Status:
UNKNOWN
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed
Lead Sponsor:
Vancouver Infectious Diseases Centre
Conditions:
Human Immunodeficiency Virus I Infection
Drug Use
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04132674
Start Date
November 26 2018
End Date
December 31 2020
Last Update
October 21 2019
Active Locations (2)
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1
Vancouver Infectious Diseases Centre
Vancouver, British Columbia, Canada, V6Z 2C7
2
Victoria Cool Aid Society
Victoria, British Columbia, Canada, V8W 2G2