HIV-1-infectionBIC-STaRNCT03580668
Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide
An observational study of HIV-1-infection, run by Gilead Sciences at 6 sites in Canada.
Trial summary
The primary objective of this study is to evaluate HIV-1 RNA suppression, defined as HIV-1 RNA <50 copies/mL, at 12 months after initiating or switching to Bictegravir/ Emtricitabine/Tenofovir alafenamide (B/F/TAF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- B/F/TAF
- How many people
- 201 participants
- Where
- 6 sitesCanada
- Study dates
- 13 Nov 2018to 3 Jun 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will be comprised of ART-naïve and ART-experienced HIV-1 infected adults aged ≥18 years initiating treatment with B/F/TAF in routine clinical care in Canada.
Who may be able to join
- HIV-1 infection
- Signed informed consent
- Initiating treatment with B/F/TAF in accordance with the product monograph
Who cannot join
- Participation in any other observational or interventional clinical trial without prior approval from the Medical Monitor
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Clinique Medicale du Quartier Latin
Montreal, H2L 4E9
University of Ottawa
Ottawa, K1N 6N5
Regina General Hospital
Regina, S4P 0W5
St. Clair Medical Association/Balmoral Clinic
Toronto, M4T3A7
Maple Leaf Research
Toronto, M5G 1K2
Spectrum Health
Vancouver, V6Z 2T1
About this study
Official title: Multi-center, Canadian, Non-interventional, Cohort Study of the Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adult Patients Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
The primary objective of this study is to evaluate HIV-1 RNA suppression, defined as HIV-1 RNA <50 copies/mL, at 12 months after initiating or switching to Bictegravir/ Emtricitabine/Tenofovir alafenamide (B/F/TAF).
- Conditions
- HIV-1-infection
- Being tested
- B/F/TAF
- Keywords
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/F/TAFDrug
Also called Biktarvy®
B/F/TAF administered in accordance with the approved product monograph
| Study group | Role | What they receive |
|---|---|---|
| B/F/TAF | Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF) therapy in HIV-1 infected adults who initiate B/F/TAF therapy Receives: Drug: B/F/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after initiating or switching to B/F/TAF
Measured: 12 months
Secondary outcomes (22)
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months after initiating or switching to B/F/TAF
Measured: 3 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 6 Months after initiating or switching to B/F/TAF
Measured: 6 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 24 Months after initiating or switching to B/F/TAF
Measured: 24 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 36 Months after initiating or switching to B/F/TAF
Measured: 36 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 48 Months after initiating or switching to B/F/TAF
Measured: 48 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 60 Months after initiating or switching to B/F/TAF
Measured: 60 months
Change in CD4 Cell Count at 3 Months
Measured: 3 months
Change in CD4 Cell Count at 6 Months
Measured: 6 months
Change in CD4 Cell Count at 12 Months
Measured: 12 months
Change in CD4 Cell Count at 24 Months
Measured: 24 months
Change in CD4 Cell Count at 36 Months
Measured: 36 months
Change in CD4 Cell Count at 48 Months
Measured: 48 months
Change in CD4 Cell Count at 60 Months
Measured: 60 months
CD4/CD8 Ratio at 3 Months
Measured: 3 months
CD4/CD8 Ratio at 6 Months
Measured: 6 months
CD4/CD8 Ratio at 12 Months
Measured: 12 months
CD4/CD8 Ratio at 24 Months
Measured: 24 months
CD4/CD8 Ratio at 36 Months
Measured: 36 months
CD4/CD8 Ratio at 48 Months
Measured: 48 months
CD4/CD8 Ratio at 60 Months
Measured: 60 months
Proportion of Participants Experiencing Adverse Events (AEs)
Measured: 60 months
Proportion of Participants Experiencing and Serious Adverse Events (SAEs)
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start13 Nov 2018
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580668
- Sponsor's protocol ID
- GS-CA-380-4574
- Acronym
- BIC-STaR
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2018
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antinori A, Yokomaku Y, Elinav H, Pullukcu H, de Wet J, Antela A, Lu PL, Sabranski M, Kim YS, Bonnet F, den Hollander J, Jackson A, Choy CY, Cai W, Zhang F, Thorpe D, Marongiu A, Harrison R, Jarrett J, Boffito M. Quality of Life and Treatment Satisfaction in People with HIV Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Pooled Analysis from Observational Cohort Studies. Infect Dis Ther. 2026 Jan;15(1):217-244. doi: 10.1007/s40121-025-01252-w. Epub 2025 Nov 24.
