Clinical trial NCT04132674: Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Human Immunodeficiency Virus I Infection
Drug Use
Lead sponsor: Vancouver Infectious Diseases Centre
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of subjects that remain virally suppressed at week 48
timeFrame: Interim analysis of efficacy will be done at 24 weeks
Secondary outcomes:
measure: The proportion of subjects with viral blips
timeFrame: Analysis will be done at 72 weeks
measure: Changes of adherence
timeFrame: Analysis will be done at 72 weeks
measure: Proportion of patients that achieved >90% adherence
timeFrame: Analysis will be done at 72 weeks
measure: The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF
timeFrame: Analysis will be done at 72 weeks
measure: The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72
timeFrame: Analysis will be done at 72 weeks
measure: Changes to baseline quality of life at week 4, 12, 36, 60, and 72 using the HIV Symptoms Distress Module
timeFrame: Analysis will be done at 72 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Infectious Diseases Centre
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Cool Aid Society
state: British Columbia
Study officials:
References: