BFTAF Elderly Switch Study

RecruitingPhase 3b RCT

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 (B/F/TAF)

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 ≥60 years
  • Compare viral suppression rates between treatment arms at Week 48
  • Monitor changes in renal and bone biomarkers following treatment switch

Study Information

Duration96 weeks
Participants520 adults ≥60 years

Study Sites

Kenyatta National Hospital
Moi Teaching and Referral Hospital
Additional clinical sites