Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

Gilead Sciences

Status and phase

Enrolling

Phase 4

Conditions

HIV-1-infection

Treatments

Drug: B/F/TAF

Study type

Interventional

Funder types

Industry

Identifiers

NCT06104306

GS-US-380-6738

2023-506660-13 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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).

Key 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.