Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
NCT06104306 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2026-02-11
Summary
The goal of this clinical study is to learn how safe it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels.
The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12.
Conditions
Interventions
- DRUG
-
B/F/TAF
Tablets administered orally without regard to food
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-13
- Primary Completion
- 2025-01-29
- Completion
- 2025-04-23
- FDA Drug
- Yes
Countries
- United States
- Canada
- France
Study Locations
More Related Trials
-
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
-
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
NCT01968551 ·Status: COMPLETED ·Phase: PHASE3
-
Switch From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to E/C/F/TAF in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE)
NCT03493568 ·Status: TERMINATED ·Phase: PHASE3
-
Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR
NCT01286740 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
NCT01967940 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
NCT03405935 ·Status: COMPLETED ·Phase: PHASE3
-
Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
NCT01818596 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment
NCT01709084 ·Status: COMPLETED ·Phase: PHASE3
-
BFTAF Elderly Switch Study
NCT05243602 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF
NCT01252940 ·Status: COMPLETED ·Phase: PHASE3
-
Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations
NCT00011089 ·Status: UNKNOWN ·Phase: NA
-
Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'
NCT04653194 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants
NCT03631732 ·Status: COMPLETED ·Phase: PHASE3
-
D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
NCT01565850 ·Status: COMPLETED ·Phase: PHASE2
-
Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults
NCT04311957 ·Status: UNKNOWN ·Phase: PHASE4
-
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
NCT02269917 ·Status: COMPLETED ·Phase: PHASE3
-
Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
NCT04483674 ·Status: UNKNOWN ·Phase: PHASE2
-
Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection
NCT02733419 ·Status: COMPLETED ·Phase: PHASE3
-
The Benefits of Immediate Treatment Initiation Without Immunovirological Data Compared to Conventional BIC / FTC / TAF Treatment in Naive Patients With Type 1 HIV (Human Immunodeficiency Virus) Infection
NCT05606055 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects
NCT00529243 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics of Calcineurin & mTOR Inhibitors in HIV-1 Infected Kidney Transplant Recipients After Switch to BIC/FTC/TAF
NCT04993872 ·Status: UNKNOWN ·Phase: PHASE4
-
Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
NCT04296695 ·Status: UNKNOWN ·Phase: PHASE4
-
The Women TAF-FTC Benchmark Study
NCT05140954 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen
NCT02285114 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
NCT06101329 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2