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

  • days left to enroll
  • participants needed
  • sponsor
    Shanghai Public Health Clinical Center
Updated on 12 March 2022


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.


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.

Condition HIV-1-infection
Treatment B/F/TAF, TDF-based triple ART regimen switching to B/F/TAF
Clinical Study IdentifierNCT05122754
SponsorShanghai Public Health Clinical Center
Last Modified on12 March 2022


Yes No Not Sure

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.)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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