<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/NCT03785106</url>
  </required_header>
  <id_info>
    <org_study_id>HIV-NAT 255</org_study_id>
    <nct_id>NCT03785106</nct_id>
  </id_info>
  <brief_title>Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals</brief_title>
  <official_title>Implementation for Tuberculosis Preventive Therapy Among Latent Tuberculosis Infection in HIV-infected Individuals Using Novel Regimen of Isoniazid/Rifapentine Daily (4 Weeks) Compared to Isoniazid/Rifapentine Weekly (12 Weeks)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The HIV Netherlands Australia Thailand Research Collaboration</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King Chulalongkorn Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Police General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pranangklao Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taksin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bhumibol Adulyadej Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Klang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chiang Rai Prachanukroh Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sanpatong Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen Sawang Vadhana Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Buddhachinnaraj Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maharat Nakhon Ratchasima Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hatyai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Srinagarind Hospital, Khon Kaen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sisaket Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Public Health Centre 28 Krung thon buri</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The HIV Netherlands Australia Thailand Research Collaboration</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators want to know if ultra-short, effective treatment for latent tuberculosis&#xD;
      (TB) infection (LTBI) could dramatically reduce the global incidence of active TB or not. The&#xD;
      investigators hypothesize that short-course (4-week) daily isoniazid/rifapentine (INH/RPT)&#xD;
      (1HP) is not inferior to standard -course (12 weeks) INH/RPT weekly regimen (3HP) for the&#xD;
      prevention of TB in human immunodeficiency virus (HIV)-infected individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multicenter, randomized, open-label, phase III clinical trial comparing a&#xD;
      4-week daily INH/RPT regimen (1HP) to a 12-weekly INH/RPT (3HP) for the treatment of LTBI in&#xD;
      HIV-infected participants without evidence of active TB. The primary objective will be&#xD;
      efficacy of active TB prevention. The study will also assess safety and tolerability of the&#xD;
      regimens, adherence to the treatments, and patterns of antibiotic resistance among&#xD;
      Mycobacterium tuberculosis (MTB) isolates in participants who fail on these prophylactic&#xD;
      regimens.&#xD;
&#xD;
      Under this study, there is one substudy entitled, &quot;Pharmacokinetic study of rifapentine,&#xD;
      dolutegravir, and tenofovir alafenamide in HIV-infected individual with latent tubersulosis&#xD;
      infection&quot;. There will be a subgroup of patients who will participate in this pharmacokinetic&#xD;
      study of rifapentine and dolutegravir (DTG) / tenofovir alafenamide (TAF). Randomization is&#xD;
      based on cluster of differentiation 4 (CD4) categories : &lt; 200, 200-350, &gt; 500 cells/mm3 and&#xD;
      VL &lt;50 or &gt;50 copies/ml.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 15, 2019</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</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>Parallel Assignment</intervention_model>
    <intervention_model_description>This study is a multicenter, randomized, open-label, phase III clinical trial comparing a 4-week daily INH/RPT regimen (1HP) to a 12-weekly INH/RPT (3HP) for the treatment of LTBI in HIV-infected participants without evidence of active TB.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>efficacy in preventing active TB (proportion of participants that do not have active TB by the end of the study)</measure>
    <time_frame>3 years</time_frame>
    <description>proportion of participants that do not have active TB by the end of the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>safety of the regimens (proportion of participants that do not have any side effects throughout the study period)</measure>
    <time_frame>3 years</time_frame>
    <description>proportion of participants that do not have any side effects throughout the study period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tolerability to the regimens (proportion of participants that can complete the treatment course)</measure>
    <time_frame>3 years</time_frame>
    <description>proportion of participants that can complete the treatment course</description>
  </primary_outcome>
  <primary_outcome>
    <measure>prevalence of drug resistance of MTB</measure>
    <time_frame>3 years</time_frame>
    <description>proportion of participants with drug resistance to MTB</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>severity of the condition</measure>
    <time_frame>3 years</time_frame>
    <description>proportion of participants that have side effects of grade more than or equal to 3 signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>presence of symptoms</measure>
    <time_frame>3 years</time_frame>
    <description>proportion of participants that have symptoms during the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of CBC</measure>
    <time_frame>3 years</time_frame>
    <description>assess the level of CBC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of ALT</measure>
    <time_frame>3 years</time_frame>
