Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults

BETAF-RED

This is a phase IV, unicentric, open, pilot, randomized, controlled trial to evaluate Bictegravir/FTC/TAF. The study will be developed at a single clinical care centre:Hospital Clínic de Barcelona, Barcelona, Spain. The aim of this study is to assess the feasibility of dose redutions of Bictegravir/FTC/TAF in virologically suppressed HIV-infected adults on BETAF once daily. The reduction of drug exposure will have a significant positive impact on parameters reflecting potential toxicities associated with bictegravir or tenofovir.

2022-11-15

2024-11-15

2025-07-03

Active (not recruiting)

Early phase I

40

Inclusion Criteria: * Stable and asymptomatic HIV-infected adults (≥18 years) on BETAF once daily for at least the previous 6 months. * Plasma HIV-1 RNA less than 50 copies/mL for at least the previous 6 months. * CD4 cell counts greater than 350 cells/mL at the time of consideration for the study. * Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods. * Patients agreed to participate. Exclusion Criteria: * Prior virological failure to any antiretroviral regimen or documented. * Any diagnosis of psychiatric illness. * Alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment). * Patients co-infected with HIV and active hepatitis B or C virus. * Any other condition at the doctor's discretion that did not allow ensuring a correct adherence.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-09-21