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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of delivery
Awards & highlights
Study Summary
This study is evaluating whether a combination of drugs may help treat HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pharmacokinetic (PK) Parameter: AUCtau of BIC
Secondary outcome measures
PK Parameter: AUClast of BIC, FTC, and TAF
PK Parameter: AUCtau of emtricitabine (FTC) and tenofovir alafenamide (TAF)
PK Parameter: CL/F of BIC, FTC, and TAF
+8 moreSide effects data
From 2023 Phase 4 trial • 28 Patients • NCT0379701418%
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
B/F/TAF for up to approximately 38 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
B/F/TAF
2016
Completed Phase 4
~4900
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,083 Previous Clinical Trials
843,326 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,660 Total Patients Enrolled
Frequently Asked Questions
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