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

NCT05122754 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-12-21

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Xixi Hospital of Hangzhou

    collaborator UNKNOWN

  • Yunnan AIDS Care Center

    collaborator OTHER

  • Shanghai Public Health Clinical Center

    lead OTHER_GOV

Principal Investigators

  • Jun Chen, M.D · Shanghai Public Health Clinical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-08
Primary Completion
2024-02-28
Completion
2024-04-28
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05122754 on ClinicalTrials.gov