    <description>assess the level of ALT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of AST</measure>
    <time_frame>3 years</time_frame>
    <description>assess the level of AST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of total bilirubin</measure>
    <time_frame>3 years</time_frame>
    <description>assess the level of total bilirubin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of ALK</measure>
    <time_frame>3 years</time_frame>
    <description>assess the level of ALK</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of creatinine</measure>
    <time_frame>3 years</time_frame>
    <description>assess the level of creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>death</measure>
    <time_frame>3 years</time_frame>
    <description>time from randomization to death from any cause (TB and non TB events)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>when TB culture becomes positive</measure>
    <time_frame>3 years</time_frame>
    <description>how much time does it take to have positive TB culture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>when TB is confirmed by clinical examination</measure>
    <time_frame>3 years</time_frame>
    <description>how much time does it take to have TB diagnosed via clinical examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adherence to LTBI treatment</measure>
    <time_frame>3 years</time_frame>
    <description>proportion of pills missed during treatment period based on self report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>consistency of taking LTBI treatment</measure>
    <time_frame>3 years</time_frame>
    <description>proportion of pills missed during treatment period based on clinical assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment discontinuation</measure>
    <time_frame>3 years</time_frame>
    <description>proportion of participants with permanent LTBI treatment discontinuation due to all causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>discontinuation of study due to adverse drug reactions</measure>
    <time_frame>3 years</time_frame>
    <description>Proportion of participants that have discontinued the study because of adverse drug reactions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4 count</measure>
    <time_frame>3 years</time_frame>
    <description>CD4 count at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4 count to confirmed or probable TB</measure>
    <time_frame>3 years</time_frame>
    <description>CD4 count at time from randomization to culture-confirmed or probable TB</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time it takes for TB to be confirmed by IGRA</measure>
    <time_frame>3 years</time_frame>
    <description>how much time does it take to confirm TB diagnosis via IGRA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TST result at baseline</measure>
    <time_frame>day 0</time_frame>
    <description>TST result at day 0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>HIV-infected Participants With Latent TB Infection in High TB Burden Country</condition>
  <arm_group>
    <arm_group_label>1HP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4-week daily regimen of weight-based RPT and INH, plus pyridoxine (vitamin B6)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3HP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12-weekly INH/RPT regimen, plus pyridoxine (vitamin B6)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isoniazid/Rifapentine daily (4 weeks) plus pyridoxine (vitamin B6)</intervention_name>
    <description>Isoniazid/Rifapentine daily (4 weeks) plus pyridoxine (vitamin B6)</description>
    <arm_group_label>1HP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isoniazid/Rifapentine 12-weekly plus pyridoxine (vitamin B6)</intervention_name>
    <description>Isoniazid/Rifapentine 12-weekly plus pyridoxine (vitamin B6)</description>
    <arm_group_label>3HP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Documented HIV-1 infection by standard HIV test or plasma HIV-1 RNA viral load and&#xD;
             received ART within 12 months. Participants received ART more than 12 months would be&#xD;
             allowed if CD4 cell counts is less than 350 cells/mm3&#xD;
&#xD;
          2. 18 years and older&#xD;
&#xD;
          3. Evidence of latent TB infection, either by TST ≥5 mm or positive interferon gamma&#xD;
             release assay (IGRA) or history of close contact with active pulmonary TB* within 3&#xD;
             months prior entry visit or residing in a high TB burden area** NOTE * close contact&#xD;
             is referred to person living/sharing in the same room with active pulmonary TB&#xD;
             participants for &gt; 4 hours/day&#xD;
&#xD;
             ** high TB burden areas are defined as areas with an estimated or reported TB&#xD;
             prevalence of 100 to 300/100,000, according to the WHO. Thailand is included in high&#xD;
             TB burden areas.&#xD;
&#xD;
          4. Laboratory values obtained within 30 days prior to entry&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) &gt;750 cells/mm3&#xD;
&#xD;
               -  Hemoglobin &gt;7.4 g/dL&#xD;
&#xD;
               -  Platelet count &gt;50,000/mm3&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])&#xD;
                  and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT])&#xD;
                  &lt;3x upper limit of normal (ULN)&#xD;
&#xD;
               -  Total bilirubin &lt;2.5 X ULN&#xD;
&#xD;
          5. Chest radiograph or chest computed tomography (CT) scan without evidence of active&#xD;
             tuberculosis, unless one has been performed within 90 days prior to entry.&#xD;
&#xD;
          6. Female participants who are participating in sexual activity that could lead to&#xD;
