<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/NCT01694017</url>
  </required_header>
  <id_info>
    <org_study_id>10465</org_study_id>
    <nct_id>NCT01694017</nct_id>
  </id_info>
  <brief_title>Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy</brief_title>
  <official_title>Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Christian Medical College, Vellore, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tufts University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare clinical, economical and quality of life (QOL)&#xD;
      outcomes in patients living with HIV on zidovudine/stavudine regimen and tenofovir regimen.&#xD;
      This study will be an unblinded randomized trial. The first step will be empirical data&#xD;
      collection for one year for calculating the incremental cost effectiveness ratio (ICER). The&#xD;
      second step will be to perform a simulation model for calculating long term ICER.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug regimen for treatment of HIV at the free ART centers in India includes&#xD;
      stavudine/zidovudine and lamivudine with nevirapine. Approximately 20-30% of the patients on&#xD;
      this regimen experience drug toxicity within the first six months of treatment.&#xD;
&#xD;
      The tenofovir based regimen is one of the least toxic regimens with less than 5% of patients&#xD;
      experiencing toxicity. Tenofovir based regimen is not considered as the first choice for ART&#xD;
      in the Indian governmental program, because it is more expensive than the other drug&#xD;
      regimens, in spite of better clinical outcomes in resource limited settings. The cost of&#xD;
      treatment with stavudine/zidovudine is presumed to be less expensive and is the preferred&#xD;
      first line treatment, but we believe that although the direct cost to the government is less,&#xD;
      patients on zidovudine/stavudine regimen have to spend more money for additional hospital&#xD;
      visits and admissions, laboratory investigations and other medications due to ART induced&#xD;
      toxicity.&#xD;
&#xD;
      There are no published data including economic, clinical and quality of life outcomes to&#xD;
      compare the two regimens from India. Hence, this unblinded randomized pragmatic comparative&#xD;
      effectiveness study will seek to identify the best treatment for HIV patients based on the&#xD;
      incremental cost effectiveness ratio (ICER), quality of life (QOL) and clinical outcomes.&#xD;
&#xD;
      The clinical outcomes include viral suppression, change in the CD4 and proportion of patients&#xD;
      with toxicity and opportunistic infections. Direct costs for the treatment will be&#xD;
      calculated. The QOL scores will be estimated and compared between the regimens using&#xD;
      questionnaires. QOL scores and direct cost will be used as utilities for calculating ICER.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Viral suppression</measure>
    <time_frame>End of follow-up : end of 12th Month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CD4 levels</measure>
    <time_frame>End of Months 6 and 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Drug related toxicity</measure>
    <time_frame>Months : 1,2,3,4,5,6,7,8,9,10,11,12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>opportunistic infections</measure>
    <time_frame>Months: 1,2,3,4,5,6,7,8,9,10,11,12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Direct costs</measure>
    <time_frame>Months: 1,2,3,4,5,6,7,8,9,10,11,12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Month 1 and end of months 4,8 and 12</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Zidovudine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tenofovir</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir</intervention_name>
    <description>tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year</description>
    <arm_group_label>Tenofovir</arm_group_label>
    <other_name>Atripla</other_name>
    <other_name>Vonavir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zidovudine</intervention_name>
    <description>zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year</description>
    <arm_group_label>Zidovudine</arm_group_label>
    <other_name>Lazid-N</other_name>
    <other_name>Duovir-N</other_name>
    <other_name>Zidolam-N</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All treatment naïve patients above 18 years confirmed with the diagnosis of HIV&#xD;
&#xD;
          -  Eligible for initiation of cART based on the National Aids Control Organization of&#xD;
             India&#xD;
&#xD;
          -  Consenting for participation and follow-up for one year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients requiring hospitalization at the time of initiation of treatment&#xD;
&#xD;
          -  Patients with opportunistic infections including tuberculosis&#xD;
&#xD;
          -  Patients with co-morbidities like diabetes or neurological impairments&#xD;
&#xD;
          -  Pregnant and breast feeding women and children less than 18 years will be excluded&#xD;
&#xD;
          -  All patients living outside the catchment area of CMC and not willing for regular&#xD;
             follow-up will be excluded&#xD;
&#xD;
          -  Patients with a creatinine clearance less than 50 mL/min will be excluded.&#xD;
&#xD;
          -  Patients receiving other co-medications with possible interaction with tenofovir, like&#xD;
             antifungal (voriconazole), ergot derivatives (dihydroergotamine, ergonovine,&#xD;
             ergotamine, and methylergonovine), benzodiazepines (midazolam, triazolam), calcium&#xD;
             channel blocker (bepridil), GI motility agent (cisapride), neuroleptic (pimozide) and&#xD;
             St.John's wort will be excluded.&#xD;
&#xD;
          -  Patients with hemoglobin less than 8 gm/dl&#xD;
&#xD;
          -  Patients started on tenofovir regimen by the treating physician at the time of&#xD;
             enrollment will be excluded&#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>Christine C Wanke, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Tufts University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sowmyanarayanan V Thuppal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Christian Medical College</name>
      <address>
        <city>Vellore</city>
        <state>Tamilnadu</state>
        <zip>632004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>November 20, 2014</last_update_submitted>
  <last_update_submitted_qc>November 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tufts University</investigator_affiliation>
    <investigator_full_name>Christine A. Wanke</investigator_full_name>
    <investigator_title>Professor of Medicine and Public Health and Community Medicine</investigator_title>
  </responsible_party>
  <keyword>HIV,treatment,cost effectiveness,drug toxicity,QOL,costs</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Zidovudine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01694017
org study id: 10465
nct id: NCT01694017
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare clinical, economical and quality of life (QOL)
      outcomes in patients living with HIV on zidovudine/stavudine regimen and tenofovir regimen.
      This study will be an unblinded randomized trial. The first step will be empirical data
      collection for one year for calculating the incremental cost effectiveness ratio (ICER). The
      second step will be to perform a simulation model for calculating long term ICER.
The drug regimen for treatment of HIV at the free ART centers in India includes
      stavudine/zidovudine and lamivudine with nevirapine. Approximately 20-30% of the patients on
      this regimen experience drug toxicity within the first six months of treatment.

