<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/NCT03789968</url>
  </required_header>
  <id_info>
    <org_study_id>18G.786</org_study_id>
    <nct_id>NCT03789968</nct_id>
  </id_info>
  <brief_title>The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients</brief_title>
  <official_title>The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Maryland, College Park</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Indiana University Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Brooklyn Hospital Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nova Southeastern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess changes in the incidence and severity of drug interactions before and&#xD;
      after switching antiretroviral therapy to bictegravir/emtricitabine/tenofovir&#xD;
      alafenamide-based regimens in treatment experienced patients living with HIV infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Simple, safe and effective antiretroviral therapy (ART) can provide optimal treatment&#xD;
      outcomes for people living with HIV infection (PLWH) [1]. Increasingly complex and poorly&#xD;
      tolerated regimens, on the other hand often limit ART adherence, while drug-drug interactions&#xD;
      (DDIs) and safety concerns with individual ART agents can limit treatment selection [2-4].&#xD;
      Fortunately, recent advances in ART have included the emergence of several highly effective,&#xD;
      safe and well tolerated regimens with limited DDIs. In clinical trials, integrase strand&#xD;
      transfer inhibitors (INSTIs) such as raltegravir, elvitegravir, dolutegravir and bictegravir&#xD;
      are consistently as effective or more effective than comparator agents and often superior in&#xD;
      terms of tolerability [5-10]. Due to their efficacy, safety, and tolerability, INSTI-based&#xD;
      regimens are now routinely used in treatment naïve patients and emerging data suggests that&#xD;
      several may be used to simplify therapy for selected patients with treatment experience [11,&#xD;
      12].&#xD;
&#xD;
      Among the INSTIs, bictegravir is the newest agent in the class [13]. Similar to dolutegravir&#xD;
      and raltegravir and in contrast to elvitegravir, it has few significant drug-drug&#xD;
      interactions. Unlike dolutegravir and raltegravir, bictegravir is available as part of a&#xD;
      single-tablet, once-daily regimen that includes tenofovir alafenamide and emtricitabine&#xD;
      (BIC/TAF/FTC). Raltegravir is not available within a single tablet regimen, while&#xD;
      dolutegravir is available as part of a single-tablet regimen, but it includes abacavir, which&#xD;
      has been linked to an increased cardiovascular disease risk. As a result, BIC/TAF/FTC is&#xD;
      currently among the most effective, safe, well-tolerated treatment options with limited&#xD;
      drug-drug interactions.&#xD;
&#xD;
      With several new treatment options available, particularly in the INSTI class, current&#xD;
      guidelines advocate switching ART when possible in virologically suppressed, ART experienced&#xD;
      patients [1]. Switching ART can simplify treatment, improve tolerability, eliminate toxicity,&#xD;
      and mitigate drug-drug interactions. When switching ART for any reason, it is critical to&#xD;
      review a patient's full HIV treatment history, including virologic responses, past&#xD;
      ART-associated toxicities, and cumulative resistance before selecting a new regimen [1].&#xD;
&#xD;
      Drug-drug interaction assessments with a patient's concomitant medications should also be&#xD;
      performed prior to switching ART. More than 70% of the HIV population will be above the age&#xD;
      of 50 by the year 2020 and many are receiving 5 or more medications for common chronic&#xD;
      conditions in addition to being ART experienced [14, 15]. Cardiovascular disease, hepatic and&#xD;
      renal disease, osteoporosis, insulin resistance, metabolic disorders, and cancers are among&#xD;
      the conditions that can occur more commonly in PLWH and at times earlier in life in&#xD;
      comparison to their HIV negative counterparts [16]. Drug-drug interactions between&#xD;
      medications needed to treat or prevent these comorbid conditions can often interact with ART.&#xD;
      Switching ART, in many circumstances can reduce the number drug interactions with medications&#xD;
      for comorbid conditions. Conversely, switching can also lead to new interactions requiring&#xD;
      intervention to avoid toxicities or prevent ineffective treatment.&#xD;
&#xD;
      Multiple studies have confirmed that switching HIV treatment can improve patient adherence&#xD;
      and quality of life [17]. Several studies have also confirmed that clinically significant&#xD;
      drug-drug interactions are common in patients living with HIV, but none have assessed changes&#xD;
      in the incidence and severity of drug-drug interactions in the setting of ART switches&#xD;
