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

NCT04132674 | Unknown Phase 4 FDA Drug

• 1 other identifier: Biktarvy Study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Human Immunodeficiency Virus I Infection; Drug Use

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects that remain virally suppressed at week 48

  The proportion of subjects with HIV RNA \<40 copies/mL

  Interim analysis of efficacy will be done at 24 weeks

Secondary Outcomes (6)

• The proportion of subjects with viral blips

  Analysis will be done at 72 weeks

• Changes of adherence

  Analysis will be done at 72 weeks

• Proportion of patients that achieved >90% adherence

  Analysis will be done at 72 weeks

• The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF

  Analysis will be done at 72 weeks

• The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72

  Analysis will be done at 72 weeks

Study Arms (1)

B/F/TAF

OTHER

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

Interventions

Bictegravir/emtricitabine/tenofovir alafenamide DRUG

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

B/F/TAF

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vancouver Infectious Diseases Centre: lead

Study Sites (2)

Vancouver Infectious Diseases Centre

Vancouver, British Columbia, V6Z 2C7, Canada

RECRUITING

Victoria Cool Aid Society

Victoria, British Columbia, V8W 2G2, Canada

RECRUITING

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Central Study Contacts

Rossitta Yung

CONTACT

604-642-6429; rossitta.yung@vidc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: November 26, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

CA (2)