             pregnancy must agree to use one reliable non-hormonal form of contraceptive (i.e.,&#xD;
             condoms, IUD, diaphragm) during RPT treatment and contraception should be remain to 6&#xD;
             weeks post RPT NOTE Female participants who are not of reproductive potential or whose&#xD;
             male partner(s) have undergone successful vasectomy with documented azoospermia or&#xD;
             have documented azoospermia are eligible without requiring the use of contraceptives.&#xD;
             Participant-reported history is acceptable documentation of menopause, hysterectomy,&#xD;
             or bilateral oophorectomy or bilateral tubal ligation.&#xD;
&#xD;
          7. All participants must agree not to participate in a conception process (e.g., active&#xD;
             attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization)&#xD;
             while receiving RPT and for 6 weeks after stopping this drug.&#xD;
&#xD;
          8. Body weight &gt; 40 kg&#xD;
&#xD;
          9. Ability and willingness of participant to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treatment for active or latent TB (pulmonary or extrapulmonary) within 2 years prior&#xD;
             to study entry or presence of any confirmed or probable active TB at screening.&#xD;
&#xD;
          2. History of Isoniazid (INH) or Rifampicin (RIF)/Rifabutin (RFB) resistant TB at any&#xD;
             time prior to study entry or known exposure to INH or RIF/RFB resistant TB (e.g.,&#xD;
             household member of a person with MDR or XDR TB) at any time prior to study entry.&#xD;
&#xD;
          3. Treatment for &gt;14 consecutive days with a rifamycin or &gt;30 consecutive days with INH&#xD;
             at any time during the 2 years prior to enrollment.&#xD;
&#xD;
          4. Current or planned use of protease inhibitor-based ART.&#xD;
&#xD;
          5. Currently on a salvage ART regimen, defined as a regimen started due to confirmed HIV&#xD;
             virologic failure on a prior ART regimen or due to known HIV drug resistance.&#xD;
&#xD;
          6. History of liver cirrhosis at any time prior to study entry.&#xD;
&#xD;
          7. Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and/or&#xD;
             light stools within 90 days prior to entry.&#xD;
&#xD;
          8. Diagnosis of porphyria at any time prior to study entry.&#xD;
&#xD;
          9. Peripheral neuropathy ≥Grade 2 according to the Division of AIDS (DAIDS) Toxicity&#xD;
             Table, within 90 days prior to study entry.&#xD;
&#xD;
         10. Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or&#xD;
             their formulation.&#xD;
&#xD;
         11. Active drug or alcohol use or dependence that, in the opinion of the site&#xD;
             investigator, would interfere with adherence to study requirements.&#xD;
&#xD;
         12. Acute or serious illness requiring systemic treatment and/or hospitalization within 30&#xD;
             days prior to entry.&#xD;
&#xD;
         13. Pregnancy or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anchalee Avihingsanon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HIV-NAT, Thai Red Cross - AIDS Research Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anchalee Avihingsanon, MD, PhD</last_name>
    <phone>026523040</phone>
    <email>anchaleea2009@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>June Ohata, BS</last_name>
    <phone>026523040</phone>
    <email>juneohata4@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Klang Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10100</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Praniti Danpornprasert, MD</last_name>
      <phone>66897702021</phone>
      <email>praniti_d@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Praniti Danpornprasert, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bhumibol Adulyadej Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10220</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Chris Fujitnirun, MD</last_name>
      <phone>66834477602</phone>
      <email>chris_nirun@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Chris Fujitnirun, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>HIV-NAT, Thai Red Cross AIDS Research Centre</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anchalee Avihingsanon, MD, PhD</last_name>
      <phone>662 6523040</phone>
      <email>anchaleea2009@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>June Ohata, BS</last_name>
      <phone>026523040</phone>
      <phone_ext>147</phone_ext>
      <email>juneohata4@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anchalee Avihingsanon, MD, PhD</last_name>
      <phone>66868128889</phone>
      <email>anchaleea2009@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Anchalee Avihingsanon, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Police General Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jirayu Visuthranukul, MD</last_name>
      <phone>6622076000</phone>
      <email>nutjv@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Jirayu Visuthranukul, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Taksin Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10600</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Supunnee Jirajariyavej, MD</last_name>
      <phone>66813744264</phone>
      <email>jsupunee@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Supunnee Jirajariyavej, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>the Public Health Centre 28 Krung thon buri</name>
      <address>
        <city>Bangkok</city>
        <zip>10600</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Thitisant Palakawong, MD</last_name>
      <phone>6628608210</phone>
