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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B/F/TAF | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bictegravir/emtricitabine/tenofovir alafenamide | Drug | Taking one oral tablet of B/F/TAF once-daily for 72 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes of adherence | Changes of adherence from baseline at week 2, 8, 24, 48, and 72 with an adherence questionnaire |
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Inclusion Criteria:
Participant is ≥19 years of age infected with HIV-1
Participant has an undetectable viral load <40 copies/mL at screening with any CD4 count and has exhibited any, or all of the following:
Exclusion Criteria:
They have any documented history of integrase inhibitor resistance
They exhibit any of the following:
They are taking medication that is contraindicated with any component of B/F/TAF.
They are pregnant or breastfeeding.
They do not/have not ever used any form of illicit drug use.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rossitta Yung | Contact | 604-642-6429 | 303 | rossitta.yung@vidc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Infectious Diseases Centre | Recruiting | Vancouver | British Columbia | V6Z 2C7 | Canada |
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| Analysis will be done at 72 weeks |
| Proportion of patients that achieved >90% adherence | Proportion of patients that achieved >90% adherence | 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 viral blips on regimens pre-switch compared to the blips on B/F/TAF | 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 participants that discontinued B/F/TAF due to side-effects at weeks 36 and72 | 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 | 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 |
| Victoria Cool Aid Society | Recruiting | Victoria | British Columbia | V8W 2G2 | Canada |
|
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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