NCT05122754

Switching From TDF-based Antiretroviral Therapy Regimens to B/F/TAF in Virally Suppressed Adults With HIV-1 Infection

Switching From Tenofovir Disoproxil Fumarate-based Antiretroviral Therapy Regimens to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virally Suppressed Adults With HIV-1 Infection

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shanghai Public Health Clinical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	B/F/TAF	Bictegravir/emtricitabine/tenofovir alafenamide once daily, 1 tablet at a time, with or without food for 48 weeks.
DRUG	TDF-based triple ART regimen switching to B/F/TAF	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.

Timeline

• Start date: 2021-12-08
• Primary completion: 2024-02-28
• Completion: 2024-04-28
• First posted: 2021-11-17
• Last updated: 2023-12-21

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated drug study