      [18-20]. The primary objective of this study is to assess changes in the incidence and&#xD;
      severity of drug interactions before and after switching ART to BIC/TAF/FTC -based regimens&#xD;
      in treatment experienced patients.&#xD;
&#xD;
      Null Hypothesis:&#xD;
&#xD;
      There is no difference in the incidence and severity of drug-drug interactions between ART&#xD;
      and concomitant medications before and after switching to a BIC/TAF/FTC-based ART regimen in&#xD;
      treatment experienced patients.&#xD;
&#xD;
      Alternative Hypothesis:&#xD;
&#xD;
      The incidence and severity of drug-drug interactions between ART and concomitant medications&#xD;
      is reduced after switching to a BIC/TAF/FTC-based ART regimen in treatment experienced&#xD;
      patients.&#xD;
&#xD;
      Data Collection Subjects from the Jefferson Infectious Diseases Associates outpatient HIV&#xD;
      Clinic will be evaluated for study inclusion. Co-investigators at six partner institutions&#xD;
      will also evaluate patients at their HIV clinics for study inclusion. The following&#xD;
      information will be collected for patients meeting the study criteria: age, gender, race,&#xD;
      duration of HIV infection, duration of ART treatment, number of previous ART regimens, CD4+&#xD;
      cell count and HIV RNA directly prior to switching to a BIC/TAF/FTC-based ART regimen, and&#xD;
      the reason for switching ART to a BIC/TAF/FTC-based regimen. Additionally, all concomitant&#xD;
      medication names at the time of the ART switch will be collected.&#xD;
&#xD;
      Scoring System To assess the combined incidence and severity of drug interactions with&#xD;
      concomitant medications (CM) prior to and following each patient's ART switch, a DDI&#xD;
      incidence and severity score was developed. The score is based upon results obtained when&#xD;
      entering medications into the University of Liverpool's HIV Drug Interaction Checker (ULHDIC)&#xD;
      database [21]. Each ART-CM pair is given one of the following scores: &quot;do not co-administer&quot;&#xD;
      is assigned a score of 2, &quot;potential interaction&quot; a score of 1, and &quot;potential weak&#xD;
      interaction&quot; or &quot;no interaction&quot; a score of 0. For those interactions that have &quot;no clear&#xD;
      data,&quot; or for those medications that are not listed in the drug database, the Department of&#xD;
      Health and Human Services HIV treatment guidelines will be consulted along with the FDA&#xD;
      product labeling.&#xD;
&#xD;
      Score Validation A separate analysis (data not provided here) was completed by study&#xD;
      investigators to validate the use of the ULDIC severity ranking. The medication profiles of a&#xD;
      random, representative sample of the study's population were selected for analysis. Drug&#xD;
      interaction scores using the aforementioned ULHDIC were compared with drug interaction scores&#xD;
      determined manually using the Department of Health and Human Services HIV treatment&#xD;
      guidelines and FDA product labeling. No statistical difference in drug interaction scores&#xD;
      between methods was observed.&#xD;
&#xD;
      Primary Endpoint The primary endpoint of the study will be to measure the change in mean&#xD;
      total drug interaction scores pre and post ART switch to a BIC/TAF/FTC-based ART regimen. The&#xD;
      total drug interaction scores for each patient pre- and post-switch will be calculated. The&#xD;
      average pre-switch and post-switch scores will then be determined and analyzed for&#xD;
      statistical differences using a two-sided paired t-test (normal distribution) with an alpha&#xD;
      level of 0.05 or a Wilcoxon Ranked Sum test (non-normal distribution).&#xD;
&#xD;
      Secondary Endpoints The secondary endpoint of the study will be to identify predictors of&#xD;
      achieving drug interaction score reductions after switching to a BIC/TAF/FTC-based ART&#xD;
      regimen. Predictors for achieving drug interaction score reductions will be examined using a&#xD;
      multivariable linear regression model. Initial models will include all a priori determined&#xD;
      variables and all variables will be examined for multi-collinearity. Models will be fit using&#xD;
      a backwards selection procedure. Candidate predictors will be eliminated individually by&#xD;
      comparing the log likelihood ratio test for each model step and using the 5% significance&#xD;
      level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">October 5, 2020</completion_date>
  <primary_completion_date type="Actual">September 5, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in drug interactions after switching to bictegravir/emtricitabine/tenofovir alafenamide</measure>
    <time_frame>1 year</time_frame>
