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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: B/F/TAF; Drug: TDF-based triple ART regimen switching to B/F/TAF

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jun Chen, M.D; Phone Number: 3222 021-37990333; Email: qtchenjun@163.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B/F/TAF group; Bictegravir/emtricitabine/tenofovir alafenamide for 48 weeks.	Drug: B/F/TAF; Bictegravir/emtricitabine/tenofovir alafenamide once daily, 1 tablet at a time, with or without food for 48 weeks.
Active Comparator: TDF-based triple ART regimen switching to B/F/TAF; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Changes from baseline in CD4 T cell count at Weeks 24 and 48	From baseline to Week 24, 48
Changes from baseline in CD4/CD8 ratio at Weeks 24 and 48	From baseline to Week 24, 48
Changes from baseline in blood lipid (TC, TG, LDL, HDL) at Weeks 24 and 48	From baseline to Week 24, 48
Quality of life score (WHO QOL-BREF-HIV Scale) change from baseline at Weeks 24 and 48	From baseline to Week 24, 48
Adherence (Visual Analog Scale) change from baseline at Weeks 24 and 48	From baseline to Week 24, 48
Patients reported outcome using SSC-HIV-SC scale	From baseline to Week 24, 48

Collaborators and Investigators

• Sponsor: Shanghai Public Health Clinical Center
• Collaborators: Yunnan AIDS Care Center; Xixi Hospital of Hangzhou
• Investigators: Principal Investigator: Jun Chen, M.D, Shanghai Public Health Clinical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): April 28, 2024

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HIV-1 infection; Tenofovir Disoproxil Fumarate; Bictegravir/Emtricitabine/Tenofovir alafenamide
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; HIV Infections; Infections; Communicable Diseases
• Other Study ID Numbers: B/F/TAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes