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

• Status: Not yet recruiting
• Trial end date: 2023-04-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Public Health Clinical Center
• Collaborators: Xixi Hospital of Hangzhou; Yunnan AIDS Care Center

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.).