptolide, tripdiolide, and triptonide-are the most
      abundant and account for the immunosuppressive and anti-inflammatory effects observed in both
      in vitro and in vivo studies. Recently, different extracts of TwHF have been used in Chinese
      allopathic medicine for the treatment of autoimmune and inflammatory diseases, and small
      controlled trials reported good responses with TwHF extracts in patients with cadaveric
      kidney transplants and Crohn disease. In particular, a multicenter, double-blind, active
      comparator trial of a standardized TwHF extract in patients with active rheumatoid arthritis
      has shown a 20% improvement in American College of Rheumatology criteria in patients with
      TwHF than with sulfasalazine. Thus, TwHF may reduce inflammatory responses and promote tissue
      recovery in human diseases.

      The purpose of this study is to learn whether and how well TwHF reduces the level of
      activation of CD8 cells in people infected with HIV. The decreased activation of CD8 cells
      may lead to a more CD4 T cell restoration and immune reconstitution in HIV infection. This
      study will also look at how well TwHF is tolerated and its safety in HIV- infected patients.

      Participants in this study will be randomly assigned to one of two treatment arms:

      Arm A: Participants will receive 48 weeks of TwHF treatment. Arm B: Participants will receive
      48 weeks of placebo Study treatment will be given 20 mg, three times per day for a full 48
      weeks. After treatment has started, participants will be asked to come to the clinic on Weeks
      4, 8, 12, 16, 24, 36, and 48. At each visit participants will receive enough study treatment
      to last until the next visit. Each visit will last between 2 and 3 hours. At most visits
      participants will have a physical exam, answer questions about any medications they are
      taking and how they are feeling, and have blood drawn for safety to assess CD4/CD8 cell
      counts and viral load. Some additional blood will also be stored for immunology testing. At
      some visits participants will be asked questions about their medication and medical history,
      have pupils dilated, have a hearing test, and have an electrocardiogram (EKG). Some visits
      will require participants to arrive fasting. Pregnancy tests may also be conducted if the
      participant is able to become pregnant or if pregnancy is suspected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: the total CD4 T cell counts compared with CD4 T cell counts at baseline
time frame: At Baseline and at week 4, 8, 12, 24, 36 and 48
measure: the CD38 expression on CD8 T cells
time frame: At Baseline and at week 4, 8, 12, 24, 36 and 48
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: at baseline and up to week 48
measure: plasma RNA copies/mL
time frame: At Entry and at week 12 , 24 and 48
measure: the ratio of CD4 and CD8 T cells
time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
measure: the total cell counts of peripheral CD3 T cells
time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
measure: the total cell counts of peripheral CD45RA+CCR7+ naive T cells
time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
measure: the cytokine levels of IL-1b in the plasma
time frame: At entry and at week 12, 24 and 48
measure: the IL-2-producing T-cell number under stimulation with HIV Gag peptide pool
time frame: At entry and at week 12, 24 and 48
measure: the HLA-DR expression on CD8 T cells
time frame: At Baseline and at week 4, 8, 12, 24, 36 and 48
measure: the total cell number of peripheral CD8 T cells
time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
measure: the total cell counts of peripheral CD45RA+CCR7- central memory T cells
time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
measure: the total cell counts of peripheral CD45RA-CCR7- effector memory T cells
time frame: At baseline and at week 4, 8, 12, 24, 36 and 48
measure: the cytokine levels of IL-6 in the plasma
time frame: At entry and at week 12, 24 and 48
measure: the cytokine levels of TNF-a in the plasma
time frame: At entry and at week 12, 24 and 48
measure: the levels of total IgG in the plasma
time frame: At entry and at week 12, 24 and 48
measure: the cytokine levels of IFNa in the plasma
time frame: At entry and at week 12, 24 and 48
measure: the IFN-g-producing T-cell number under stimulation with HIV Gag peptide pool
time frame: At entry and at week 12, 24 and 48
arm group label: TwHF, lifestyle counseling
arm group type: Experimental
description: Participants will receive TwHF (20mg each time, 3 times per day, for 48 weeks) from Day 0 through the Week 48 study visit.
arm group label: placebo, Lifestyle
arm group type: Placebo Comparator
description: Participants will receive placebo treatment (20mg each time, three times per day for 48 weeks) from Day 0 through the Week 48 study visit.
intervention type: Drug
intervention name: TwHF
description: Taken oral, three times per day, at a dose of 20 mg/time for 48 weeks.
arm group label: TwHF, lifestyle counseling
other name: treatment
intervention type: Drug
intervention name: placebo treatment
description: Taken oral, three times per day, at a dose of 20 mg/time for 48 weeks.
arm group label: placebo, Lifestyle
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Fu-Sheng Wang, Professor
role: Principal Investigator
affiliation: Beijing 302 Hospital
last name: Zheng Zhang, Doctor
phone: 86-10-63879735
email: zhangzheng1975@yahoo.com.cn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: China
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PMID: 9433878
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections