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Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed

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ClinicalTrials.gov Identifier: NCT04132674
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Vancouver Infectious Diseases Centre

Brief Summary:
In an effort to engage more HIV-infected PWUD into care, and ensure treatment adherence and efficacy, simplification of older, multi-tablet regimens is required. Newer, more potent molecules can also overcome resistant that has persisted with previous regimens, while simultaneously providing a high barrier to resistance. The co-formulation of B/F/TAF is a viable switch-option for patients who have experienced lower adherence with previous regimens due to high pill burden, or for those requiring a more potent regimen due to emergent resistances. The formal evaluation of B/F/TAF in this context will allow us to optimize care for HIV-infected PWUD.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus I Infection Drug Use Drug: Bictegravir/emtricitabine/tenofovir alafenamide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
B/F/TAF
Switching participants who are currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy) to one oral tablet of B/F/TAF once-daily for 72 weeks
Drug: Bictegravir/emtricitabine/tenofovir alafenamide
Taking one oral tablet of B/F/TAF once-daily for 72 weeks




Primary Outcome Measures :
  1. The proportion of subjects that remain virally suppressed at week 48 [ Time Frame: Interim analysis of efficacy will be done at 24 weeks ]
    The proportion of subjects with HIV RNA <40 copies/mL


Secondary Outcome Measures :
  1. The proportion of subjects with viral blips [ Time Frame: Analysis will be done at 72 weeks ]
    Viral blips defined as detectable HIV viral load between 40-1000 copies/mL at week 72

  2. Changes of adherence [ Time Frame: Analysis will be done at 72 weeks ]
    Changes of adherence from baseline at week 2, 8, 24, 48, and 72 with an adherence questionnaire

  3. Proportion of patients that achieved >90% adherence [ Time Frame: Analysis will be done at 72 weeks ]
    Proportion of patients that achieved >90% adherence

  4. The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF [ Time Frame: Analysis will be done at 72 weeks ]
    The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF

  5. The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72 [ Time Frame: Analysis will be done at 72 weeks ]
    The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72

  6. Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module [ Time Frame: Analysis will be done at 72 weeks ]
    Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant is ≥19 years of age infected with HIV-1
  2. Participant has an undetectable viral load <40 copies/mL at screening with any CD4 count and has exhibited any, or all of the following:

    1. Transient HIV viremia (episodes of HIV viral load between 40-1000 copies/mL) in the past 12 months, OR Virologic breakthrough (HIV viral load > 1000 copies/mL) in the past 12 months, OR Documented instances of non-adherence for a period of more than 7 days or…
    2. Participant is currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy)
    3. Participant has a history or current indication of illicit drug use.
    4. Patients infected with HCV and or HBV can be included in this study.
    5. If female, participant must have a negative pregnancy test and agree to use, for the duration of the study, a method of birth control that has a history of proven reliability as judged by the investigator.

Exclusion Criteria:

  1. They have any documented history of integrase inhibitor resistance
  2. They exhibit any of the following:

    1. Creatinine Clearance Rate < 30 ml/min
    2. Hemoglobin < 10.0 g/dL
    3. Absolute neutrophil count <750 cells/mL
    4. Platelet count < 50,000 /mL
    5. ALT or AST >5x upper limit of normal (ULN)
    6. Creatinine > 1.5x ULN
  3. They are taking medication that is contraindicated with any component of B/F/TAF.
  4. They are pregnant or breastfeeding.
  5. They do not/have not ever used any form of illicit drug use.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132674


Contacts
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Contact: Rossitta Yung 604-642-6429 ext 303 rossitta.yung@vidc.ca

Locations
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Canada, British Columbia
Vancouver Infectious Diseases Centre Recruiting
Vancouver, British Columbia, Canada, V6Z 2C7
Contact: Rossitta Yung    604-642-6429 ext 303    rossitta.yung@vidc.ca   
Principal Investigator: Brian Conway, MD         
Victoria Cool Aid Society Recruiting
Victoria, British Columbia, Canada, V8W 2G2
Contact: Marion Selfridge    250-385-1466    marions@uvic.ca   
Principal Investigator: Christopher Fraser, MD         
Sponsors and Collaborators
Vancouver Infectious Diseases Centre

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Responsible Party: Vancouver Infectious Diseases Centre
ClinicalTrials.gov Identifier: NCT04132674     History of Changes
Other Study ID Numbers: Biktarvy Study
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents