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Switching to B/F/TAF in Elderly HIV-1 Patients
NCT03405935Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2018
- Primary completion
- Nov 2018
- Countries
- 5
- Sponsor
- Gilead Sciences
- Modality
- Small Molecules
- Conditions
- human immunodeficiency virus type 1 infection (HIV-1)
01
Overview
Phase 3, open-label, single-arm trial of bictegravir + emtricitabine + tenofovir alafenamide in human immunodeficiency virus type 1 infection (HIV-1), sponsored by Gilead Sciences. Primary endpoint: Percentage of Participants With HIV-1 RNA < 50 Copies/mL (Snapshot Algorithm) at 24 weeks. Started Mar 2018; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
B/F/TAF
Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC
03
Who it enrols
Virologically suppressed HIV-1 infected adults aged >= 65 years on a stable regimen of E/C/F/TAF or a TDF-containing regimen for at least 3 months.
04
Endpoints
Primary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL (Snapshot Algorithm)
Secondary
Percentage of Participants Experiencing Adverse Events
Percentage of Participants With HIV-1 RNA < 50 Copies/mL (Snapshot Algorithm)
Change From Baseline in CD4 Cell Count
Change From Baseline in CD4 Percentage
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