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

• Sponsor: Vancouver Infectious Diseases Centre (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04132674
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 25.2
• Patients Per Site: 20
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus I Infection; Drug Use	Drug: Bictegravir/emtricitabine/tenofovir alafenamide	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Nov 26, 2018
• Anticipated Primary Completion Date: Jun 30, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. Proportion of patients that achieved >90% adherence [Analysis will be done at 72 weeks]

   Proportion of patients that achieved >90% adherence

4. 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

5. 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

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

3. 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…

4. Participant is currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy)

5. Participant has a history or current indication of illicit drug use.

6. Patients infected with HCV and or HBV can be included in this study.

7. 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:

3. Creatinine Clearance Rate < 30 ml/min

4. Hemoglobin < 10.0 g/dL

5. Absolute neutrophil count <750 cells/mL

6. Platelet count < 50,000 /mL

7. ALT or AST >5x upper limit of normal (ULN)

8. Creatinine > 1.5x ULN

9. They are taking medication that is contraindicated with any component of B/F/TAF.

10. They are pregnant or breastfeeding.

11. They do not/have not ever used any form of illicit drug use.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vancouver Infectious Diseases Centre	Vancouver	British Columbia	Canada	V6Z 2C7
2	Victoria Cool Aid Society	Victoria	British Columbia	Canada	V8W 2G2

Sponsors and Collaborators

• Vancouver Infectious Diseases Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vancouver Infectious Diseases Centre
• ClinicalTrials.gov Identifier: NCT04132674
• Other Study ID Numbers: Biktarvy Study
• First Posted: Oct 21, 2019
• Last Update Posted: Oct 21, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide

Study Results

No Results Posted as of Oct 21, 2019