Switching From TDF-based Antiretroviral Therapy Regimens to B/F/TAF in Virally Suppressed Adults With HIV-1 Infection
NCT ID: NCT05122754
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2021-12-08
2024-04-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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B/F/TAF group
Bictegravir/emtricitabine/tenofovir alafenamide for 48 weeks.
B/F/TAF
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/TAF
TDF-based triple ART regimen for 24 weeks, and all switch to bictegravir/emtricitabine/tenofovir alafenamide for the later 24 weeks.
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.
Interventions
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B/F/TAF
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/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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.).
18 Years
ALL
No
Sponsors
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Xixi Hospital of Hangzhou
UNKNOWN
Yunnan AIDS Care Center
OTHER
Shanghai Public Health Clinical Center
OTHER_GOV
Responsible Party
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Jun Chen, MD
Deputy Director of Department of Infectious Diseases and Immunology
Principal Investigators
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Jun Chen, M.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Public Health Clinical Center
Locations
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Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Yunnan AIDS Care Center
Kunming, Yunnan, China
Xixi hospital of Hangzhou
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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B/F/TAF
Identifier Type: -
Identifier Source: org_study_id