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Antiretroviral Therapy

B/F/TAF Oral Therapy for HIV

Q: Are there any open opportunities for enrolment in this study?

Affirmative. Evidentiary records hosted on clinicaltrials.gov affirm that this medical experiment, which was first advertised on November 6th 2023, is currently recruiting. Approximately 35 patients need to be enrolled from one specific healthcare centre.

Q: How many people are participating in this clinical trial?

Affirmative. According to clinicaltrials.gov, this medical study is actively recruiting patients; the posting first appearing on November 6th 2023 and most recently updated on November 15th 2023. The project needs 35 individuals from one site for enrolment into the trial.

Q: Has the Food and Drug Administration given their seal of approval to B/F/TAF?

With B/F/TAF being a Phase 4 trial, it can be safely assumed that the risk of this treatment is low and thus earned itself a score of 3.

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

Study 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.Check my eligibility

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.See study design

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

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

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

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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?

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Experiencing Treatment Emergent Grade 3 or 4 Drug-related Adverse Events Through Week 12 (Co-Primary Endpoint)

Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 12 (Co-Primary Endpoint)

Secondary outcome measures

HIV Treatment Satisfaction Questionnaire Change (HIVTSQc) Total Score at Week 4

Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 24

Percentage of Participants with Discontinuation of B/F/TAF by Week 12

+9 more

Side effects data

From 2023 Phase 4 trial • 28 Patients • NCT03797014

18%

Upper respiratory tract infection

Abdominal pain

Abscess, extremity

Back pain

Headache

Hypertension

Nausea

Rash

100%

80%

60%

40%

20%

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

~4900

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

848,444 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,658 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open opportunities for enrolment in this study?

"Affirmative. Evidentiary records hosted on clinicaltrials.gov affirm that this medical experiment, which was first advertised on November 6th 2023, is currently recruiting. Approximately 35 patients need to be enrolled from one specific healthcare centre."

Answered by AI

How many people are participating in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical study is actively recruiting patients; the posting first appearing on November 6th 2023 and most recently updated on November 15th 2023. The project needs 35 individuals from one site for enrolment into the trial."

Answered by AI