Back to resultsSwitching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed
Primary Purpose
Human Immunodeficiency Virus I Infection, Drug Use
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Bictegravir/emtricitabine/tenofovir alafenamide
Sponsored by
About this trial
This is an interventional other trial for Human Immunodeficiency Virus I Infection
Eligibility Criteria
Inclusion Criteria:
- Participant is ≥19 years of age infected with HIV-1
Participant has an undetectable viral load <40 copies/mL at screening with any CD4 count and has exhibited any, or all of the following:
- 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…
- Participant is currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy)
- Participant has a history or current indication of illicit drug use.
- Patients infected with HCV and or HBV can be included in this study.
- 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:
- They have any documented history of integrase inhibitor resistance
They exhibit any of the following:
- Creatinine Clearance Rate < 30 ml/min
- Hemoglobin < 10.0 g/dL
- Absolute neutrophil count <750 cells/mL
- Platelet count < 50,000 /mL
- ALT or AST >5x upper limit of normal (ULN)
- Creatinine > 1.5x ULN
- They are taking medication that is contraindicated with any component of B/F/TAF.
- They are pregnant or breastfeeding.
- They do not/have not ever used any form of illicit drug use.
Sites / Locations
- Vancouver Infectious Diseases CentreRecruiting
- Victoria Cool Aid SocietyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
B/F/TAF
Arm Description
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
Outcomes
Primary Outcome Measures
The proportion of subjects that remain virally suppressed at week 48
The proportion of subjects with HIV RNA <40 copies/mL
Secondary Outcome Measures
The proportion of subjects with viral blips
Viral blips defined as detectable HIV viral load between 40-1000 copies/mL at week 72
Changes of adherence
Changes of adherence from baseline at week 2, 8, 24, 48, and 72 with an adherence questionnaire
Proportion of patients that achieved >90% adherence
Proportion of patients that achieved >90% adherence
The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF
The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF
The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72
The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72
Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module
Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module
Full Information
NCT ID
NCT04132674
First Posted
October 17, 2019
Last Updated
October 17, 2019
Sponsor
Vancouver Infectious Diseases Centre
1. Study Identification
Unique Protocol Identification Number
NCT04132674
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vancouver Infectious Diseases Centre
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus I Infection, Drug Use
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
B/F/TAF
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bictegravir/emtricitabine/tenofovir alafenamide
Intervention Description
Taking one oral tablet of B/F/TAF once-daily for 72 weeks
Primary Outcome Measure Information:
Title
The proportion of subjects that remain virally suppressed at week 48
Description
The proportion of subjects with HIV RNA <40 copies/mL
Time Frame
Interim analysis of efficacy will be done at 24 weeks
Secondary Outcome Measure Information:
Title
The proportion of subjects with viral blips
Description
Viral blips defined as detectable HIV viral load between 40-1000 copies/mL at week 72
Time Frame
Analysis will be done at 72 weeks
Title
Changes of adherence
Description
Changes of adherence from baseline at week 2, 8, 24, 48, and 72 with an adherence questionnaire
Time Frame
Analysis will be done at 72 weeks
Title
Proportion of patients that achieved >90% adherence
Description
Proportion of patients that achieved >90% adherence
Time Frame
Analysis will be done at 72 weeks
Title
The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF
Description
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
Title
The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72
Description
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
Title
Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant is ≥19 years of age infected with HIV-1
Participant has an undetectable viral load <40 copies/mL at screening with any CD4 count and has exhibited any, or all of the following:
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…
Participant is currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy)
Participant has a history or current indication of illicit drug use.
Patients infected with HCV and or HBV can be included in this study.
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:
They have any documented history of integrase inhibitor resistance
They exhibit any of the following:
Creatinine Clearance Rate < 30 ml/min
Hemoglobin < 10.0 g/dL
Absolute neutrophil count <750 cells/mL
Platelet count < 50,000 /mL
ALT or AST >5x upper limit of normal (ULN)
Creatinine > 1.5x ULN
They are taking medication that is contraindicated with any component of B/F/TAF.
They are pregnant or breastfeeding.
They do not/have not ever used any form of illicit drug use.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rossitta Yung
Phone
604-642-6429
Ext
303
Email
rossitta.yung@vidc.ca
Facility Information:
Facility Name
Vancouver Infectious Diseases Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rossitta Yung
Phone
604-642-6429
Ext
303
Email
rossitta.yung@vidc.ca
First Name & Middle Initial & Last Name & Degree
Brian Conway, MD
Facility Name
Victoria Cool Aid Society
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8W 2G2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Selfridge
Phone
250-385-1466
Email
marions@uvic.ca
First Name & Middle Initial & Last Name & Degree
Christopher Fraser, MD
12. IPD Sharing Statement
Learn more about this trial
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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