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Clinical Trials

MainTitle

Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women (TRANSViiV)

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2017 by Omar Sued, The Huesped Foundation

Sponsor
The Huesped Foundation

Collaborator
ViiV Healthcare

Information provided by (Responsible Party)
Omar Sued, The Huesped Foundation

ClinicalTrials.gov Identifier
NCT03033836

First received: August 18, 2016
Last updated: August 9, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : ARV treatment
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description: Single Group receiving the same intervention, to evaluate retention at 48 weeks
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women

Further study details as provided by Omar Sued, The Huesped Foundation:

Primary Outcome Measures

  • Proportion of transgender women retained in care at week 48 [ Time Frame: 48 weeks ]
    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.
Secondary Outcome Measures:
  • Proportion of individuals with HIV RNA undetectable at week 48 [ Time Frame: 48 weeks ]
    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;
  • Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality [ Time Frame: From baseline to week 48 ]
    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.
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: From baseline to week 48 ]
    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.
  • Adherence using ACTG form [ Time Frame: From baseline to week 48 ]
    ACTG self report adherence form will be used for baseline and follow up visits
  • Adherence using analogue visual scale [ Time Frame: From week 4 to week 48 ]
    Analogue visual scale (0-10) will be used at each follow up visit
  • Adherence by pill count [ Time Frame: From week 4 to week 48 ]
    Pill count of dispensed drugs
  • Quality of life [ Time Frame: From baseline to week 48 ]
    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 .
  • Patient´s satisfaction with this regimen [ Time Frame: From baseline to week 48 ]
    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 .

Estimated Enrollment: 60
Study Start Date: December 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: single arm
ARV treatment based on Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine
Drug: ARV treatment

Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.

Other Name: tivicay-truvada

Detailed Description:

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.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: Female  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

      1. HIV-1 positive serology by at least two different serological tests (rapid test, ELISA, Western Blot) or a viral load higher than 3,000 copies/mL.
      2. 18 years and older.
      3. Self-identified as TGW
      4. ART naïve.
      5. Written informed consent provided.


    Exclusion Criteria:
      1. Genotypic resistance to TDF and/or FTC as per IAS-USA resistance panel 2013.
      2. Alcohol or drug use that might affect adherence.
      3. Concomitant use of lipid-lowering drugs, interferon, interleukin-2, cytotoxic chemotherapy, dofetilide (or pilsicainide) or immunosuppressors, antacids drugs containing Ca++ and or Mg++ at study entry.
      4. Opportunistic infection (CDC "C" category) or other disease and/or clinical conditions that, in the investigator's opinion, would compromise the patient's safety or outcome of the study; including malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia.
      5. Treatment with any of the following agents within 28 days of screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses or treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening or exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of the investigational product.
      6. Contraindication to any of the study drugs (history of renal diseases, lab abnormalities grade 4 or any other clinical condition prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements).
      7. Anticipated need for Hepatitis C virus (HCV) therapy during the study.
      8. Creatinine clearance of <50 mL/min via Cockroft-Gault method.
      9. Subjects with moderate to severe hepatic impairment (Class B or greater) as determined
      by Child-Pugh classification.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT03033836

    Contacts

    Contact:   Omar Sued, MD, PhMD +54 11 4981-1855/7777 ext 113 omar.sued@huesped.org.ar
    Contact:   Maria I Figueroa, MD +54 11 4981-1855/7777 ext 114 maria.figueroa@huesped.org.ar

    Locations

    Argentina
    Fundacion Huesped Recruiting
    Ciudad de Buenos Aires, Buenos Aires, Argentina, C1202ABB
    Contact: Omar Sued, MD, Ph MD    +54 11 4981-1855/7777    omar.sued@huesped.org.ar
    Contact: Maria I Figueroa, MD    +54 11 4981-1855/7777    maria.figueroa@huesped.org.ar

    Sponsors and Collaborators

    The Huesped Foundation
    ViiV Healthcare

    Investigators

    Principal Investigator: Omar Sued, MD, PhMD Fundacion Huesped
    More Information

    More Information


    Responsible Party: Omar Sued, PhD, The Huesped Foundation  
    ClinicalTrials.gov Identifier: NCT03033836   History of Changes  
    Other Study ID Numbers: FH-17  
    Study First Received: August 18, 2016  
    Last Updated: August 9, 2017  

    Keywords provided by Omar Sued, The Huesped Foundation:

    transgender women

    Additional relevant MeSH terms:
    HIV Infections
    Tenofovir
    Lamivudine
    Emtricitabine
    Dolutegravir

    ClinicalTrials.gov processed this data on October 16, 2017
    This information is provided by ClinicalTrials.gov.