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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at birth

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

Abscess, extremity

Back pain

Headache

Hypertension

Nausea

Rash

Abdominal pain

100%

80%

60%

40%

20%

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

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