Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
NCT ID: NCT06104306
Last Updated: 2026-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
33 participants
INTERVENTIONAL
2023-12-13
2025-04-23
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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B/F/TAF
Participants will receive a fixed dose combination of B/F/TAF 50/200/25 mg once daily for 24 weeks.
B/F/TAF
Tablets administered orally without regard to food
Interventions
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B/F/TAF
Tablets administered orally without regard to food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently virologically suppressed (HIV-1 ribonucleic acid (RNA) \< 50 copies/mL) on CAB+RPV IM injections every 2 months.
* Currently on CAB+RPV IM injections every 2 months and received at least one dose of CAB+RPV IM injection; no missed CAB+RPV injections.
* Ability to receive B/F/TAF up to 7 days prior to the next scheduled dose of CAB+RPV.
* Documented plasma HIV-1 RNA \< 50 copies/mL during treatment for ≥ 6 months preceding the screening visit.
* No documented or suspected resistance to bictegravir, emtricitabine, or tenofovir.
Exclusion Criteria
* History of previous integrase strand-transfer inhibitor (INSTI) virologic failure including CAB+RPV.
* Requirement for ongoing therapy with any prohibited medications listed in local prescribing information for B/F/TAF starting within 30 days prior to screening until 30 days following the last dose of study drug.
* Have been treated within 3 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic (at least 4 weeks) systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies)
* Need for oral antiretroviral therapy (ART) bridge or use of other antiretroviral (ARV) agents prior to starting B/F/TAF on Day 1
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Franco Felizarta, MD
Bakersfield, California, United States
BIOS Clinical Research
Palm Springs, California, United States
UC San Diego AntiViral Research Center (AVRC)
San Diego, California, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Bliss Health
Orlando, Florida, United States
Indiana University Infectious Diseases Research
Indianapolis, Indiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Las Vegas Research Center
Las Vegas, Nevada, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
MultiCare Rockwood Main Clinic
Spokane, Washington, United States
Hamilton Health Sciences-SIS Clinic
Hamilton, , Canada
St. Michael's Hospital
Toronto, , Canada
University Health Network - Toronto General Hospital
Toronto, , Canada
CHU Bordeaux - Hopital Saint-Andre
Bordeaux, , France
APHM - Hospital Sainte Marguerite
Marseille, , France
CHR Orleans
Orléans, , France
Centre Hospitalier Annecy Genevois
Pringy, , France
HU de Strasbourg - Nouvel Hopital Civil
Strasbourg, , France
Countries
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References
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Priyanka Arora, Moti Ramgopal, Thomas CS Martin, Hui Liu, Jason T Hindman, Jason Okulicz, Dhananjay D Marathe, Samir Gupta Pharmacokinetics and Safety Data After Switching From Injectable CAB + RPV to Oral B/F/TAF 20th European AIDS Conference (EACS); October 15-18, 2025
Samir Gupta, Thomas Martin, Cyril Gaultier, Alexandra Kissling, Kathleen Beusterien, Megan Chen, Megan Dunbar, Hui Liu, Brenda Ng, Moti Ramgopal Evaluation of Treatment Satisfaction and Experiences Among People With HIV When Switching to B/F/TAF From CAB + RPV: Results From the Phase 4 EMPOWER Study IDWeek; October 19-22, 2025; Atlanta, GA, USA
Sharon Walmsley, Moti Ramgopal, Thomas Martin, Jason T Hindman, Hui Liu, Keith Aizen, Jason Okulicz, Samir Gupta A Phase 4 Study to Evaluate the Safety and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV IDWeek; October 19-22, 2025; Atlanta, GA, USA
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2023-506660-13
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-380-6738
Identifier Type: -
Identifier Source: org_study_id
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