HIV-1-infectionPhase 4NCT05122754

Switching From TDF-based Antiretroviral Therapy Regimens to B/F/TAF in Virally Suppressed Adults With HIV-1 Infection

A Phase 4 study testing B/F/TAF and TDF-based triple ART regimen switching to B/F/TAF in people with HIV-1-infection, run by Shanghai Public Health Clinical Center at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To evaluate the safety and efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus tenofovir disoproxil fumarate-based antiretroviral regimens in HIV-infected individuals with virological suppression. 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 and TDF-based triple ART regimen switching to B/F/TAF
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 3 sitesChina
Study dates: 8 Dec 2021to 28 Apr 2024
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meet the Diagnostic Criteria for AIDS or HIV Infection (WS 293-2019);
Age 18 or above (included 18);
Continuous administration of a TDF-based triple ART regimen with a backbone of non-nucleoside reverse transcriptase or protease inhibitors ≥24 weeks and ongoing use;
Maintaining virological suppression (viral load < 50 copies/mL) for ≥ 24 weeks, and maintaining virological suppression at present;
Glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 (calculated according to the CKD-EPI formula);
ECG is normal;

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White blood cell count ≥3×109/L, Neutrophil count ≥1.5×109/L, Hemoglobin ≥90 g/L, and Platelet count ≥ 75×109/L;
Alanine aminotransferase and aspartate aminotransferase ≤5×ULN, direct bilirubin ≤1.5×ULN, amylase≤2×ULN；
Those who volunteered for this study and were able to complete all follow-up visits and sign the informed consent form in accordance with the protocol.

Who cannot join

In the 30 days(inclusive) before the screening period, an AIDS-related opportunistic infection or tumor occurred;
History of known past HIV resistance (confirmed HIV viral load > 200 copies /ml) or resistance to any nucleoside (acid) analogues;
Decompensated liver cirrhosis;
Female subject who has a positive urine pregnancy test;
Lactating women;
Women who are unable to take a reasonable method of contraception during the trial (including the Screening Period and 30 days after discontinuation of experimental drugs);

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Subjects had other medical conditions requiring treatment with either of the current ART regimens or other drugs which have drug-drug interaction with B/F/TAF and cannot be discontinued.
Being involved in other interventional clinical studies;
Those with allergic constitution or known allergy to the components of the drug;
Suffering from serious mental or neurological diseases;
Suspected or confirmed history of alcohol and drug abuse; Patients who were not considered by the investigator to be suitable for participating in this clinical trial (such as weak constitution, poor compliance, etc.).

Trial locations and contacts

3 sites in 1 country.

China3 sites

Xixi hospital of Hangzhou
Hangzhou, Zhejiang
Yunnan AIDS Care Center
Kunming, Yunnan
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508

Other trials in China

About this study

Official title: Switching From Tenofovir Disoproxil Fumarate-based Antiretroviral Therapy Regimens to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virally Suppressed Adults With HIV-1 Infection

Read the detailed description

This study is a multicenter, randomized, controlled, open labeled clinical trial, which aims to evaluate the safety and efficacy of B/F/TAF versus TDF-based antiretroviral therapy in HIV-infected individuals with virological suppression, and to evaluate the changes in quality of life and adherence after switching from a TDF-based regimen to B/F/TAF in HIV-infected individuals with virological suppression.

Conditions: HIV-1-infection
Being tested: B/F/TAF, TDF-based triple ART regimen switching to B/F/TAF
Keywords: Bictegravir/Emtricitabine/Tenofovir alafenamide, Tenofovir Disoproxil Fumarate, HIV-1 infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

B/F/TAFDrug
Bictegravir/emtricitabine/tenofovir alafenamide once daily, 1 tablet at a time, with or without food for 48 weeks.
TDF-based triple ART regimen switching to B/F/TAFDrug
Tenofovir disoproxil fumarate was administered once daily, one tablet at a time, with or without food. After Week 24, control subjects were also switched to bictegravir/emtricitabine/tenofovir alafenamide once daily, one tablet at a time, with or without food for the later 24 weeks.

