<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/NCT03302299</url>
  </required_header>
  <id_info>
    <org_study_id>2U01AA020776-06</org_study_id>
    <nct_id>NCT03302299</nct_id>
  </id_info>
  <brief_title>Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT)</brief_title>
  <acronym>ADEPTT</acronym>
  <official_title>URBAN ARCH (3/5) Uganda Cohort TB Preventive Therapy for HIV-infected Alcohol Users in Uganda: an Evaluation of Safety Tolerability and Adherence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mbarara University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) will examine the safety&#xD;
      and tolerability of, and adherence to, 6 months of daily INH (6H) in 300 TB and HIV-infected&#xD;
      persons (200 drinkers and 100 non-drinkers) in Uganda. The first aim is to evaluate the&#xD;
      safety and tolerability of 6H overall and by level of alcohol use. The second aim is to&#xD;
      estimate adherence and compare adherence by level of alcohol use and at 3 and 6 months.&#xD;
      Self-reported measures of alcohol use will be augmented by phosphatidylethanol (PEth), an&#xD;
      established biomarker of alcohol use. Objective measures of adherence will include electronic&#xD;
      pill bottle monitoring and a novel measure of INH exposure, INH concentration in hair. The&#xD;
      study will actively monitor for hepatotoxicity using the U.S. standard of care for TB&#xD;
      preventive therapy for heavy drinkers and discontinue if any Grade 3/4 toxicities are&#xD;
      detected. The investigators will use the safety, tolerability, and adherence results,&#xD;
      together with the known efficacy and mortality benefit of TB preventive therapy in&#xD;
      HIV-infected persons in SSA, and an established decision analytic model of TB preventive&#xD;
      therapy to conduct the third aim: to determine whether the benefits of TB preventive therapy&#xD;
      outweigh the toxicity risks for HIV-infected drinkers in resource limited settings. The study&#xD;
      will additionally follow the cohort every 6 months after completing INH to monitor drinking&#xD;
      and the development of active TB.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tuberculosis (TB) is the leading cause of mortality in persons with HIV worldwide, accounting&#xD;
      for 20-33% of HIV-related deaths, and is a high-priority area of research in HIV/AIDS by the&#xD;
      NIH. TB preventive therapy decreases both all-cause mortality and active TB in persons with&#xD;
      HIV by 30-50% above and beyond the benefits of antiretroviral therapy (ART) alone. Based on&#xD;
      these findings, the World Health Organization (WHO) recommends isoniazid (INH) preventive&#xD;
      therapy (IPT) for all persons with HIV in resource constrained settings. However, the WHO&#xD;
      warns against the use of IPT in persons with &quot;regular and heavy alcohol use.&quot; This exclusion&#xD;
      stems from concern for increased hepatotoxicity in heavy drinkers in settings where liver&#xD;
      enzymes are not routinely monitored. Heavy drinking in persons with HIV is very common,&#xD;
      approximately 25%, in sub-Saharan Africa (SSA). Heavy drinking increases the risk for active&#xD;
      TB at least threefold; thus, HIV-infected alcohol users should be prioritized for TB&#xD;
      prevention. However, no studies have systematically assessed the safety of TB preventive&#xD;
      therapy in heavy drinkers with or without HIV infection. It is critical to examine the safety&#xD;
      and tolerability of TB preventive therapy for HIV-infected drinkers, given the high rates of&#xD;
      HIV, TB infection, and alcohol comorbidities worldwide. While the risk of toxicity exists,&#xD;
      the risk of TB disease could outweigh the toxicity harms. Thus, it is also crucial to&#xD;
      determine whether the mortality benefits outweigh the toxicity risks for this significant&#xD;
      portion of the HIV-infected population.&#xD;
&#xD;
      In addition, TB preventive therapy is only effective if taken consistently for the full&#xD;
      course. Alcohol use is an established risk factor for decreased ART pill taking and active TB&#xD;
      treatment discontinuation. Whether HIV-infected drinkers on ART can be adherent to TB&#xD;
      preventive therapy is not known. Therefore it is essential to determine the level of&#xD;
      adherence to TB preventive therapy by HIV-infected drinkers on ART, thus this study aims to&#xD;
      examine adherence to TB preventative therapy as well.&#xD;
&#xD;
      This is a study to examine 6 months of daily INH (6H) among N=300 persons co-infected with&#xD;
      HIV and TB. The aims of the study are:&#xD;
&#xD;
      Aim 1: To examine the safety and tolerability of 6H in HIV/TB co-infected drinkers, measured&#xD;
