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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus I Infection Drug Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Bictegravir/emtricitabine/tenofovir alafenamide

Intervention Type DRUG

Taking one oral tablet of B/F/TAF once-daily for 72 weeks

Interventions

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Bictegravir/emtricitabine/tenofovir alafenamide

Taking one oral tablet of B/F/TAF once-daily for 72 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No