Clinical trial
Switching From Tenofovir Disoproxil Fumarate-based Antiretroviral Therapy Regimens to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virally Suppressed Adults With HIV-1 Infection
Name
B/F/TAF
Description
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.
Trial arms
Trial start
2021-12-08
Estimated PCD
2024-02-28
Trial end
2024-04-28
Status
Active (not recruiting)
Phase
Early phase I
Treatment
B/F/TAF
Bictegravir/emtricitabine/tenofovir alafenamide once daily, 1 tablet at a time, with or without food for 48 weeks.
Arms:
B/F/TAF group
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.
Arms:
TDF-based triple ART regimen switching to B/F/TAF
Size
150
Primary endpoint
Percentage change from baseline in spine and hip bone mineral density (DXA) at 48 weeks
From baseline to Week 48
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;
* 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.).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-12-21
1 organization
2 products
1 indication
Organization
Shanghai Public Health Clinical CenterProduct
B/F/TAFIndication
HIV-1 infectionProduct
TDF-based triple ART regimen