<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/NCT03033836</url>
  </required_header>
  <id_info>
    <org_study_id>FH-17</org_study_id>
    <nct_id>NCT03033836</nct_id>
  </id_info>
  <brief_title>Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women</brief_title>
  <acronym>TRANSViiV</acronym>
  <official_title>Pilot Study of Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Huésped</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ViiV Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación Huésped</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, open, single-arm trial of dolutegravir-tenofovir and emtricitabine or lamivudine&#xD;
      (DTG-TDF-FTC or 3TC) in antiretroviral (ART) naïve HIV transgender women (TGW).&#xD;
&#xD;
      The primary objective of this pilot study is to determine the retention in care of TGW&#xD;
      treated with DTG-TDF-FTC or 3TC&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  To evaluate the efficacy of the antiretroviral regimen at week 48 ;&#xD;
&#xD;
        -  To describe the safety and tolerability of this regimen;&#xD;
&#xD;
        -  To evaluate adherence across 48 weeks;&#xD;
&#xD;
        -  To determine the patient satisfaction with this regimen;&#xD;
&#xD;
        -  To identify individual, social and contextual factors associated with adherence and&#xD;
           retention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this pilot study is to determine the retention in care of TGW&#xD;
      treated with DTG-TDF-FTC.&#xD;
&#xD;
      The primary objective will be assessed by the proportion of individuals that provide&#xD;
      information on ART use and virological outcomes at the end of the study:&#xD;
&#xD;
        -  Retention under care: Proportion of enrolled and dosed individuals that provide clinical&#xD;
           information up to 48 weeks of follow up.&#xD;
&#xD;
        -  Retention on treatment: Proportion of enrolled and dosed individuals that receive study&#xD;
           drugs up to 48 weeks of follow up.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  To evaluate the efficacy of the antiretroviral regimen at week 48 ;&#xD;
&#xD;
        -  To describe the safety and tolerability of this regimen;&#xD;
&#xD;
        -  To evaluate adherence across 48 weeks;&#xD;
&#xD;
        -  To determine the patient satisfaction with this regimen;&#xD;
&#xD;
        -  To identify individual, social and contextual factors associated with adherence and&#xD;
           retention.&#xD;
&#xD;
      The secondary objectives will be evaluated using the following endpoints:&#xD;
&#xD;
        1. Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at 48 weeks of&#xD;
           treatment by the IIT-exposed snapshot FDA algorithm;&#xD;
&#xD;
        2. Frequency, type and severity of adverse events and laboratory abnormalities;&#xD;
&#xD;
        3. Pill count, analogue visual scale for adherence in each visit;&#xD;
&#xD;
        4. Changes in the scores of stigma and discrimination scales , quality of life, social&#xD;
           support and anxiety and depression (BERGER, WBI,DUKE,CES-D,STAI) at bsl, 4,24, and 48&#xD;
           weeks e;.Changes in the score scales of sexual behaviors, use of drug /alcohol at bsl&#xD;
           and at each visit .&#xD;
&#xD;
      f. Through association of baseline individual, social and contextual characteristics with&#xD;
      percentage of adherence and retention at 48 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">June 28, 2019</completion_date>
  <primary_completion_date type="Actual">June 28, 2019</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>
    <intervention_model_description>Single Group receiving the same intervention, to evaluate retention at 48 weeks</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of transgender women retained in care at week 48</measure>
    <time_frame>48 weeks</time_frame>
    <description>Proportion of enrolled and dosed individuals that complete protocol defined visits during 48 weeks of follow up.&#xD;
Retention under care: Proportion of enrolled and dosed individuals that provide clinical information up to 48 weeks of follow up.&#xD;
Retention on treatment: Proportion of enrolled and dosed individuals that receive study drugs up to 48 weeks of follow up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of individuals with HIV RNA undetectable at week 48</measure>
    <time_frame>48 weeks</time_frame>
    <description>Proportion of patients with HIV-1 RNA levels less than 50 copies/mL at week 48 weeks of treatment by the IIT-exposed snapshot FDA algorithm;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality</measure>
    <time_frame>From baseline to week 48</time_frame>
    <description>Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Treatment-Emergent Adverse Events</measure>
    <time_frame>From baseline to week 48</time_frame>
    <description>Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence using ACTG form</measure>
    <time_frame>From baseline to week 48</time_frame>
    <description>ACTG self report adherence form will be used for baseline and follow up visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence using analogue visual scale</measure>