PubMed 41284214
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Canadian, Non-interventional, Cohort Study of the Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adult Patients Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
- ClinicalTrials.gov ID
- NCT03580668
- Acronym / sponsor ID
- BIC-STaR / GS-CA-380-4574
- Conditions
- HIV-1-infection
- Keywords
- Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 9 Jul 2018 (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.
The primary objective of this study is to evaluate HIV-1 RNA suppression, defined as HIV-1 RNA <50 copies/mL, at 12 months after initiating or switching to Bictegravir/ Emtricitabine/Tenofovir alafenamide (B/F/TAF).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B/F/TAF | – | Drug: B/F/TAFBictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF) therapy in HIV-1 infected adults who initiate B/F/TAF therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be comprised of ART-naïve and ART-experienced HIV-1 infected adults aged ≥18 years initiating treatment with B/F/TAF in routine clinical care in Canada.
Key inclusion criteria (3 listed)
- HIV-1 infection
- Signed informed consent
- Initiating treatment with B/F/TAF in accordance with the product monograph
Key exclusion criteria (1 listed)
- Participation in any other observational or interventional clinical trial without prior approval from the Medical Monitor
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 |
|---|---|---|
| B/F/TAFAlso: Biktarvy®B/F/TAF administered in accordance with the approved product monograph | Drug | B/F/TAF |
Primary outcome
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after initiating or switching to B/F/TAF
Time frame: 12 months
22 secondary outcomes
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months after initiating or switching to B/F/TAF
Time frame: 3 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 6 Months after initiating or switching to B/F/TAF
Time frame: 6 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 24 Months after initiating or switching to B/F/TAF
Time frame: 24 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 36 Months after initiating or switching to B/F/TAF
Time frame: 36 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 48 Months after initiating or switching to B/F/TAF
Time frame: 48 months
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 60 Months after initiating or switching to B/F/TAF
Time frame: 60 months
Change in CD4 Cell Count at 3 Months
Time frame: 3 months
Change in CD4 Cell Count at 6 Months
Time frame: 6 months
Change in CD4 Cell Count at 12 Months
Time frame: 12 months
Change in CD4 Cell Count at 24 Months
Time frame: 24 months
Change in CD4 Cell Count at 36 Months
Time frame: 36 months
Change in CD4 Cell Count at 48 Months
Time frame: 48 months
Change in CD4 Cell Count at 60 Months
Time frame: 60 months
CD4/CD8 Ratio at 3 Months
Time frame: 3 months
CD4/CD8 Ratio at 6 Months
Time frame: 6 months
CD4/CD8 Ratio at 12 Months
Time frame: 12 months
CD4/CD8 Ratio at 24 Months
Time frame: 24 months
CD4/CD8 Ratio at 36 Months
Time frame: 36 months
CD4/CD8 Ratio at 48 Months
Time frame: 48 months
CD4/CD8 Ratio at 60 Months
Time frame: 60 months
Proportion of Participants Experiencing Adverse Events (AEs)
Time frame: 60 months
Proportion of Participants Experiencing and Serious Adverse Events (SAEs)
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Derived from this study: PubMed 41284214Antinori A, Yokomaku Y, Elinav H, Pullukcu H, de Wet J, Antela A, Lu PL, Sabranski M, Kim YS, Bonnet F, den Hollander J, Jackson A, Choy CY, Cai W, Zhang F, Thorpe D, Marongiu A, Harrison R, Jarrett J, Boffito M. Quality of Life and Treatment Satisfaction in People with HIV Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Pooled Analysis from Observational Cohort Studies. Infect Dis Ther. 2026 Jan;15(1):217-244. doi: 10.1007/s40121-025-01252-w. Epub 2025 Nov 24.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Gilead Study Director study director
Gilead Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Gilead Sciences at 6 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after initiating or switching to B/F/TAF (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03580668, which also lists 1 linked publication.
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 18 Jun 2024.