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Antiretroviral Therapy

B/F/TAF Oral Therapy for HIV

Phase 4
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights

Summary

This trial is testing a switch from an injection to an oral therapy to help people living with HIV stay healthy.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include gastrointestinal issues like nausea or diarrhea, headaches, fatigue, and possible allergic reactions. Long-term risks could involve kidney problems, bone density loss, or liver complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My HIV is under control with CAB+RPV injections every 2 months.
Select...
I am on a 2-month CAB+RPV injection schedule and haven't missed any doses.
Select...
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?
Select...
My condition shows no resistance to BIC, FTC, or TFV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
HIV Treatment Satisfaction Questionnaire Change (HIVTSQc) Total Score at Week 4
Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Discontinuation = Failure Approach
Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Missing = Excluded Approach
+2 more

Side effects data

From 2023 Phase 4 trial • 28 Patients • NCT03797014
18%
Upper respiratory tract infection
7%
Abdominal pain
7%
Abscess, extremity
7%
Back pain
7%
Headache
7%
Hypertension
7%
Nausea
7%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
B/F/TAF

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
B/F/TAF
2016
Completed Phase 4
~5170

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,098 Previous Clinical Trials
860,434 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
351 Previous Clinical Trials
189,325 Total Patients Enrolled
~6 spots leftby Dec 2024
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