HIV-1-infectionPhase 4NCT06104306
Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
A Phase 4 study testing B/F/TAF in people with HIV-1-infection, run by Gilead Sciences at 18 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- B/F/TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 13 Dec 2023to 23 Apr 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with human immunodeficiency virus type 1 (HIV-1) (PWH) or provider decision to switch off cabotegravir + rilpivirine (CAB+RPV) intramuscular (IM) injections due to intolerance, inconvenience, adverse events (AEs), or willing to switch to (and intention to remain on) daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF).
- 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.
Who cannot join
- History of B/F/TAF intolerance.
- 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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States10 sites
Franco Felizarta, MD
Bakersfield, California, 93301
Boston Medical Center
Boston, Massachusetts, 02118
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
Indiana University Infectious Diseases Research
Indianapolis, Indiana, 46202
Las Vegas Research Center
Las Vegas, Nevada, 89106
Saint Michael's Medical Center
Newark, New Jersey, 07102
Bliss Health
Orlando, Florida, 32806
BIOS Clinical Research
Palm Springs, California, 92262
UC San Diego AntiViral Research Center (AVRC)
San Diego, California, 92103
MultiCare Rockwood Main Clinic
Spokane, Washington, 99202
France5 sites
CHU Bordeaux - Hopital Saint-Andre
Bordeaux, 33075
APHM - Hospital Sainte Marguerite
Marseille
CHR Orleans
Orléans, 45100
Centre Hospitalier Annecy Genevois
Pringy, 74374
HU de Strasbourg - Nouvel Hopital Civil
Strasbourg
Canada3 sites
Hamilton Health Sciences-SIS Clinic
Hamilton, L8L2X2
St. Michael's Hospital
Toronto, M5B 1W8
University Health Network - Toronto General Hospital
Toronto, M5G 2C4
About this study
Official title: A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV
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
- HIV-1-infection
- Being tested
- B/F/TAF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/F/TAFDrug
Also called Biktarvy ®
Tablets administered orally without regard to food
| Study group | Role | What they receive |
|---|---|---|
| B/F/TAF | Experimental | Participants will receive a fixed dose combination of B/F/TAF 50/200/25 mg once daily for 24 weeks. Receives: Drug: B/F/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Treatment Emergent Grade 3 or 4 Drug-related Adverse Events Through Week 12 (Co-Primary Endpoint)
Treatment emergent adverse events (TEAEs) were defined as any AE that began on or after the date of first dose of study drug up to the date of last dose of study drug plus 30 days or any AE leading to study drug discontinuation. The severity of AEs were be graded using the Division of AIDS (DAIDS) Toxicity Grading Scale.
The DAIDS grading table provide an adverse events (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines:
- Grade 1 indicates a mild event
- Grade 2 indicates a moderate event
- Grade 3 indicates a severe event
- Grade 4 indicates a potentially life-threatening event
- Grade 5 indicates death
Measured: Week 12
Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 12 (Co-Primary Endpoint)
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time after baseline up to and including the date of last dose of study drug plus 30 days.
The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening.
Measured: Week 12
Secondary outcomes (12)
Plasma Concentrations of Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1 (Predose)
Measured: Day 1 (Predose)
Plasma Concentration of Bictegravir (BIC), CAB, and RPV at Week 4
Measured: Week 4 (at trough and 2 hours postdose)
Plasma Concentration of BIC, CAB, and RPV at Week 12
Measured: Week 12 (at trough and 2 hours postdose)
Plasma Concentration of BIC, CAB, and RPV at Week 24
Measured: Week 24 (at trough and 2 hours postdose)
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Missing = Excluded Approach
This outcome measure analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data were excluded in the analysis.
Measured: Week 12
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Missing = Excluded Approach
This outcome measure analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data were excluded in the analysis.
Measured: Week 24
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Discontinuation = Failure Approach
This outcome measure was analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation were treated as HIV-1 RNA >= 50 copies/mL (failure) in the analysis.
Measured: Week 12
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Discontinuation = Failure Approach
This outcome measure was analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation were treated as HIV-1 RNA >= 50 copies/mL (failure) in the analysis.
Measured: Week 24
Percentage of Participants With Discontinuation of B/F/TAF by Week 12
Measured: Up to 12 Weeks
Percentage of Participants With Discontinuation of B/F/TAF by Week 24
Measured: Up to 24 Weeks
Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 24
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time after baseline up to and including the date of last dose of study drug plus 30 days.
The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening.
Measured: Week 24
HIV Treatment Satisfaction (HIVTSQc) Score at Week 4
The HIVTSQc was a 1-12 items questionnaire. Each item was scored -3 to 3. The total score ranged from -33 to +33, based on 11 items. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start13 Dec 2023
- Primary completion29 Jan 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104306
- Sponsor's protocol ID
- GS-US-380-6738
- Other IDs
- 2023-506660-13, 2023
- Status last verified
- Jan 2026
- First submitted
- 23 Oct 2023
- Last updated
- 11 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
Publications
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