      <email>thitisant@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Thitisant Palakawong, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanpatong Hospital</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50120</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Virat Klinbuayaem, MD</last_name>
      <phone>6653311404</phone>
      <email>kggvirat@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Virat Klinbuayaem, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chiangrai Prachanukroh Hospital</name>
      <address>
        <city>Chiang Rai</city>
        <zip>57000</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Worarat Imsanguan, MD</last_name>
      <phone>66815568918</phone>
      <email>minkworat@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Worarat Imsanguan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen Savang Vadhana Memorial Hospital</name>
      <address>
        <city>Chon Buri</city>
        <zip>20110</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Palakorn Panarat, MD</last_name>
      <phone>66824401199</phone>
      <email>panarat_3rd@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Palakorn Panarat, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Srinagarind Hospital</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>MD</last_name>
      <phone>66815925907</phone>
      <email>ploencha@kku.ac.th</email>
    </contact>
    <investigator>
      <last_name>Ploenchan Chetchotisakd, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Maharat Nakhon Ratchasima Hospital</name>
      <address>
        <city>Nakhon Ratchasima</city>
        <zip>30000</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sirichai Wiwatrojanagul, MD</last_name>
      <phone>66825321321</phone>
      <email>md.sirichai@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Sirichai Wiwatrojanagul, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pranangklao Hospital</name>
      <address>
        <city>Nonthaburi</city>
        <zip>11000</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sripetcharat Mekviwattanawong, MD</last_name>
      <phone>66818705700</phone>
      <email>sripetcharat@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Sripetcharat Mekviwattanawong, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Buddhachinnaraj Hospital</name>
      <address>
        <city>Phitsanulok</city>
        <zip>65000</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Porntip Treebupachatsakul, MD</last_name>
      <phone>66915349221</phone>
      <email>pornpitt@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Porntip Treebupachatsakul, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sisaket Hospital</name>
      <address>
        <city>Sisaket</city>
        <zip>33000</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Natcha Saetiew, MD</last_name>
      <phone>66815937739</phone>
      <email>snatcha39@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Natcha Saetiew, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hatyai Hospital</name>
      <address>
        <city>Songkhla</city>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Preudtipong Noopetch, MD</last_name>
      <phone>66815925907</phone>
      <email>jasommhai@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Preudtipong Noopetch, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>March 22, 2022</last_update_submitted>
  <last_update_submitted_qc>March 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>people living with HIV (PLHIV)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Latent Tuberculosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Pyridoxine</mesh_term>
    <mesh_term>Pyridoxal</mesh_term>
    <mesh_term>Vitamin B 6</mesh_term>
    <mesh_term>Vitamin B Complex</mesh_term>
    <mesh_term>Isoniazid</mesh_term>
    <mesh_term>Rifapentine</mesh_term>
    <mesh_term>Rifampin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03785106
org study id: HIV-NAT 255
nct id: NCT03785106
lead sponsor: 
collaborator: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators want to know if ultra-short, effective treatment for latent tuberculosis
      (TB) infection (LTBI) could dramatically reduce the global incidence of active TB or not. The
      investigators hypothesize that short-course (4-week) daily isoniazid/rifapentine (INH/RPT)
      (1HP) is not inferior to standard -course (12 weeks) INH/RPT weekly regimen (3HP) for the
      prevention of TB in human immunodeficiency virus (HIV)-infected individuals.
This study is a multicenter, randomized, open-label, phase III clinical trial comparing a
      4-week daily INH/RPT regimen (1HP) to a 12-weekly INH/RPT (3HP) for the treatment of LTBI in
      HIV-infected participants without evidence of active TB. The primary objective will be
      efficacy of active TB prevention. The study will also assess safety and tolerability of the
      regimens, adherence to the treatments, and patterns of antibiotic resistance among
      Mycobacterium tuberculosis (MTB) isolates in participants who fail on these prophylactic
      regimens.

      Under this study, there is one substudy entitled, "Pharmacokinetic study of rifapentine,
      dolutegravir, and tenofovir alafenamide in HIV-infected individual with latent tubersulosis
      infection". There will be a subgroup of patients who will participate in this pharmacokinetic
      study of rifapentine and dolutegravir (DTG) / tenofovir alafenamide (TAF). Randomization is
      based on cluster of differentiation 4 (CD4) categories : < 200, 200-350, > 500 cells/mm3 and
      VL <50 or >50 copies/ml.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a multicenter, randomized, open-label, phase III clinical trial comparing a 4-week daily INH/RPT regimen (1HP) to a 12-weekly INH/RPT (3HP) for the treatment of LTBI in HIV-infected participants without evidence of active TB.
