Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
- Conditions
- HIV-1-infection
- Interventions
- Drug: B/F/TAF
- Registration Number
- NCT06104306
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description B/F/TAF B/F/TAF Participants will receive a fixed dose combination of B/F/TAF 50/200/25 mg once daily for 24 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 12 (Co-Primary Endpoint) First dose up to Week 12 Percentage of Participants Experiencing Treatment Emergent Grade 3 or 4 Drug-related Adverse Events Through Week 12 (Co-Primary Endpoint) First dose up to Week 12
- Secondary Outcome Measures
Name Time Method Plasma Concentrations of Bictegravir (BIC), Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1 Day 1 Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Discontinuation = Failure Approach Week 24 This outcome measure will be analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation will be treated as HIV-1 RNA \>= 50 copies/mL (failure) in the analysis.
Percentage of Participants with Discontinuation of B/F/TAF by Week 24 Up to 24 Weeks Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Missing = Excluded Approach Week 12 This outcome measure will be analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data will be excluded in the analysis.
Plasma Concentration of BIC, CAB, and RPV at Week 4 Week 4 Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Missing = Excluded Approach Week 24 This outcome measure will be analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data will be excluded in the analysis.
Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Discontinuation = Failure Approach Week 12 This outcome measure will be analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation will be treated as HIV-1 RNA \>= 50 copies/mL (failure) in the analysis.
Percentage of Participants with Discontinuation of B/F/TAF by Week 12 Up to 12 Weeks Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 24 First dose up to Week 24 HIV Treatment Satisfaction Questionnaire Change (HIVTSQc) Total Score at Week 4 Week 4 The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. The total score may range from -33 to +33, based on 11 items. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 will represent no change.
Plasma Concentration of BIC, CAB, and RPV at Week 12 Week 12 Plasma Concentration of BIC, CAB, and RPV at Week 24 Week 24
Trial Locations
- Locations (18)
Franco Felizarta, MD
🇺🇸Bakersfield, California, United States
BIOS Clinical Research
🇺🇸Palm Springs, California, United States
UC San Diego AntiViral Research Center (AVRC)
🇺🇸San Diego, California, United States
Midway Immunology and Research Center
🇺🇸Fort Pierce, Florida, United States
Bliss Health
🇺🇸Orlando, Florida, United States
Indiana University Infectious Diseases Research
🇺🇸Indianapolis, Indiana, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Las Vegas Research Center
🇺🇸Las Vegas, Nevada, United States
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
MultiCare Rockwood Main Clinic
🇺🇸Spokane, Washington, United States
Scroll for more (8 remaining)Franco Felizarta, MD🇺🇸Bakersfield, California, United States