      The tenofovir based regimen is one of the least toxic regimens with less than 5% of patients
      experiencing toxicity. Tenofovir based regimen is not considered as the first choice for ART
      in the Indian governmental program, because it is more expensive than the other drug
      regimens, in spite of better clinical outcomes in resource limited settings. The cost of
      treatment with stavudine/zidovudine is presumed to be less expensive and is the preferred
      first line treatment, but we believe that although the direct cost to the government is less,
      patients on zidovudine/stavudine regimen have to spend more money for additional hospital
      visits and admissions, laboratory investigations and other medications due to ART induced
      toxicity.

      There are no published data including economic, clinical and quality of life outcomes to
      compare the two regimens from India. Hence, this unblinded randomized pragmatic comparative
      effectiveness study will seek to identify the best treatment for HIV patients based on the
      incremental cost effectiveness ratio (ICER), quality of life (QOL) and clinical outcomes.

      The clinical outcomes include viral suppression, change in the CD4 and proportion of patients
      with toxicity and opportunistic infections. Direct costs for the treatment will be
      calculated. The QOL scores will be estimated and compared between the regimens using
      questionnaires. QOL scores and direct cost will be used as utilities for calculating ICER.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Viral suppression
time frame: End of follow-up : end of 12th Month
measure: Change in CD4 levels
time frame: End of Months 6 and 12
measure: Drug related toxicity
time frame: Months : 1,2,3,4,5,6,7,8,9,10,11,12
measure: opportunistic infections
time frame: Months: 1,2,3,4,5,6,7,8,9,10,11,12
measure: Direct costs
time frame: Months: 1,2,3,4,5,6,7,8,9,10,11,12
measure: Quality of life
time frame: Month 1 and end of months 4,8 and 12
arm group label: Zidovudine
arm group type: Active Comparator
description: zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
arm group label: Tenofovir
arm group type: Active Comparator
description: tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
intervention type: Drug
intervention name: Tenofovir
description: tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
arm group label: Tenofovir
other name: Atripla
other name: Vonavir
intervention type: Drug
intervention name: Zidovudine
description: zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
arm group label: Zidovudine
other name: Lazid-N
other name: Duovir-N
other name: Zidolam-N
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christine C Wanke, MD
role: Study Chair
affiliation: Tufts University
last name: Sowmyanarayanan V Thuppal, MD
role: Principal Investigator
affiliation: Tufts University
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Tufts University
investigator full name: Christine A. Wanke
investigator title: Professor of Medicine and Public Health and Community Medicine
mesh term: Tenofovir
mesh term: Zidovudine