Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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]
- Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 12 (Co-Primary Endpoint) [First dose up to Week 12]
Secondary Outcome Measures
- Plasma Concentrations of Bictegravir (BIC), Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1 [Day 1]
- Plasma Concentration of BIC, CAB, and RPV at Week 4 [Week 4]
- Plasma Concentration of BIC, CAB, and RPV at Week 12 [Week 12]
- Plasma Concentration of BIC, CAB, and RPV at Week 24 [Week 24]
- 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.
- 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.
- 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 12 [Up to 12 Weeks]
- Percentage of Participants with Discontinuation of B/F/TAF by Week 24 [Up to 24 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.
Eligibility Criteria
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
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Currently virologically suppressed (HIV-1 RNA < 50 copies/mL) on CAB+RPV IM injections every 2 months
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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:
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History of B/F/TAF intolerance
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History of previous INSTI virologic failure including CAB+RPV
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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
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GS-US-380-6738
- 2023-506660-13