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

NCT05122754 | Unknown Phase 4 FDA Drug

• 1 other identifier: B/F/TAF
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HIV-1-infection

Keywords

Bictegravir/Emtricitabine/Tenofovir alafenamide; Tenofovir Disoproxil Fumarate; HIV-1 infection

Outcome Measures

Primary Outcomes (1)

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

  From baseline to Week 48

Secondary Outcomes (11)

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

  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

  From baseline to Week 24, 48

• Changes from Baseline in Spine and Hip Bone Mineral Density T-Values (DXA) at Weeks 24 and 48

  From baseline to Week 24, 48

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

  From baseline to Week 24, 48

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

  From baseline to Week 24, 48

Study Arms (2)

B/F/TAF group

EXPERIMENTAL

Bictegravir/emtricitabine/tenofovir alafenamide for 48 weeks.

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.

Drug: TDF-based triple ART regimen switching to B/F/TAF

Interventions

B/F/TAF DRUG

Bictegravir/emtricitabine/tenofovir alafenamide once daily, 1 tablet at a time, with or without food for 48 weeks.

B/F/TAF group

TDF-based triple ART regimen switching to B/F/TAF DRUG

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.

TDF-based triple ART regimen switching to B/F/TAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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);
• 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.).

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead
• Xixi Hospital of Hangzhou: collaborator
• Yunnan AIDS Care Center: collaborator

Study Sites (3)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

Yunnan AIDS Care Center

Kunming, Yunnan, China

Location

Xixi hospital of Hangzhou

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 41266678 DERIVED

Study Officials

• Jun Chen, M.D

  Shanghai Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Department of Infectious Diseases and Immunology

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 17, 2021
• Study Start: December 8, 2021
• Primary Completion: February 28, 2024
• Study Completion: April 28, 2024
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)