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NCT03960645 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

A Phase 1 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 1
Development phase
62
Enrollment target

NCT03960645 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 62 participants.

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The verdict

NCT03960645, a Phase 1 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 1
Development phase
62 participants
Enrollment target

Study 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.

Interventions

  • DRUG B/F/TAF

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2019-06-28
Est. Completion 2022-08-18
Phase Phase 1

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT03960645

The ClinicalTrials.gov registry entry for NCT03960645 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which B/F/TAF is the first listed.

NCT03960645 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03960645 about?

NCT03960645 is a clinical study titled "Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters". 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 trimest...

What is the current status of trial NCT03960645?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2019-06-28. Estimated completion is 2022-08-18.

What interventions are being tested in trial NCT03960645?

The interventions under investigation include: B/F/TAF (DRUG).

Who is sponsoring clinical trial NCT03960645?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.