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

Shanghai Public Health Clinical Center3 sites in 1 country150 target enrollmentDecember 8, 2021

ConditionsHIV-1-infection

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

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

Overview

Phase: Phase 4
Intervention: B/F/TAF
Conditions: HIV-1-infection
Sponsor: Shanghai Public Health Clinical Center
Enrollment: 150
Locations: 3
Primary Endpoint: Percentage change from baseline in spine and hip bone mineral density (DXA) at 48 weeks
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

December 8, 2021

End Date

April 28, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Public Health Clinical Center

Responsible Party

Principal Investigator

Jun Chen, MD

Deputy Director of Department of Infectious Diseases and Immunology

Shanghai Public Health Clinical Center

Eligibility Criteria

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;

Arms & Interventions

B/F/TAF group

Bictegravir/emtricitabine/tenofovir alafenamide for 48 weeks.

Intervention: B/F/TAF

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.

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

Outcomes

Primary Outcomes

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

Time Frame: From baseline to Week 48

Secondary Outcomes

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 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)
Adherence (Visual Analog Scale) change from baseline 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)
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)
Patients reported outcome using SSC-HIV-SC scale(From baseline to Week 24, 48)
Percentage change from baseline in spine and hip bone mineral density (DXA) at Week 24(From baseline to Week 24)
Changes from Baseline in Spine and Hip Bone Mineral Density T-Values (DXA) at Weeks 24 and 48(From baseline to Week 24, 48)