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

HIV-1-infection Clinical Trial

Official title:

A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104306
• Other study ID #: GS-US-380-6738
• Secondary ID: 2023-506660-13
• Status: Recruiting
• Phase: Phase 4
• Start date: December 13, 2023
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230 (GILEAD-0)
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection
• Infections

Intervention

Drug:
• B/F/TAF
Tablets administered without regard to food

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences-SIS Clinic	Hamilton
Canada	University Health Network - Toronto General Hospital	Toronto
France	CHU Bordeaux - Hopital Saint-Andre	Bordeaux
France	APHM - Hospital Sainte Marguerite	Marseille
France	CHR Orleans	Orleans
France	Centre Hospitalier Annecy Genevois	Pringy Cedex
France	HU de Strasbourg - Nouvel Hopital Civil	Strasbourg
United States	Franco Felizarta, MD	Bakersfield	California
United States	Boston Medical Center	Boston	Massachusetts
United States	Midway Immunology and Research Center	Fort Pierce	Florida
United States	Indiana University Infectious Diseases Research	Indianapolis	Indiana
United States	Las Vegas Research Center	Las Vegas	Nevada
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	Bliss Health	Orlando	Florida
United States	BIOS Clinical Research	Palm Springs	California
United States	UC San Diego AntiViral Research Center (AVRC)	San Diego	California
United States	MultiCare Rockwood Main Clinic	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Plasma Concentrations of Bictegravir (BIC), Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1		Day 1
Secondary	Plasma Concentration of BIC, CAB, and RPV at Week 4		Week 4
Secondary	Plasma Concentration of BIC, CAB, and RPV at Week 12		Week 12
Secondary	Plasma Concentration of BIC, CAB, and RPV at Week 24		Week 24
Secondary	Proportion of Participants with HIV-1 RNA = 50 Copies/mL at Week 12 as Determined by Missing = Excluded Approach	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.	Week 12
Secondary	Proportion of Participants with HIV-1 RNA = 50 Copies/mL at Week 24 as Determined by Missing = Excluded Approach	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.	Week 24
Secondary	Proportion of Participants with HIV-1 RNA = 50 Copies/mL at Week 12 as Determined by Discontinuation = Failure Approach	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.	Week 12
Secondary	Proportion of Participants with HIV-1 RNA = 50 Copies/mL at Week 24 as Determined by Discontinuation = Failure Approach	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.	Week 24
Secondary	Percentage of Participants with Discontinuation of B/F/TAF by Week 12		Up to 12 Weeks
Secondary	Percentage of Participants with Discontinuation of B/F/TAF by Week 24		Up to 24 Weeks
Secondary	Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 24		First dose up to Week 24
Secondary	HIV Treatment Satisfaction Questionnaire Change (HIVTSQc) Total Score at 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.	Week 4

External Links

•   Gilead Clinical Trials Website