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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV-1-infection

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


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bictegravir/Emtricitabine/Tenofovir alafenamide, Tenofovir Disoproxil Fumarate, HIV-1 infection