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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
B/F/TAF 		Participants will receive a fixed dose combination of B/F/TAF 50/200/25 mg once daily for 24 weeks
  • Drug: B/F/TAF
    Tablets administered without regard to food
    Other names:
    • Biktarvy ®

More Details

Status
Active, not recruiting
Sponsor
Gilead Sciences

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.