    <description>The primary endpoint is to measure the change in mean total drug interaction scores pre and post ART switch to a bictegravir/emtricitabine/tenofovir alafenamide-based regimen. The total drug interaction scores for each patient pre- and post-switch will be calculated using a drug interaction score developed for this study. The score is obtained when entering a patient's ART and concomitant medications (CM) into the University of Liverpool's HIV Drug Interaction Checker database [21]. Each ART-CM pair is given one of the following scores: &quot;do not co-administer&quot; is a score of 2, &quot;potential interaction&quot; a score of 1, and &quot;potential weak interaction&quot; or &quot;no interaction&quot; a score of 0. When no interactions are observed between a patient's ART and CMs, the total score will be 0. Higher scores occur when interactions are present. A decrease in score indicates that switching to bictegravir/emtricitabine/tenofovir alafenamide decreased the number and severity of interactions present.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictors of achieving drug interaction score reductions after switching to bictegravir/emtricitabine/tenofovir alafenamide</measure>
    <time_frame>1 year</time_frame>
    <description>The secondary endpoint of the study is to identify predictors of drug interaction score reductions after switching to a bictegravir/emtricitabine/tenofovir alafenamide. Predictors will be examined using multivariable linear regression. Initial models will include all a priori variables which will be examined for multi-collinearity. Models will be fit using a backwards selection procedure. Candidate predictors will be eliminated individually by comparing the log likelihood ratio test for each model step and using the 5% significance level.</description>
  </secondary_outcome>
  <enrollment type="Actual">411</enrollment>
  <condition>HIV/AIDS</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bictegravir/emtricitabine/tenofovir alafenamide</intervention_name>
    <description>Treatment experienced patients with HIV infection that switched to a bictegravir/emtricitabine/tenofovir alafenamide-based ART regimen</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults living with HIV infection and receiving antiretroviral therapy who have changed&#xD;
        treatments to bictegravir/emtricitabine/tenofovir alafenamide&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. HIV diagnosis&#xD;
&#xD;
          2. 18 years of age or older&#xD;
&#xD;
          3. Receiving ART for at least 3 months&#xD;
&#xD;
          4. ART is switched to bictegravir/emtricitabine/tenofovir alafenamide between 2/7/2018&#xD;
             and 3/30/2019&#xD;
&#xD;
          5. Patient is receiving at least one chronic or as needed non-ART medication at the time&#xD;
             of the switch&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason J Schafer, PharmD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.hiv-druginteractions.org/</url>
    <description>HIV Drug Interactions. University of Liverpool.</description>
  </link>
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  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thomas Jefferson University</investigator_affiliation>
    <investigator_full_name>Jason Schafer</investigator_full_name>
    <investigator_title>Associate Professor, Department of Pharmacy</investigator_title>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Emtricitabine</mesh_term>
    <mesh_term>Emtricitabine tenofovir alafenamide</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/NCT03789968
org study id: 18G.786
nct id: NCT03789968
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will assess changes in the incidence and severity of drug interactions before and
      after switching antiretroviral therapy to bictegravir/emtricitabine/tenofovir
      alafenamide-based regimens in treatment experienced patients living with HIV infection.
Simple, safe and effective antiretroviral therapy (ART) can provide optimal treatment
      outcomes for people living with HIV infection (PLWH) [1]. Increasingly complex and poorly
      tolerated regimens, on the other hand often limit ART adherence, while drug-drug interactions
      (DDIs) and safety concerns with individual ART agents can limit treatment selection [2-4].
      Fortunately, recent advances in ART have included the emergence of several highly effective,
      safe and well tolerated regimens with limited DDIs. In clinical trials, integrase strand
      transfer inhibitors (INSTIs) such as raltegravir, elvitegravir, dolutegravir and bictegravir
      are consistently as effective or more effective than comparator agents and often superior in
      terms of tolerability [5-10]. Due to their efficacy, safety, and tolerability, INSTI-based
      regimens are now routinely used in treatment naïve patients and emerging data suggests that
      several may be used to simplify therapy for selected patients with treatment experience [11,
      12].

