Clinical trial NCT06104306: Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
Official title: A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-1-infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Experiencing Treatment Emergent Grade 3 or 4 Drug-related Adverse Events Through Week 12 (Co-Primary Endpoint)
timeFrame: First dose up to Week 12
measure: Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 12 (Co-Primary Endpoint)
timeFrame: First dose up to Week 12
Secondary outcomes:
measure: Plasma Concentrations of Bictegravir (BIC), Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1
timeFrame: Day 1
measure: Plasma Concentration of BIC, CAB, and RPV at Week 4
timeFrame: Week 4
measure: Plasma Concentration of BIC, CAB, and RPV at Week 12
timeFrame: Week 12
measure: Plasma Concentration of BIC, CAB, and RPV at Week 24
timeFrame: Week 24
measure: Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Missing = Excluded Approach
timeFrame: Week 12
measure: Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Missing = Excluded Approach
timeFrame: Week 24
measure: Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Discontinuation = Failure Approach
timeFrame: Week 12
measure: Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Discontinuation = Failure Approach
timeFrame: Week 24
measure: Percentage of Participants with Discontinuation of B/F/TAF by Week 12
timeFrame: Up to 12 Weeks
measure: Percentage of Participants with Discontinuation of B/F/TAF by Week 24
timeFrame: Up to 24 Weeks
measure: Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 24
timeFrame: First dose up to Week 24
measure: HIV Treatment Satisfaction Questionnaire Change (HIVTSQc) Total Score at Week 4
timeFrame: Week 4
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Franco Felizarta, MD
state: California
city: Palm Springs
country: United States
facility: BIOS Clinical Research
state: California
city: San Diego
country: United States
facility: UC San Diego AntiViral Research Center (AVRC)
state: California
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center
state: Florida
city: Orlando
country: United States
facility: Bliss Health
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Infectious Diseases Research
state: Indiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Las Vegas
country: United States
facility: Las Vegas Research Center
state: Nevada
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: Spokane
country: United States
facility: MultiCare Rockwood Main Clinic
state: Washington
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-SIS Clinic
city: Toronto
country: Canada
facility: St. Michael's Hospital
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital Saint-Andre
city: Marseille
country: France
facility: APHM - Hospital Sainte Marguerite
city: Orleans
country: France
facility: CHR Orleans
city: Pringy Cedex
country: France
facility: Centre Hospitalier Annecy Genevois
city: Strasbourg
country: France
facility: HU de Strasbourg - Nouvel Hopital Civil
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: