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

Shanghai Public Health Clinical Center

Status and phase: Active, not recruiting; Phase 4

Conditions: HIV-1-infection

Treatments: Drug: B/F/TAF; Drug: TDF-based triple ART regimen switching to B/F/TAF

Study type: Interventional

Funder types: Other

Identifiers

NCT05122754

B/F/TAF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

B/F/TAF group

Experimental group

Description:

Bictegravir/emtricitabine/tenofovir alafenamide for 48 weeks.

Treatment:

Drug: B/F/TAF

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

Active Comparator group

Description:

TDF-based triple ART regimen for 24 weeks, and all switch to bictegravir/emtricitabine/tenofovir alafenamide for the later 24 weeks.

Treatment:

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