      Among the INSTIs, bictegravir is the newest agent in the class [13]. Similar to dolutegravir
      and raltegravir and in contrast to elvitegravir, it has few significant drug-drug
      interactions. Unlike dolutegravir and raltegravir, bictegravir is available as part of a
      single-tablet, once-daily regimen that includes tenofovir alafenamide and emtricitabine
      (BIC/TAF/FTC). Raltegravir is not available within a single tablet regimen, while
      dolutegravir is available as part of a single-tablet regimen, but it includes abacavir, which
      has been linked to an increased cardiovascular disease risk. As a result, BIC/TAF/FTC is
      currently among the most effective, safe, well-tolerated treatment options with limited
      drug-drug interactions.

      With several new treatment options available, particularly in the INSTI class, current
      guidelines advocate switching ART when possible in virologically suppressed, ART experienced
      patients [1]. Switching ART can simplify treatment, improve tolerability, eliminate toxicity,
      and mitigate drug-drug interactions. When switching ART for any reason, it is critical to
      review a patient's full HIV treatment history, including virologic responses, past
      ART-associated toxicities, and cumulative resistance before selecting a new regimen [1].

      Drug-drug interaction assessments with a patient's concomitant medications should also be
      performed prior to switching ART. More than 70% of the HIV population will be above the age
      of 50 by the year 2020 and many are receiving 5 or more medications for common chronic
      conditions in addition to being ART experienced [14, 15]. Cardiovascular disease, hepatic and
      renal disease, osteoporosis, insulin resistance, metabolic disorders, and cancers are among
      the conditions that can occur more commonly in PLWH and at times earlier in life in
      comparison to their HIV negative counterparts [16]. Drug-drug interactions between
      medications needed to treat or prevent these comorbid conditions can often interact with ART.
      Switching ART, in many circumstances can reduce the number drug interactions with medications
      for comorbid conditions. Conversely, switching can also lead to new interactions requiring
      intervention to avoid toxicities or prevent ineffective treatment.

      Multiple studies have confirmed that switching HIV treatment can improve patient adherence
      and quality of life [17]. Several studies have also confirmed that clinically significant
      drug-drug interactions are common in patients living with HIV, but none have assessed changes
      in the incidence and severity of drug-drug interactions in the setting of ART switches
      [18-20]. The primary objective of this study is to assess changes in the incidence and
      severity of drug interactions before and after switching ART to BIC/TAF/FTC -based regimens
      in treatment experienced patients.

      Null Hypothesis:

      There is no difference in the incidence and severity of drug-drug interactions between ART
      and concomitant medications before and after switching to a BIC/TAF/FTC-based ART regimen in
      treatment experienced patients.

      Alternative Hypothesis:

      The incidence and severity of drug-drug interactions between ART and concomitant medications
      is reduced after switching to a BIC/TAF/FTC-based ART regimen in treatment experienced
      patients.

      Data Collection Subjects from the Jefferson Infectious Diseases Associates outpatient HIV
      Clinic will be evaluated for study inclusion. Co-investigators at six partner institutions
      will also evaluate patients at their HIV clinics for study inclusion. The following
      information will be collected for patients meeting the study criteria: age, gender, race,
      duration of HIV infection, duration of ART treatment, number of previous ART regimens, CD4+
      cell count and HIV RNA directly prior to switching to a BIC/TAF/FTC-based ART regimen, and
      the reason for switching ART to a BIC/TAF/FTC-based regimen. Additionally, all concomitant
      medication names at the time of the ART switch will be collected.