      by hepatotoxicity and treatment discontinuation rates. The main aim is to estimate safety and&#xD;
      tolerability overall among drinkers (primary) and by level of drinking (secondary).&#xD;
&#xD;
      Aim 2: To determine the level of TB preventive therapy adherence overall among drinkers and&#xD;
      by level of drinking, and at 3 and 6 months. The main goal of this aim is to estimate&#xD;
      adherence overall among drinkers (primary). Secondarily the investigators will estimate&#xD;
      adherence by level of drinking (heavy, current but not heavy drinkers, and non-drinkers) and&#xD;
      compare adherence across drinking levels. The investigators hypothesize that adherence will&#xD;
      be highest among the non-drinkers.&#xD;
&#xD;
      Aim 3: To determine whether the benefits of providing TB preventive therapy to HIV-infected&#xD;
      drinkers in resource-limited settings outweigh the risks compared to no treatment. The&#xD;
      investigators hypothesize that providing TB preventive therapy will result in longer life&#xD;
      expectancy and quality-adjusted life expectancy than not providing TB preventive therapy&#xD;
      (current standard of care).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 7, 2017</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Grade 3/4 hepatotoxicity</measure>
    <time_frame>Hepatotoxicity occurring during the six month course (180 pills) of INH (which may be taken over a maximum of 9 months)</time_frame>
    <description>Safety will be assessed by the occurrence of a Grade 3/4 hepatotoxicity at any time during the assigned treatment period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment discontinuation</measure>
    <time_frame>Treatment discontinuation occuring during the six month course (180 pills) of INH (which may be taken over a maximum of 9 months)</time_frame>
    <description>Lack of tolerability will be defined as any treatment discontinuation prior to completion of the prescribed course (6 months of INH over a maximum period of 9 months) due to side effects or ALT/AST elevations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>INH medication adherence by Electronic Medication Monitoring</measure>
    <time_frame>Adherence will be measured over the 6 months on INH or until INH discontinuation (whichever is shorter)</time_frame>
    <description>EMM adherence will be defined as the number of pill bottle openings (no more than 1 per day counted) divided by the number of prescribed doses over the study period openings (no more than 1 per day counted) divided by the number of prescribed doses over the study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported INH medication adherence by visual analog scale</measure>
    <time_frame>Self-reported INH medication adherence via VAS will be measured 3- and 6- months after starting INH</time_frame>
    <description>The visual analog scale (VAS) asks the patient to identify their past month percent adherence on a visual scale that ranges from 0 to 100%. The VAS is administered at 3- and 6-month interviews. The average of the two measures for this outcome will be used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported INH medication adherence by the Self Rating Single Item (SRSI) scale</measure>
    <time_frame>Self-reported INH medication adherence via SRSI will be measured 3- and 6- months after starting INH</time_frame>
    <description>The study will administer the Self Rating Single Item (SRSI) adherence scale, which asks participants to rate their ability to take their medications as prescribed over the past month at the 3- and 6-month interview. The lower score of the 2 surveys administered will be used.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>INH concentration in hair</measure>
    <time_frame>Measured at 3- and 6- months after INH initiation</time_frame>
    <description>INH concentration in hair (ng/mg) will be measured at 3- and 6- months during INH therapy. Average concentration will be used.</description>
  </other_outcome>
  <other_outcome>
    <measure>Liver injury</measure>
    <time_frame>Study screening visit</time_frame>
    <description>ALT or AST elevations (&gt;2x the upper limit of normal) at study screening</description>
  </other_outcome>
  <other_outcome>
    <measure>Latent tuberculosis</measure>
    <time_frame>Study screening visit</time_frame>
    <description>Latent tuberculosis assessed at screening via tuberculin skin testing</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">302</enrollment>
  <condition>Tuberculosis</condition>
  <condition>HIV/AIDS</condition>
  <condition>Alcohol Abuse</condition>
  <arm_group>
