Phase 3b RCTRecruiting

BFTAF Elderly
Switch Study

Switching virally suppressed HIV-1 infected elderly adults (age ≥ 60 years) without prior confirmed virological failure from current anti-retroviral regimen to bictegravir, emtricitabine and tenofovir alafenamide.

Duration

96 weeks

Participants

520 adults

Age criteria

≥ 60 years

Study Design

Multi-centre randomized control trial assessing the efficacy and safety of switching to B/F/TAF as compared to maintaining the current ARV regimen in 520 virologically suppressed HIV-1 positive elderly adults (≥ 60 years) with no prior confirmed virological failure.

Primary Endpoint

Proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 48

Study Objectives

Assess the efficacy of switching to B/F/TAF versus maintaining current ARV regimen in elderly adults

Evaluate the safety and tolerability of B/F/TAF in patients aged ≥60 years

Compare viral suppression rates between treatment arms at Week 48

Monitor changes in renal and bone biomarkers following treatment switch