Human Immunodeficiency Virus I Infection, Drug Use
Conditions
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.
Interventions
Taking one oral tablet of B/F/TAF once-daily for 72 weeks
Sponsors
Vancouver Infectious Diseases Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Canada
Contacts
Primary ContactRossitta Yung
Outcome results
None listed