      Scoring System To assess the combined incidence and severity of drug interactions with
      concomitant medications (CM) prior to and following each patient's ART switch, a DDI
      incidence and severity score was developed. The score is based upon results obtained when
      entering medications into the University of Liverpool's HIV Drug Interaction Checker (ULHDIC)
      database [21]. Each ART-CM pair is given one of the following scores: "do not co-administer"
      is assigned a score of 2, "potential interaction" a score of 1, and "potential weak
      interaction" or "no interaction" a score of 0. For those interactions that have "no clear
      data," or for those medications that are not listed in the drug database, the Department of
      Health and Human Services HIV treatment guidelines will be consulted along with the FDA
      product labeling.

      Score Validation A separate analysis (data not provided here) was completed by study
      investigators to validate the use of the ULDIC severity ranking. The medication profiles of a
      random, representative sample of the study's population were selected for analysis. Drug
      interaction scores using the aforementioned ULHDIC were compared with drug interaction scores
      determined manually using the Department of Health and Human Services HIV treatment
      guidelines and FDA product labeling. No statistical difference in drug interaction scores
      between methods was observed.

      Primary Endpoint The primary endpoint of the study will be to measure the change in mean
      total drug interaction scores pre and post ART switch to a BIC/TAF/FTC-based ART regimen. The
      total drug interaction scores for each patient pre- and post-switch will be calculated. The
      average pre-switch and post-switch scores will then be determined and analyzed for
      statistical differences using a two-sided paired t-test (normal distribution) with an alpha
      level of 0.05 or a Wilcoxon Ranked Sum test (non-normal distribution).

      Secondary Endpoints The secondary endpoint of the study will be to identify predictors of
      achieving drug interaction score reductions after switching to a BIC/TAF/FTC-based ART
      regimen. Predictors for achieving drug interaction score reductions will be examined using a
      multivariable linear regression model. Initial models will include all a priori determined
      variables and all variables will be examined for multi-collinearity. Models will be fit using
      a backwards selection procedure. Candidate predictors will be eliminated individually by
      comparing the log likelihood ratio test for each model step and using the 5% significance
      level.
observational model: Cohort
time perspective: Retrospective
measure: Changes in drug interactions after switching to bictegravir/emtricitabine/tenofovir alafenamide
time frame: 1 year
description: The primary endpoint is to measure the change in mean total drug interaction scores pre and post ART switch to a bictegravir/emtricitabine/tenofovir alafenamide-based regimen. The total drug interaction scores for each patient pre- and post-switch will be calculated using a drug interaction score developed for this study. The score is obtained when entering a patient's ART and concomitant medications (CM) into the University of Liverpool's HIV Drug Interaction Checker database [21]. Each ART-CM pair is given one of the following scores: "do not co-administer" is a score of 2, "potential interaction" a score of 1, and "potential weak interaction" or "no interaction" a score of 0. When no interactions are observed between a patient's ART and CMs, the total score will be 0. Higher scores occur when interactions are present. A decrease in score indicates that switching to bictegravir/emtricitabine/tenofovir alafenamide decreased the number and severity of interactions present.
measure: Predictors of achieving drug interaction score reductions after switching to bictegravir/emtricitabine/tenofovir alafenamide
time frame: 1 year
description: The secondary endpoint of the study is to identify predictors of drug interaction score reductions after switching to a bictegravir/emtricitabine/tenofovir alafenamide. Predictors will be examined using multivariable linear regression. Initial models will include all a priori variables which will be examined for multi-collinearity. Models will be fit using a backwards selection procedure. Candidate predictors will be eliminated individually by comparing the log likelihood ratio test for each model step and using the 5% significance level.
intervention type: Drug
intervention name: bictegravir/emtricitabine/tenofovir alafenamide
description: Treatment experienced patients with HIV infection that switched to a bictegravir/emtricitabine/tenofovir alafenamide-based ART regimen
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jason J Schafer, PharmD, MPH
role: Principal Investigator
affiliation: Thomas Jefferson University
facility: 
country: United States
url: https://www.hiv-druginteractions.org/
description: HIV Drug Interactions. University of Liverpool.
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responsible party type: Principal Investigator
investigator affiliation: Thomas Jefferson University
investigator full name: Jason Schafer
investigator title: Associate Professor, Department of Pharmacy
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Emtricitabine tenofovir alafenamide
sharing ipd: No