    <time_frame>From week 4 to week 48</time_frame>
    <description>Analogue visual scale (0-10) will be used at each follow up visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence by pill count</measure>
    <time_frame>From week 4 to week 48</time_frame>
    <description>Pill count of dispensed drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life by QoL Socre and Well being index</measure>
    <time_frame>From baseline to week 48</time_frame>
    <description>Changes in the scores of quality of life, will be done through Well-being Index questionnaire, this instrument will be administered to patients at baseline, week 4, 24 and week 48 .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient´s satisfaction with this regimen</measure>
    <time_frame>From baseline to week 48</time_frame>
    <description>Changes in the scores of social support,will be done through Duke UNC questionnaire, this instrument will be administered to patients at baseline, week 4, 24 and week 48 .</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ARV treatment</intervention_name>
    <description>Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.</description>
    <arm_group_label>single arm</arm_group_label>
    <other_name>tivicay-truvada</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. HIV-1 positive serology by at least two different serological tests (rapid test,&#xD;
             ELISA, Western Blot) or a viral load higher than 3,000 copies/mL.&#xD;
&#xD;
          2. 18 years and older.&#xD;
&#xD;
          3. Self-identified as TGW&#xD;
&#xD;
          4. ART naïve.&#xD;
&#xD;
          5. Written informed consent provided.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Genotypic resistance to TDF and/or FTC as per IAS-USA resistance panel 2013.&#xD;
&#xD;
          2. Alcohol or drug use that might affect adherence.&#xD;
&#xD;
          3. Concomitant use of lipid-lowering drugs, interferon, interleukin-2, cytotoxic&#xD;
             chemotherapy, dofetilide (or pilsicainide) or immunosuppressors, antacids drugs&#xD;
             containing Ca++ and or Mg++ at study entry.&#xD;
&#xD;
          4. Opportunistic infection (CDC &quot;C&quot; category) or other disease and/or clinical conditions&#xD;
             that, in the investigator's opinion, would compromise the patient's safety or outcome&#xD;
             of the study; including malignancy other than cutaneous Kaposi's sarcoma, basal cell&#xD;
             carcinoma, or non-invasive cutaneous squamous cell carcinoma, or cervical&#xD;
             intraepithelial neoplasia.&#xD;
&#xD;
          5. Treatment with any of the following agents within 28 days of screening: radiation&#xD;
             therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune&#xD;
             responses or treatment with an HIV-1 immunotherapeutic vaccine within 90 days of&#xD;
             screening or exposure to an experimental drug or experimental vaccine within either 28&#xD;
             days, 5 half-lives of the test agent, or twice the duration of the biological effect&#xD;
             of the test agent, whichever is longer, prior to the first dose of the investigational&#xD;
             product.&#xD;
&#xD;
          6. Contraindication to any of the study drugs (history of renal diseases, lab&#xD;
             abnormalities grade 4 or any other clinical condition prior therapy that, in the&#xD;
             opinion of the investigator, would make the subject unsuitable for the study or unable&#xD;
             to comply with the dosing requirements).&#xD;
&#xD;
          7. Anticipated need for Hepatitis C virus (HCV) therapy during the study.&#xD;
&#xD;
          8. Creatinine clearance of &lt;50 mL/min via Cockroft-Gault method.&#xD;
&#xD;
          9. Subjects with moderate to severe hepatic impairment (Class B or greater) as determined&#xD;
             by Child-Pugh classification.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Omar Sued, MD, PhMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundacion Huesped</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fundacion Huesped</name>
      <address>
        <city>Ciudad de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1202ABB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 18, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>August 7, 2019</last_update_submitted>
  <last_update_submitted_qc>August 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación Huésped</investigator_affiliation>
    <investigator_full_name>Omar Sued</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>transgender women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
    <mesh_term>Dolutegravir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>to publish study results</ipd_description>
  </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/NCT03033836
org study id: FH-17
nct id: NCT03033836
lead sponsor: 
collaborator: 
has dmc: No
Prospective, open, single-arm trial of dolutegravir-tenofovir and emtricitabine or lamivudine
      (DTG-TDF-FTC or 3TC) in antiretroviral (ART) naïve HIV transgender women (TGW).

