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Antiretroviral Therapy

B/F/TAF for HIV

Phase 1
Waitlist Available
Research Sponsored by Gilead Sciences
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 intensive pk: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (weeks 20-28), third trimester (weeks 30-38), week 6 post-partum, and week 12 post-partum
Awards & highlights
No Placebo-Only Group

Summary

The primary objective of this study is to evaluate the steady state PK of bictegravir (BIC) and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed pregnant women in their second and third trimesters.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC)
Secondary study objectives
PK Parameter: AUClast of BIC, FTC, and TAF
PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
PK Parameter: CLss/F of BIC, FTC, and TAF
+9 more

Side effects data

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: B/F/TAFExperimental Treatment1 Intervention
Pregnant women participants will receive fixed dose combination (FDC) tablet of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
Group II: NeonatesActive Control1 Intervention
Neonates who will be born to women participants in the study will be followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates that participate in the study will be treated with the study drug.
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
1,129 Previous Clinical Trials
867,521 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
356 Previous Clinical Trials
191,560 Total Patients Enrolled
~10 spots leftby Oct 2025
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