Study Details

PROTOCOL 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 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.

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

HIV-1-infection

Gender

N/A

Date

December 2023 - November 2024

Study Type

Interventional

Study Phase

Phase 4

Product

B/F/TAF

Eligibility Information

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.

Locations

Locations (16)

Franco Felizarta, MD

Bakersfield, California, United States, 93301

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

Fort Pierce, Florida, United States, 34982

Bliss Health

Orlando, Florida, United States, 32806

Indiana University Infectious Diseases Research

Indianapolis, Indiana, United States, 46202

Boston Medical Center

Boston, Massachusetts, United States, 02118

Las Vegas Research Center

Las Vegas, Nevada, United States, 89106

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

CHU Bordeaux - Hopital Saint-Andre

Bordeaux, France, 33075

APHM - Hospital Sainte Marguerite

Marseille, France

CHR Orleans

Orleans, France, 45100

Centre Hospitalier Annecy Genevois

Pringy Cedex, France, 74374

HU de Strasbourg - Nouvel Hopital Civil

Strasbourg, France

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

OVERVIEW