primary purpose: Prevention
masking: None (Open Label)
measure: efficacy in preventing active TB (proportion of participants that do not have active TB by the end of the study)
time frame: 3 years
description: proportion of participants that do not have active TB by the end of the study
measure: safety of the regimens (proportion of participants that do not have any side effects throughout the study period)
time frame: 3 years
description: proportion of participants that do not have any side effects throughout the study period
measure: tolerability to the regimens (proportion of participants that can complete the treatment course)
time frame: 3 years
description: proportion of participants that can complete the treatment course
measure: prevalence of drug resistance of MTB
time frame: 3 years
description: proportion of participants with drug resistance to MTB
measure: severity of the condition
time frame: 3 years
description: proportion of participants that have side effects of grade more than or equal to 3 signs
measure: presence of symptoms
time frame: 3 years
description: proportion of participants that have symptoms during the study period
measure: level of CBC
time frame: 3 years
description: assess the level of CBC
measure: level of ALT
time frame: 3 years
description: assess the level of ALT
measure: level of AST
time frame: 3 years
description: assess the level of AST
measure: level of total bilirubin
time frame: 3 years
description: assess the level of total bilirubin
measure: level of ALK
time frame: 3 years
description: assess the level of ALK
measure: level of creatinine
time frame: 3 years
description: assess the level of creatinine
measure: death
time frame: 3 years
description: time from randomization to death from any cause (TB and non TB events)
measure: when TB culture becomes positive
time frame: 3 years
description: how much time does it take to have positive TB culture
measure: when TB is confirmed by clinical examination
time frame: 3 years
description: how much time does it take to have TB diagnosed via clinical examination
measure: adherence to LTBI treatment
time frame: 3 years
description: proportion of pills missed during treatment period based on self report
measure: consistency of taking LTBI treatment
time frame: 3 years
description: proportion of pills missed during treatment period based on clinical assessment
measure: treatment discontinuation
time frame: 3 years
description: proportion of participants with permanent LTBI treatment discontinuation due to all causes
measure: discontinuation of study due to adverse drug reactions
time frame: 3 years
description: Proportion of participants that have discontinued the study because of adverse drug reactions
measure: CD4 count
time frame: 3 years
description: CD4 count at baseline
measure: CD4 count to confirmed or probable TB
time frame: 3 years
description: CD4 count at time from randomization to culture-confirmed or probable TB
measure: time it takes for TB to be confirmed by IGRA
time frame: 3 years
description: how much time does it take to confirm TB diagnosis via IGRA
measure: TST result at baseline
time frame: day 0
description: TST result at day 0
arm group label: 1HP
arm group type: Experimental
description: 4-week daily regimen of weight-based RPT and INH, plus pyridoxine (vitamin B6)
arm group label: 3HP
arm group type: Active Comparator
description: 12-weekly INH/RPT regimen, plus pyridoxine (vitamin B6)
intervention type: Drug
intervention name: Isoniazid/Rifapentine daily (4 weeks) plus pyridoxine (vitamin B6)
description: Isoniazid/Rifapentine daily (4 weeks) plus pyridoxine (vitamin B6)
arm group label: 1HP
intervention type: Drug
intervention name: Isoniazid/Rifapentine 12-weekly plus pyridoxine (vitamin B6)
description: Isoniazid/Rifapentine 12-weekly plus pyridoxine (vitamin B6)
arm group label: 3HP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anchalee Avihingsanon, MD, PhD
role: Principal Investigator
affiliation: HIV-NAT, Thai Red Cross - AIDS Research Centre
last name: Anchalee Avihingsanon, MD, PhD
phone: 026523040
email: anchaleea2009@gmail.com
last name: June Ohata, BS
phone: 026523040
email: juneohata4@gmail.com
facility: 
status: Not yet recruiting
contact: 
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status: Not yet recruiting
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facility: 
status: Recruiting
contact: 
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facility: 
status: Not yet recruiting
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status: Not yet recruiting
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facility: 
status: Not yet recruiting
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facility: 
status: Not yet recruiting
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facility: 
status: Not yet recruiting
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facility: 
status: Not yet recruiting
contact: 
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facility: 
status: Not yet recruiting
contact: 
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facility: 
status: Not yet recruiting
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facility: 
status: Not yet recruiting
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facility: 
status: Not yet recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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country: Thailand
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Tuberculosis
mesh term: Latent Tuberculosis
mesh term: Vitamins
mesh term: Pyridoxine
mesh term: Pyridoxal
mesh term: Vitamin B 6
mesh term: Vitamin B Complex
mesh term: Isoniazid
mesh term: Rifapentine
mesh term: Rifampin
sharing ipd: No