Human Immunodeficiency Virus I InfectionPhase 4NCT04132674
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed
A Phase 4 study testing Bictegravir/emtricitabine/tenofovir alafenamide in people with Human Immunodeficiency Virus I Infection and Drug Use, run by Vancouver Infectious Diseases Centre at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Human Immunodeficiency Virus I Infection, Drug Use
- What is being tested?
- Bictegravir/emtricitabine/tenofovir alafenamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 26 Nov 2018to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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…
- Participant is currently on multi-tablet HIV antiretroviral therapy, including multi-tablet regimens and/or two drug combinations (dual therapy)
- Participant has a history or current indication of illicit drug use.
- Patients infected with HCV and or HBV can be included in this study.
- 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.
Who cannot join
- They have any documented history of integrase inhibitor resistance
- They exhibit any of the following:
- Creatinine Clearance Rate < 30 ml/min
- Hemoglobin < 10.0 g/dL
- Absolute neutrophil count <750 cells/mL
- Platelet count < 50,000 /mL
Show all 11Show fewer
- ALT or AST >5x upper limit of normal (ULN)
- Creatinine > 1.5x ULN
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Vancouver Infectious Diseases Centre
Vancouver, British Columbia, V6Z 2C7
Rossitta Yung, 604-642-6429 ext. 303, rossitta.yung@vidc.ca
Brian Conway, MD
- Recruiting
Victoria Cool Aid Society
Victoria, British Columbia, V8W 2G2
Marion Selfridge, 250-385-1466, marions@uvic.ca
Christopher Fraser, MD
About this study
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.
- Conditions
- Human Immunodeficiency Virus I Infection, Drug Use
- Being tested
- Bictegravir/emtricitabine/tenofovir alafenamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bictegravir/emtricitabine/tenofovir alafenamideDrug
Taking one oral tablet of B/F/TAF once-daily for 72 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Bictegravir/emtricitabine/tenofovir alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects that remain virally suppressed at week 48
The proportion of subjects with HIV RNA <40 copies/mL
Measured: Interim analysis of efficacy will be done at 24 weeks
Secondary outcomes (6)
The proportion of subjects with viral blips
Viral blips defined as detectable HIV viral load between 40-1000 copies/mL at week 72
Measured: 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
Measured: Analysis will be done at 72 weeks
Proportion of patients that achieved >90% adherence
Proportion of patients that achieved >90% adherence
Measured: 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
Measured: 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
Measured: 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
Measured: Analysis will be done at 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start26 Nov 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus I InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver Infectious Diseases Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132674
- Sponsor's protocol ID
- Biktarvy Study
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04132674
- Acronym / sponsor ID
- Biktarvy Study
- Conditions
- Human Immunodeficiency Virus I Infection, Drug Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vancouver Infectious Diseases CentreUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B/F/TAF | Other | Drug: Bictegravir/emtricitabine/tenofovir alafenamideSwitching 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bictegravir/emtricitabine/tenofovir alafenamideTaking one oral tablet of B/F/TAF once-daily for 72 weeks | Drug | B/F/TAF |
Primary outcome
The proportion of subjects that remain virally suppressed at week 48
Time frame: Interim analysis of efficacy will be done at 24 weeks
The proportion of subjects with HIV RNA <40 copies/mL
6 secondary outcomes
The proportion of subjects with viral blips
Time frame: Analysis will be done at 72 weeks
Changes of adherence
Time frame: Analysis will be done at 72 weeks
Proportion of patients that achieved >90% adherence
Time frame: Analysis will be done at 72 weeks
The proportion of viral blips on regimens pre-switch compared to the blips on B/F/TAF
Time frame: Analysis will be done at 72 weeks
The proportion of participants that discontinued B/F/TAF due to side-effects at weeks 36 and72
Time frame: 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
Time frame: Analysis will be done at 72 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bictegravir/emtricitabine/tenofovir alafenamide in people with Human Immunodeficiency Virus I Infection and Drug Use, run by Vancouver Infectious Diseases Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rossitta Yung (604-642-6429 ext. 303, rossitta.yung@vidc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects that remain virally suppressed at week 48 (time frame: Interim analysis of efficacy will be done at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.