Recruiting

B/F/TAF

Sponsor:

Vancouver Infectious Diseases Centre

Code:

NCT04132674

Conditions

Human Immunodeficiency Virus I Infection

Drug Use

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Bictegravir/emtricitabine/tenofovir alafenamide

Study Details

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

Study ID

NCT04132674

Start date

Nov 26, 2018

Status verified date

Oct, 2019

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Jun 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: 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

Interventions

Bictegravir/emtricitabine/tenofovir alafenamide

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

Primary outcome measure

  • The proportion of subjects that remain virally suppressed at week 48 [ Time Frame: Interim analysis of efficacy will be done at 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

Vancouver Infectious Diseases Centre

Recruiting

Vancouver, British Columbia, Canada, V6Z 2C7

Contacts

Principal Investigator:

Brian Conway, MD

Victoria Cool Aid Society

Recruiting

Victoria, British Columbia, Canada, V8W 2G2

Contacts

Principal Investigator:

Christopher Fraser, MD

More Information

Sponsor

Vancouver Infectious Diseases Centre

Last update posted

Oct 21, 2019

Last verified

Oct, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vancouver Infectious Diseases Centre on 2019-10-21.