Study groups in NCT05122754
Study group	Role	What they receive
B/F/TAF group	Experimental	Bictegravir/emtricitabine/tenofovir alafenamide for 48 weeks. Receives: Drug: B/F/TAF
TDF-based triple ART regimen switching to B/F/TAF	Active comparator	TDF-based triple ART regimen for 24 weeks, and all switch to bictegravir/emtricitabine/tenofovir alafenamide for the later 24 weeks. Receives: Drug: TDF-based triple ART regimen switching to B/F/TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage change from baseline in spine and hip bone mineral density (DXA) at 48 weeks
Measured: From baseline to Week 48

Secondary outcomes (11)

Percentage change from baseline in spine and hip bone mineral density (DXA) at Week 24
Measured: From baseline to Week 24
The percentage of subjects with spine or hip bone mineral density (DXA) that increased or decreased by more than 3% (not included) from baseline at Weeks 24 and 48
Measured: From baseline to Week 24, 48
Changes from Baseline in Spine and Hip Bone Mineral Density T-Values (DXA) at Weeks 24 and 48
Measured: From baseline to Week 24, 48
Changes from Baseline in eGFR at Weeks 24 and 48 (CKD-EPI Formula)
Measured: From baseline to Week 24, 48
The percentage of subjects with HIV viral load < 50 copies /ml at Weeks 24 and 48
Measured: From baseline to Week 24, 48
Changes from baseline in CD4 T cell count at Weeks 24 and 48
Measured: From baseline to Week 24, 48
Changes from baseline in CD4/CD8 ratio at Weeks 24 and 48
Measured: From baseline to Week 24, 48
Changes from baseline in blood lipid (TC, TG, LDL, HDL) at Weeks 24 and 48
Measured: From baseline to Week 24, 48
Quality of life score (WHO QOL-BREF-HIV Scale) change from baseline at Weeks 24 and 48
Measured: From baseline to Week 24, 48
Adherence (Visual Analog Scale) change from baseline at Weeks 24 and 48
Measured: From baseline to Week 24, 48
Patients reported outcome using SSC-HIV-SC scale
Measured: From baseline to Week 24, 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Dec 202128 Apr 2024

First posted17 Nov 2021
Study start8 Dec 2021
Primary completion28 Feb 2024 (estimated)
Study completion28 Apr 2024 (estimated)

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.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05122754
Sponsor's protocol ID: B/F/TAF
Status last verified: Dec 2023
First submitted: 21 Oct 2021
Last updated: 21 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Shao Y, Yang X, Yu J, Wang X, Wang J, Liu M, Yang Z, Han J, Zhang R, Liu L, Shen Y, Sun M, Wu L, Zheng Z, Tang Y, Yang J, Wang Z, Qi T, Xu S, Xun J, Sun J, Song W, Chen J. Bone Mineral Density Changes in People with HIV Who had Immediate Switch Versus Deferred Switch from Tenofovir Disoproxil Fumarate-Based Regimens to Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Multicenter, Open-Label, Randomized Clinical Trial. Infect Dis Ther. 2026 Jan;15(1):165-181. doi: 10.1007/s40121-025-01262-8. Epub 2025 Nov 21.
PubMed 41266678

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
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RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
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Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
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All HIV-1-infection trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Switching From Tenofovir Disoproxil Fumarate-based Antiretroviral Therapy Regimens to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virally Suppressed Adults With HIV-1 Infection
ClinicalTrials.gov ID: NCT05122754
Acronym / sponsor ID: B/F/TAF
Conditions: HIV-1-infection
Keywords: Bictegravir/Emtricitabine/Tenofovir alafenamide, Tenofovir Disoproxil Fumarate, HIV-1 infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: Shanghai Public Health Clinical CenterOther government
Collaborators: Xixi Hospital of Hangzhou, Yunnan AIDS Care Center
Study start: 8 Dec 2021 (actual)
Primary completion: 28 Feb 2024 (estimated)
Study completion: 28 Apr 2024 (estimated)
First posted: 17 Nov 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
B/F/TAF group	Experimental	Drug: B/F/TAFBictegravir/emtricitabine/tenofovir alafenamide for 48 weeks.
TDF-based triple ART regimen switching to B/F/TAF	Active comparator	Drug: TDF-based triple ART regimen switching to B/F/TAFTDF-based triple ART regimen for 24 weeks, and all switch to bictegravir/emtricitabine/tenofovir alafenamide for the later 24 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Meet the Diagnostic Criteria for AIDS or HIV Infection (WS 293-2019);
Age 18 or above (included 18);
Continuous administration of a TDF-based triple ART regimen with a backbone of non-nucleoside reverse transcriptase or protease inhibitors ≥24 weeks and ongoing use;
Maintaining virological suppression (viral load < 50 copies/mL) for ≥ 24 weeks, and maintaining virological suppression at present;
Glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 (calculated according to the CKD-EPI formula);