    <arm_group_label>Isoniazid &amp; pyridoxine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Isoniazid 300 mg oral tablet: 300 mg daily by mouth for 6 months. Pyridoxine 25 mg oral tablet: 25mg daily by mouth for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isoniazid 300 Mg ORAL TABLET</intervention_name>
    <description>The study intervention will include a single arm given (1) 6H: 300 mg INH daily by mouth for 6 months.</description>
    <arm_group_label>Isoniazid &amp; pyridoxine</arm_group_label>
    <other_name>INH</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pyridoxine 25 Mg Oral Tablet</intervention_name>
    <description>All participants will also receive 25 mg pyridoxine (vitamin B-6) daily by mouth for 6 months for the treatment duration to reduce the risk of INH-induced peripheral neuropathy.</description>
    <arm_group_label>Isoniazid &amp; pyridoxine</arm_group_label>
    <other_name>Vitamin B6</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 years old&#xD;
&#xD;
          2. Patient of the MRRH ISS Clinic&#xD;
&#xD;
          3. HIV-infected&#xD;
&#xD;
          4. Consume alcohol (self-reported consumption in the prior 3 months) (2/3) OR prior year&#xD;
             non-drinker (1/3)&#xD;
&#xD;
          5. Live within 2 hours of travel time to the ISS Clinic&#xD;
&#xD;
          6. Fluent in either Runyankole or English&#xD;
&#xD;
          7. No ALT/AST elevations (&lt; = 2X ULN) confirmed by testing&#xD;
&#xD;
          8. On ART for at least 6 months&#xD;
&#xD;
          9. No history of active TB, TB treatment, or TB preventive therapy&#xD;
&#xD;
         10. No probable current active TB as determined by symptom screening and followed by chest&#xD;
             X-ray and Xpert MTB/RIF (if symptomatic)&#xD;
&#xD;
         11. Positive TST results confirmed by testing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Plans to move out of the catchment area within 6 months&#xD;
&#xD;
          2. Probable TB via symptom screen and subsequent assessments&#xD;
&#xD;
          3. History or current or past active TB, TB treatment, or TB preventive therapy&#xD;
&#xD;
          4. ALT or AST &gt;2x ULN&#xD;
&#xD;
          5. Pregnant women&#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>Judith A Hahn, PhD, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mbarara University of Science and Technology/Mbarara Regional Referral Hospital</name>
      <address>
        <city>Mbarara</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <link>
    <url>http://reliefweb.int/report/world/how-aids-changed-everything-mdg6-15-years-15-lessons-hope-aids-response</url>
    <description>How AIDS Changed Everything: 2014 Global Statistics. UNAIDS;2015.</description>
  </link>
  <link>
    <url>http://apps.who.int/iris/bitstream/10665/44472/1/9789241500708_eng.pdf</url>
    <description>Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings.</description>
  </link>
  <link>
    <url>http://www.unaids.org/en/regionscountries/countries/uganda</url>
    <description>UNAIDS Country Report, Uganda. 2014</description>
  </link>
  <link>
    <url>http://www.who.int/substance_abuse/publications/global_alcohol_report/en/</url>
    <description>Global Status Report on Alcohol and Health. Geneva: World Health Organization;2014</description>
  </link>
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  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>June 9, 2021</last_update_submitted>
  <last_update_submitted_qc>June 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adherence</keyword>
  <keyword>Hepatotoxicity</keyword>
  <keyword>Phosphatidtylethanol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pyridoxine</mesh_term>
    <mesh_term>Vitamin B 6</mesh_term>
    <mesh_term>Isoniazid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The investigators will make de-identified data available to investigators with relevant and well-articulated research plans, after the main study analyses have been conducted. No personal identifiers will be shared, and nor identifiers that could be linked back to the original study ID. In addition, some journals require de-identified data to be posted for public access.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03302299/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03302299
org study id: 2U01AA020776-06
nct id: NCT03302299
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) will examine the safety
      and tolerability of, and adherence to, 6 months of daily INH (6H) in 300 TB and HIV-infected
      persons (200 drinkers and 100 non-drinkers) in Uganda. The first aim is to evaluate the
      safety and tolerability of 6H overall and by level of alcohol use. The second aim is to
      estimate adherence and compare adherence by level of alcohol use and at 3 and 6 months.
