B/F/TAF Oral Therapy for HIV

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Gilead Sciences

No Placebo Group

Prior Safety Data

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.

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.

It seems like there might be some information missing from your request. Could you please provide more context or clarify the criterion you'd like me to summarize?

My condition shows no resistance to BIC, FTC, or TFV.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: B/F/TAFExperimental Treatment1 Intervention

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