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NCT02881320 · ClinicalTrials.gov registry record · Phase 2

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1

A Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.

Active
Registry status
Phase 2
Development phase
177
Enrollment target
20
Study locations

NCT02881320 is a Phase 2 study of HIV-1-infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 177 participants, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT02881320, a Phase 2 study of HIV-1-infection, is active but no longer recruiting, sponsored by Gilead Sciences.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
177 participants
Enrollment target
20
Study locations

Study Summary

The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and children with HIV-1.

Conditions Studied

HIV-1-infection

Interventions

  • DRUG B/F/TAF (Adult Strength)
  • DRUG B/F/TAF (Low Dose)
  • DRUG B/F/TAF (TOS)

Study Locations (20)

Other

  • Department of Paediatrics and Child Health - Bloemfontein
  • Be Part Ypluntu Centre - Cape Town
  • FAMCRU, Ward J8 - CapeTown
  • Dr. J Fourie Medical Centre - Dundee
  • Enhancing Care Foundation, Durban International Clinical Research Site - Durban
  • Wits RHI Shandukani Research Centre, Wits Reproductive Health & HIV Institute - Johannesburg
  • Empilweni Service and Research Unit (ESRU) - Johannesburg
  • VX Pharma(Pty) Ltd - Pretoria
  • Perinatal HIV Research Unit - Soweto
  • The HIV Netherlands Australia Thailand Research Collaboration - Bangkok

Florida

  • Midway Immunology and Research Center - Ft. Pierce
  • University of Florida Health - Gainesville
  • USF Clinic at Children's Medical Services (study visits and drug storage) - Tampa

District of Columbia

  • Children's National Health System - Washington D.C.

Georgia

  • Grady Health System Ponce Center Family and Youth Clinic - Atlanta

Michigan

  • Wayne Pediatric Clinic - Detroit

New York

  • Bellevue Hospital - New York

North Carolina

  • Duke Children's Health Center, Pediatric Infectious Diseases - Durham

Pennsylvania

  • St. Christopher's Hospital for Children/Section of Immunology - Philadelphia

Trial Details

FieldValue
Enrollment Target 177 participants
Start Date 2016-09-21
Est. Completion 2026-11
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02881320

The ClinicalTrials.gov registry entry for NCT02881320 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 177 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (49% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 3 interventions - of which B/F/TAF (Adult Strength) is the first listed.

NCT02881320 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Florida, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT02881320 about?

NCT02881320 is a clinical study titled "Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1". The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide FDC in adolescents and...

What is the current status of trial NCT02881320?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 177 participants. The study started on 2016-09-21. Estimated completion is 2026-11.

What conditions does trial NCT02881320 study?

This clinical trial studies the following conditions: HIV-1-infection.

What interventions are being tested in trial NCT02881320?

The interventions under investigation include: B/F/TAF (Adult Strength) (DRUG), B/F/TAF (Low Dose) (DRUG), B/F/TAF (TOS) (DRUG).

Who is sponsoring clinical trial NCT02881320?

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

Where is trial NCT02881320 being conducted?

This trial has 20 study locations across District of Columbia, Florida, Georgia, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.