      Self-reported measures of alcohol use will be augmented by phosphatidylethanol (PEth), an
      established biomarker of alcohol use. Objective measures of adherence will include electronic
      pill bottle monitoring and a novel measure of INH exposure, INH concentration in hair. The
      study will actively monitor for hepatotoxicity using the U.S. standard of care for TB
      preventive therapy for heavy drinkers and discontinue if any Grade 3/4 toxicities are
      detected. The investigators will use the safety, tolerability, and adherence results,
      together with the known efficacy and mortality benefit of TB preventive therapy in
      HIV-infected persons in SSA, and an established decision analytic model of TB preventive
      therapy to conduct the third aim: to determine whether the benefits of TB preventive therapy
      outweigh the toxicity risks for HIV-infected drinkers in resource limited settings. The study
      will additionally follow the cohort every 6 months after completing INH to monitor drinking
      and the development of active TB.
Tuberculosis (TB) is the leading cause of mortality in persons with HIV worldwide, accounting
      for 20-33% of HIV-related deaths, and is a high-priority area of research in HIV/AIDS by the
      NIH. TB preventive therapy decreases both all-cause mortality and active TB in persons with
      HIV by 30-50% above and beyond the benefits of antiretroviral therapy (ART) alone. Based on
      these findings, the World Health Organization (WHO) recommends isoniazid (INH) preventive
      therapy (IPT) for all persons with HIV in resource constrained settings. However, the WHO
      warns against the use of IPT in persons with "regular and heavy alcohol use." This exclusion
      stems from concern for increased hepatotoxicity in heavy drinkers in settings where liver
      enzymes are not routinely monitored. Heavy drinking in persons with HIV is very common,
      approximately 25%, in sub-Saharan Africa (SSA). Heavy drinking increases the risk for active
      TB at least threefold; thus, HIV-infected alcohol users should be prioritized for TB
      prevention. However, no studies have systematically assessed the safety of TB preventive
      therapy in heavy drinkers with or without HIV infection. It is critical to examine the safety
      and tolerability of TB preventive therapy for HIV-infected drinkers, given the high rates of
      HIV, TB infection, and alcohol comorbidities worldwide. While the risk of toxicity exists,
      the risk of TB disease could outweigh the toxicity harms. Thus, it is also crucial to
      determine whether the mortality benefits outweigh the toxicity risks for this significant
      portion of the HIV-infected population.

      In addition, TB preventive therapy is only effective if taken consistently for the full
      course. Alcohol use is an established risk factor for decreased ART pill taking and active TB
      treatment discontinuation. Whether HIV-infected drinkers on ART can be adherent to TB
      preventive therapy is not known. Therefore it is essential to determine the level of
      adherence to TB preventive therapy by HIV-infected drinkers on ART, thus this study aims to
      examine adherence to TB preventative therapy as well.

      This is a study to examine 6 months of daily INH (6H) among N=300 persons co-infected with
      HIV and TB. The aims of the study are:

      Aim 1: To examine the safety and tolerability of 6H in HIV/TB co-infected drinkers, measured
      by hepatotoxicity and treatment discontinuation rates. The main aim is to estimate safety and
      tolerability overall among drinkers (primary) and by level of drinking (secondary).

      Aim 2: To determine the level of TB preventive therapy adherence overall among drinkers and
      by level of drinking, and at 3 and 6 months. The main goal of this aim is to estimate
      adherence overall among drinkers (primary). Secondarily the investigators will estimate
      adherence by level of drinking (heavy, current but not heavy drinkers, and non-drinkers) and
      compare adherence across drinking levels. The investigators hypothesize that adherence will
      be highest among the non-drinkers.

