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

Phase 4

• Conditions: Human Immunodeficiency Virus I Infection; Drug Use
• Interventions: Drug: Bictegravir/emtricitabine/tenofovir alafenamide

• Registration Number: NCT04132674
• Lead Sponsor: Vancouver Infectious Diseases Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-26
• Status Verified: 2019-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-17
• Last Update Submitted: 2019-10-17
• Study First Posted: 2019-10-21
• Last Update Posted: 2019-10-21
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B/F/TAF	Bictegravir/emtricitabine/tenofovir alafenamide	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

Primary Outcome Measures

Name	Time	Method
The proportion of subjects that remain virally suppressed at week 48	Interim analysis of efficacy will be done at 24 weeks	The proportion of subjects with HIV RNA \<40 copies/mL

Secondary Outcome Measures

Name	Time	Method
Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module	Analysis will be done at 72 weeks	Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module
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 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	Analysis will be done at 72 weeks	The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72
The proportion of subjects with viral blips	Analysis will be done at 72 weeks	Viral blips defined as detectable HIV viral load between 40-1000 copies/mL at week 72
Changes of adherence	Analysis will be done at 72 weeks	Changes of adherence from baseline at week 2, 8, 24, 48, and 72 with an adherence questionnaire
Proportion of patients that achieved >90% adherence	Analysis will be done at 72 weeks	Proportion of patients that achieved \>90% adherence

Trial Locations

Locations (2)

Vancouver Infectious Diseases Centre; 🇨🇦 Vancouver, British Columbia, Canada

Victoria Cool Aid Society; 🇨🇦 Victoria, British Columbia, Canada