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

Drug Use Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04132674
• Other study ID #: Biktarvy Study
• Status: Recruiting
• Phase: Phase 4
• Start date: November 26, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2019
• Source: Vancouver Infectious Diseases Centre
• Contact: Rossitta Yung
• Phone: 604-642-6429
• Email: rossitta.yung[@]vidc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Drug Use
• HIV Infections
• Human Immunodeficiency Virus I Infection

Intervention

Drug:
• Bictegravir/emtricitabine/tenofovir alafenamide
Taking one oral tablet of B/F/TAF once-daily for 72 weeks

Locations

Country	Name	City	State
Canada	Vancouver Infectious Diseases Centre	Vancouver	British Columbia
Canada	Victoria Cool Aid Society	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vancouver Infectious Diseases Centre

Country where clinical trial is conducted

Canada, 

Outcome

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