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.
This study is a multicenter, randomized, controlled, open labeled clinical trial, which aims to evaluate the safety and efficacy of B/F/TAF versus TDF-based antiretroviral therapy in HIV-infected individuals with virological suppression, and to evaluate the changes in quality of life and adherence after switching from a TDF-based regimen to B/F/TAF in HIV-infected individuals with virological suppression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Bictegravir/emtricitabine/tenofovir alafenamide once daily, 1 tablet at a time, with or without food for 48 weeks.
Tenofovir disoproxil fumarate was administered once daily, one tablet at a time, with or without food. After Week 24, control subjects were also switched to bictegravir/emtricitabine/tenofovir alafenamide once daily, one tablet at a time, with or without food for the later 24 weeks.
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Yunnan AIDS Care Center
Kunming, Yunnan, China
Xixi hospital of Hangzhou
Hangzhou, Zhejiang, China
Percentage change from baseline in spine and hip bone mineral density (DXA) at 48 weeks
Time frame: From baseline to Week 48
Percentage change from baseline in spine and hip bone mineral density (DXA) at Week 24
Time frame: From baseline to Week 24
The percentage of subjects with spine or hip bone mineral density (DXA) that increased or decreased by more than 3% (not included) from baseline at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Changes from Baseline in Spine and Hip Bone Mineral Density T-Values (DXA) at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Changes from Baseline in eGFR at Weeks 24 and 48 (CKD-EPI Formula)
Time frame: From baseline to Week 24, 48
The percentage of subjects with HIV viral load < 50 copies /ml at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Changes from baseline in CD4 T cell count at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Changes from baseline in CD4/CD8 ratio at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Changes from baseline in blood lipid (TC, TG, LDL, HDL) at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Quality of life score (WHO QOL-BREF-HIV Scale) change from baseline at Weeks 24 and 48
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Time frame: From baseline to Week 24, 48
Adherence (Visual Analog Scale) change from baseline at Weeks 24 and 48
Time frame: From baseline to Week 24, 48
Patients reported outcome using SSC-HIV-SC scale
Time frame: From baseline to Week 24, 48