AzTrials
AzTrials

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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;
Show all 9Show fewer
  • 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);
Show all 11Show fewer
  • 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

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 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 groupRoleWhat they receive
B/F/TAF groupExperimentalBictegravir/emtricitabine/tenofovir alafenamide for 48 weeks.
Receives: Drug: B/F/TAF
TDF-based triple ART regimen switching to B/F/TAFActive comparatorTDF-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.

  1. Percentage change from baseline in spine and hip bone mineral density (DXA) at 48 weeks

    Measured: From baseline to Week 48

Secondary outcomes (11)

  1. Percentage change from baseline in spine and hip bone mineral density (DXA) at Week 24

    Measured: From baseline to Week 24

  2. 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

  3. 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

  4. Changes from Baseline in eGFR at Weeks 24 and 48 (CKD-EPI Formula)

    Measured: From baseline to Week 24, 48

  5. The percentage of subjects with HIV viral load < 50 copies /ml at Weeks 24 and 48

    Measured: From baseline to Week 24, 48

  6. Changes from baseline in CD4 T cell count at Weeks 24 and 48

    Measured: From baseline to Week 24, 48

  7. Changes from baseline in CD4/CD8 ratio at Weeks 24 and 48

    Measured: From baseline to Week 24, 48

  8. Changes from baseline in blood lipid (TC, TG, LDL, HDL) at Weeks 24 and 48

    Measured: From baseline to Week 24, 48

  9. Quality of life score (WHO QOL-BREF-HIV Scale) change from baseline at Weeks 24 and 48

    Measured: From baseline to Week 24, 48

  10. Adherence (Visual Analog Scale) change from baseline at Weeks 24 and 48

    Measured: From baseline to Week 24, 48

  11. 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.

  1. First posted17 Nov 2021
  2. Study start8 Dec 2021
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion28 Apr 2024 (estimated)

Resources

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

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in