LAST UPDATED
February 11, 2026
Clinicaltrials.gov ID
CTSID
OVERVIEW
A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV-1-infection
Gender
N/A
Date
December 2023 - January 2025
Study Type
Interventional
Study Phase
Phase 4
Product
B/F/TAF
Eligibility information
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Locations
Locations (18)
BIOS Clinical Research
Palm Springs, California, United States, 92262
UC San Diego AntiViral Research Center (AVRC)
San Diego, California, United States, 92103
Midway Immunology and Research Center
Ft. Pierce, Florida, United States, 34982
Indiana University Infectious Diseases Research
Indianapolis, Indiana, United States, 46202
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
MultiCare Rockwood Main Clinic
Spokane, Washington, United States, 99202
University Health Network - Toronto General Hospital
Toronto, Canada, M5G 2C4
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