for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
completion around



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 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.

Official Title

A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV


HIV-1-infection, Infections, B/F/TAF


You can join if…

Open to people ages 18 years and up

  • 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).

You CAN'T join if...

  • 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.


  • UC San Diego AntiViral Research Center (AVRC) accepting new patients
    San Diego California 92103 United States
  • Las Vegas Research Center accepting new patients
    Las Vegas Nevada 89106 United States


accepting new patients
Start Date
Completion Date
Gilead Sciences
Gilead Clinical Trials Website
Phase 4 HIV/AIDS Research Study
Study Type
Expecting 35 study participants
Last Updated