Status:
COMPLETED
Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
Lead Sponsor:
Gilead Sciences
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this clinical study is to learn how safe and effective it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in part...
Eligibility Criteria
Inclusion
- Key
- People with HIV-1 (PWH) or provider decision to switch off CAB+RPV IM injections due to intolerance, inconvenience, adverse events (AEs), or willing to switch to (and intention to remain on) daily B/F/TAF
- Currently virologically suppressed (HIV-1 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 BIC, emtricitabine (FTC), or tenofovir (TFV).
- Key
Exclusion
- History of B/F/TAF intolerance
- History of previous 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.
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06104306
Start Date
December 13 2023
End Date
April 23 2025
Last Update
May 7 2025
Active Locations (18)
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1
Franco Felizarta, MD
Bakersfield, California, United States, 93301
2
BIOS Clinical Research
Palm Springs, California, United States, 92262
3
UC San Diego AntiViral Research Center (AVRC)
San Diego, California, United States, 92103
4
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982