      The primary objective of this pilot study is to determine the retention in care of TGW
      treated with DTG-TDF-FTC or 3TC

      Secondary objectives:

        -  To evaluate the efficacy of the antiretroviral regimen at week 48 ;

        -  To describe the safety and tolerability of this regimen;

        -  To evaluate adherence across 48 weeks;

        -  To determine the patient satisfaction with this regimen;

        -  To identify individual, social and contextual factors associated with adherence and
           retention.
The primary objective of this pilot study is to determine the retention in care of TGW
      treated with DTG-TDF-FTC.

      The primary objective will be assessed by the proportion of individuals that provide
      information on ART use and virological outcomes at the end of the study:

        -  Retention under care: Proportion of enrolled and dosed individuals that provide clinical
           information up to 48 weeks of follow up.

        -  Retention on treatment: Proportion of enrolled and dosed individuals that receive study
           drugs up to 48 weeks of follow up.

      Secondary objectives:

        -  To evaluate the efficacy of the antiretroviral regimen at week 48 ;

        -  To describe the safety and tolerability of this regimen;

        -  To evaluate adherence across 48 weeks;

        -  To determine the patient satisfaction with this regimen;

        -  To identify individual, social and contextual factors associated with adherence and
           retention.

      The secondary objectives will be evaluated using the following endpoints:

        1. Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at 48 weeks of
           treatment by the IIT-exposed snapshot FDA algorithm;

        2. Frequency, type and severity of adverse events and laboratory abnormalities;

        3. Pill count, analogue visual scale for adherence in each visit;

        4. Changes in the scores of stigma and discrimination scales , quality of life, social
           support and anxiety and depression (BERGER, WBI,DUKE,CES-D,STAI) at bsl, 4,24, and 48
           weeks e;.Changes in the score scales of sexual behaviors, use of drug /alcohol at bsl
           and at each visit .

      f. Through association of baseline individual, social and contextual characteristics with
      percentage of adherence and retention at 48 weeks.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Group receiving the same intervention, to evaluate retention at 48 weeks
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of transgender women retained in care at week 48
time frame: 48 weeks
description: Proportion of enrolled and dosed individuals that complete protocol defined visits during 48 weeks of follow up.
Retention under care: Proportion of enrolled and dosed individuals that provide clinical information up to 48 weeks of follow up.
Retention on treatment: Proportion of enrolled and dosed individuals that receive study drugs up to 48 weeks of follow up.
measure: Proportion of individuals with HIV RNA undetectable at week 48
time frame: 48 weeks
description: Proportion of patients with HIV-1 RNA levels less than 50 copies/mL at week 48 weeks of treatment by the IIT-exposed snapshot FDA algorithm;
measure: Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
time frame: From baseline to week 48
description: Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events
time frame: From baseline to week 48
description: Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
measure: Adherence using ACTG form
time frame: From baseline to week 48
description: ACTG self report adherence form will be used for baseline and follow up visits
measure: Adherence using analogue visual scale
time frame: From week 4 to week 48
description: Analogue visual scale (0-10) will be used at each follow up visit
measure: Adherence by pill count
time frame: From week 4 to week 48
description: Pill count of dispensed drugs
measure: Quality of life by QoL Socre and Well being index
time frame: From baseline to week 48
description: Changes in the scores of quality of life, will be done through Well-being Index questionnaire, this instrument will be administered to patients at baseline, week 4, 24 and week 48 .
measure: Patient´s satisfaction with this regimen
time frame: From baseline to week 48
description: Changes in the scores of social support,will be done through Duke UNC questionnaire, this instrument will be administered to patients at baseline, week 4, 24 and week 48 .
arm group label: single arm
arm group type: Experimental
description: ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine
intervention type: Drug
intervention name: ARV treatment
description: Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.
arm group label: single arm
other name: tivicay-truvada
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Omar Sued, MD, PhMD
role: Principal Investigator
affiliation: Fundacion Huesped
facility: 
country: Argentina
responsible party type: Principal Investigator
investigator affiliation: Fundación Huésped
investigator full name: Omar Sued
investigator title: PhD
mesh term: HIV Infections
mesh term: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
mesh term: Dolutegravir
sharing ipd: Yes
ipd description: to publish study results