      Aim 3: To determine whether the benefits of providing TB preventive therapy to HIV-infected
      drinkers in resource-limited settings outweigh the risks compared to no treatment. The
      investigators hypothesize that providing TB preventive therapy will result in longer life
      expectancy and quality-adjusted life expectancy than not providing TB preventive therapy
      (current standard of care).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Grade 3/4 hepatotoxicity
time frame: Hepatotoxicity occurring during the six month course (180 pills) of INH (which may be taken over a maximum of 9 months)
description: Safety will be assessed by the occurrence of a Grade 3/4 hepatotoxicity at any time during the assigned treatment period.
measure: Treatment discontinuation
time frame: Treatment discontinuation occuring during the six month course (180 pills) of INH (which may be taken over a maximum of 9 months)
description: Lack of tolerability will be defined as any treatment discontinuation prior to completion of the prescribed course (6 months of INH over a maximum period of 9 months) due to side effects or ALT/AST elevations.
measure: INH medication adherence by Electronic Medication Monitoring
time frame: Adherence will be measured over the 6 months on INH or until INH discontinuation (whichever is shorter)
description: EMM adherence will be defined as the number of pill bottle openings (no more than 1 per day counted) divided by the number of prescribed doses over the study period openings (no more than 1 per day counted) divided by the number of prescribed doses over the study period.
measure: Self-reported INH medication adherence by visual analog scale
time frame: Self-reported INH medication adherence via VAS will be measured 3- and 6- months after starting INH
description: The visual analog scale (VAS) asks the patient to identify their past month percent adherence on a visual scale that ranges from 0 to 100%. The VAS is administered at 3- and 6-month interviews. The average of the two measures for this outcome will be used for analysis.
measure: Self-reported INH medication adherence by the Self Rating Single Item (SRSI) scale
time frame: Self-reported INH medication adherence via SRSI will be measured 3- and 6- months after starting INH
description: The study will administer the Self Rating Single Item (SRSI) adherence scale, which asks participants to rate their ability to take their medications as prescribed over the past month at the 3- and 6-month interview. The lower score of the 2 surveys administered will be used.
measure: INH concentration in hair
time frame: Measured at 3- and 6- months after INH initiation
description: INH concentration in hair (ng/mg) will be measured at 3- and 6- months during INH therapy. Average concentration will be used.
measure: Liver injury
time frame: Study screening visit
description: ALT or AST elevations (>2x the upper limit of normal) at study screening
measure: Latent tuberculosis
time frame: Study screening visit
description: Latent tuberculosis assessed at screening via tuberculin skin testing
arm group label: Isoniazid & pyridoxine
arm group type: Experimental
description: Isoniazid 300 mg oral tablet: 300 mg daily by mouth for 6 months. Pyridoxine 25 mg oral tablet: 25mg daily by mouth for 6 months.
intervention type: Drug
intervention name: Isoniazid 300 Mg ORAL TABLET
description: The study intervention will include a single arm given (1) 6H: 300 mg INH daily by mouth for 6 months.
arm group label: Isoniazid & pyridoxine
other name: INH
intervention type: Drug
intervention name: Pyridoxine 25 Mg Oral Tablet
description: All participants will also receive 25 mg pyridoxine (vitamin B-6) daily by mouth for 6 months for the treatment duration to reduce the risk of INH-induced peripheral neuropathy.
arm group label: Isoniazid & pyridoxine
other name: Vitamin B6
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Judith A Hahn, PhD, MA
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: Uganda
url: http://reliefweb.int/report/world/how-aids-changed-everything-mdg6-15-years-15-lessons-hope-aids-response
description: How AIDS Changed Everything: 2014 Global Statistics. UNAIDS;2015.
url: http://apps.who.int/iris/bitstream/10665/44472/1/9789241500708_eng.pdf
description: Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings.
url: http://www.unaids.org/en/regionscountries/countries/uganda
description: UNAIDS Country Report, Uganda. 2014
url: http://www.who.int/substance_abuse/publications/global_alcohol_report/en/
description: Global Status Report on Alcohol and Health. Geneva: World Health Organization;2014
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responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Alcoholism
mesh term: Pyridoxine
mesh term: Vitamin B 6
mesh term: Isoniazid
sharing ipd: No
ipd description: The investigators will make de-identified data available to investigators with relevant and well-articulated research plans, after the main study analyses have been conducted. No personal identifiers will be shared, and nor identifiers that could be linked back to the original study ID. In addition, some journals require de-identified data to be posted for public access.
provided document: 