Key exclusion criteria (11 listed)

In the 30 days(inclusive) before the screening period, an AIDS-related opportunistic infection or tumor occurred;
History of known past HIV resistance (confirmed HIV viral load > 200 copies /ml) or resistance to any nucleoside (acid) analogues;
Decompensated liver cirrhosis;
Female subject who has a positive urine pregnancy test;
Lactating women;

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/TAFBictegravir/emtricitabine/tenofovir alafenamide once daily, 1 tablet at a time, with or without food for 48 weeks.	Drug	B/F/TAF group
TDF-based triple ART regimen switching to B/F/TAFTenofovir disoproxil fumarate was administered once daily, one tablet at a time, with or without food. After Week 24, control subjects were also switched to bictegravir/emtricitabine/tenofovir alafenamide once daily, one tablet at a time, with or without food for the later 24 weeks.	Drug	TDF-based triple ART regimen switching to B/F/TAF

Primary outcome

Percentage change from baseline in spine and hip bone mineral density (DXA) at 48 weeks
Time frame: From baseline to Week 48

11 secondary outcomes

Percentage change from baseline in spine and hip bone mineral density (DXA) at Week 24
Time frame: From baseline to Week 24
The percentage of subjects with spine or hip bone mineral density (DXA) that increased or decreased by more than 3% (not included) from baseline at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Changes from Baseline in Spine and Hip Bone Mineral Density T-Values (DXA) at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Changes from Baseline in eGFR at Weeks 24 and 48 (CKD-EPI Formula)
Time frame: From baseline to Week 24, 48
The percentage of subjects with HIV viral load < 50 copies /ml at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Changes from baseline in CD4 T cell count at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Changes from baseline in CD4/CD8 ratio at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Changes from baseline in blood lipid (TC, TG, LDL, HDL) at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Quality of life score (WHO QOL-BREF-HIV Scale) change from baseline at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Adherence (Visual Analog Scale) change from baseline at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Patients reported outcome using SSC-HIV-SC scale
Time frame: From baseline to Week 24, 48

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
Derived from this study: PubMed 41266678Shao Y, Yang X, Yu J, Wang X, Wang J, Liu M, Yang Z, Han J, Zhang R, Liu L, Shen Y, Sun M, Wu L, Zheng Z, Tang Y, Yang J, Wang Z, Qi T, Xu S, Xun J, Sun J, Song W, Chen J. Bone Mineral Density Changes in People with HIV Who had Immediate Switch Versus Deferred Switch from Tenofovir Disoproxil Fumarate-Based Regimens to Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Multicenter, Open-Label, Randomized Clinical Trial. Infect Dis Ther. 2026 Jan;15(1):165-181. doi: 10.1007/s40121-025-01262-8. Epub 2025 Nov 21.
Individual participant dataSharing planned: No

Related trials for HIV-1-infection

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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.

Jun Chen, M.D principal investigator

Shanghai Public Health Clinical Center

3 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 B/F/TAF and TDF-based triple ART regimen switching to B/F/TAF in people with HIV-1-infection, run by Shanghai Public Health Clinical Center at 3 sites in China.

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 9 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 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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?

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?

Percentage change from baseline in spine and hip bone mineral density (DXA) at 48 weeks (time frame: From baseline to Week 48). 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 NCT05122754, 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 21 Dec 2023.