B/F/TAF Oral Therapy for HIV

Recruiting at 17 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Gilead Sciences

Must be taking: CAB+RPV

Must not be taking: Immunosuppressants, Chemotherapeutics

Disqualifiers: B/F/TAF intolerance, INSTI failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

33 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

This trial is for people with HIV-1 who have undetectable viral levels and are currently on CAB+RPV injections but want to switch to or need an oral medication due to side effects, inconvenience, or other reasons. Participants should be virologically suppressed for at least 6 months and have no resistance to the study drugs.

Inclusion Criteria

My HIV is under control with CAB+RPV injections every 2 months.

I am on a 2-month CAB+RPV injection schedule and haven't missed any doses.

I can start B/F/TAF treatment up to 7 days before my next CAB+RPV dose.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch to an oral therapy of B/F/TAF from CAB+RPV and receive a fixed dose combination of B/F/TAF 50/200/25 mg once daily

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bictegravir/Emtricitabine/Tenofovir (B/F/TAF)

Trial Overview The EMPOWER study is testing the safety and effectiveness of switching from injectable Cabotegravir + Rilpivirine (CAB+RPV) treatment to an oral regimen of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) in individuals whose HIV-1 virus is already well-controlled.

Participant Groups

Group I: B/F/TAF Experimental Treatment 1 Intervention

Participants will receive a fixed dose combination of B/F/TAF 50/200/25 mg once daily for 24 weeks

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine