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AzTrials

HIV-1-infectionPhase 3NCT03110380

Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

A Phase 3 study testing B/F/TAF, F/TAF and DTG in people with HIV-1-infection, run by Gilead Sciences at 94 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1-infection
What is being tested?
B/F/TAF, F/TAF and DTG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
567 participants
Where
94 sitesin 6 countries
Study dates
12 Jun 2017to 10 Feb 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum time periods:
  • ≥ 6 months (if there is documented or suspected nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance prior to the screening visit)
  • ≥ 3 months (if there is no documented or suspected NRTI resistance prior to the screening visit)
  • Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with DTG+F/TAF or DTG+F/TDF (for a minimum period of ≥ 6 or ≥ 3 months, as applicable) preceding the screening visit
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening visit
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
Show all 9Show fewer
  • No documented resistance to integrase stand transfer inhibitors (INSTIs) or confirmed virologic failure
  • Eligible adults with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection are permitted to enroll
  • NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Who cannot join

None listed.

Trial locations and contacts

94 sites in 6 countries.

94 sites in 6 countries

United States66 sites

  • Southwest CARE Center

    Albuquerque, New Mexico, 87109

  • Emory Hospital Midtown Infectious Disease Clinic

    Atlanta, Georgia, 30308

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30312

  • AU Medical Center

    Augusta, Georgia, 30912

  • University of Colorado Denver, University of Colorado Hospital

    Aurora, Colorado, 80045

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Community Research Initiative of New England

    Boston, Massachusetts, 02129

  • NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Palmetto Health Richland (Regulatory and Study Supply Shipping)

    Columbia, South Carolina, 29203

  • AIDS Arms Inc/ Trinity Health and Wellness Center

    Dallas, Texas, 75208

  • North Texas Infectious Diseases Consultants, P.A.

    Dallas, Texas, 75246

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida, 32720

  • Duke University Heath System

    Durham, North Carolina, 27710

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Gary J. Richmond, M.D., P.A.

    Fort Lauderdale, Florida, 33316

  • Metro West Medical Center

    Framingham, Massachusetts, 01702

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • East Carolina University (ECU), The Brody School of Medicine, Adult Specialty Care

    Greenville, North Carolina, 27834

  • John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako

    Honolulu, Hawaii, 96813

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Research Access Network

    Houston, Texas, 77098

  • The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)

    Houston, Texas, 77098

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • Kansas City CARE Clinic

    Kansas City, Missouri, 64111

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Ruane Clinical Research Group Inc.

    Los Angeles, California, 90036

  • Mills Clinical Research

    Los Angeles, California, 90069

  • University of Louisville 550 Clinic

    Louisville, Kentucky, 40202

  • Mercer University, Department of Internal Medicine

    Macon, Georgia, 31201

  • North Shore University Hospital/Division of Infectious Diseases

    Manhasset, New York, 11030

  • University of Miami Divison of Infectious Diseases Clinical Research Unit

    Miami, Florida, 33136

  • AIDS Healthcare Foundation - South Beach

    Miami Beach, Florida, 33140

  • Abbott Northwestern Hospital part of Allina Health

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center, Positive Care Clinic

    Minneapolis, Minnesota, 55415

  • Prime Healthcare Services - St. Michael's LLC d/b/a Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Highland Hospital - Alameda Health System

    Oakland, California, 94602

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • AHF-Pensacola

    Pensacola, Florida, 32503

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • Cares Community Health

    Sacramento, California, 95814

  • Kaiser Permanente

    Sacramento, California, 95825

  • Hepatitis/HIV Clinical Trials Group (HHCTG)

    San Francisco, California, 94110

  • Kaiser Permanente

    San Francisco, California, 94118

  • Kaiser Permanente, Department of Infectious Diseases

    San Leandro, California, 94577

  • Southwest CARE Center

    Santa Fe, New Mexico, 87505

  • Chatham County Health Department

    Savannah, Georgia, 31401

  • Peter Shalit, M.D.

    Seattle, Washington, 98104

  • MultiCare Rockwood HIV Critical Care Clinic

    Spokane, Washington, 99204

  • Claudia T Martorell, MD., LLC d/b/a The Research Institute

    Springfield, Massachusetts, 01105

  • Southampton Healthcare, Inc.

    St Louis, Missouri, 63139

  • Infectious Disease Research Institute Inc

    Tampa, Florida, 33614

  • St. Joseph's Hospital Comprehensive Research Institute

    Tampa, Florida, 33614

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • AIDS Research and Treatment Center of the Treasure Coast

    Vero Beach, Florida, 32960

  • Whitman-Walker Institute

    Washington D.C., District of Columbia, 20005

  • Dupont Circle Physician's Group

    Washington D.C., District of Columbia, 20009

  • Providence Hospital Center for Infectious Diseases

    Washington D.C., District of Columbia, 20017

  • The GW Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33407

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany9 sites

  • zibp Zentrum für Infektiologie Berlin Prenzlauer Berg

    Berlin, 10439

  • EPIMED Gesellschaft fur epidemiologische und klinische Forschung in der Medizin mbH

    Berlin, 12157

  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Immunologie

    Bonn, 53127

  • Universitätsklinikum Köln - Klinik I fur Innere Medizin - Klinisches Studienzentrum fur Infektiologie I

    Cologne, 50937

  • Universitätsklinikum Essen - Klinik fur Dermatologie und Venerologie - HPSTD Ambulanz

    Essen, 45122

  • Universitätsklinikum Frankfurt, Medizinische Klinik II, Schwerpunkt Infektiologie, Haus 68

    Frankfurt am Main, 60590

  • Infektiologikum Frankfurt

    Frankfurt am Main, 60596

  • ICH Study Center GmbH & Co. KG

    Hamburg, 20146

  • Universitätsklinikum Hamburg- Eppendorf - Ambulanzzentrum des Universitatsklinikums Eppendorf GmbH - Bereich Infektiologie

    Hamburg, 20246

Other trials in Germany

France8 sites

  • Hôpital Saint-André

    Bordeaux, 33075

  • Hôpital Croix-Rousse

    Lyon, 69004

  • Hôpital Gui de Chauliac, CHU de Montpellier

    Montpellier, 34295

  • CHU de Nice-l'Archet

    Nice, 06202

  • CHU Bichat

    Paris, 75018

  • AP-HP Hôpital Tenon

    Paris, 75020

  • Hôpital Saint-Louis

    Paris, 75475

  • Hôpital Saint-Antoine

    Paris, 75571

Other trials in France

Canada6 sites

  • Kaye Edmonton Clinic

    Edmonton, Alberta, T6G 2G3

  • Clinique de Médecine Urbaine du Quartier Latin

    Montreal, Quebec, H2L 5B1

  • Chronical Viral Illness Service/McGill University Health Care (MUHC)

    Montreal, Quebec, H4A 3J1

  • Maple Leaf Research / Maple Leaf Medical Clinic

    Toronto, Ontario, M5G 1K2

  • Spectrum Health Clinic

    Vancouver, British Columbia, 6Z 2T1

  • Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Puerto Rico4 sites

  • Instituto de Investigacion Cientifica del Sur

    Ponce, 00730

  • Hope Clinical Research

    San Juan, 00909

  • Proyecto ACTU

    San Juan, 00935

  • Clinical Research Puerto Rico

    San Juan, 909

Other trials in Puerto Rico

Austria1 site

  • Medizinische Universitat Wien, Universitatsklinik fur Dermatologie

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.

Conditions
HIV-1-infection
Being tested
B/F/TAF, F/TAF, DTG, DTG Placebo, F/TAF Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B/F/TAFDrug

    Also called GS-9883/F/TAF, Biktarvy®

    50/200/25 mg FDC tablet(s) administered orally once daily

  • F/TAFDrug

    Also called Descovy®

    200/25 mg FDC tablet(s) administered orally once daily

  • DTGDrug

    Also called Tivicay®

    50 mg tablet(s) administered orally once daily

  • DTG PlaceboDrug

    Tablet(s) administered orally once daily

  • F/TAF PlaceboDrug

    Tablet(s) administered orally once daily

  • B/F/TAF PlaceboDrug

    Tablet(s) administered orally once daily

Study groups in NCT03110380
Study groupRoleWhat they receive
B/F/TAFExperimentalBictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered without regard to food for at least 48 weeks.
Receives: Drug: B/F/TAF; Drug: DTG Placebo; Drug: F/TAF Placebo
DTG + F/TAFActive comparatorDTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks.
Receives: Drug: F/TAF; Drug: DTG; Drug: B/F/TAF Placebo
Open-label Phase B/F/TAF from B/F/TAFExperimentalParticipants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Receives: Drug: B/F/TAF
Open-label Phase B/F/TAF from DTG + F/TAFExperimentalParticipants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Receives: Drug: B/F/TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

    The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Measured: Week 48

Secondary outcomes (2)

  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Measured: Week 48

  2. Change From Baseline in CD4+ Cell Count at Week 48

    Measured: Baseline; Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start12 Jun 2017
  3. Primary completion4 Dec 2018
  4. Study completion10 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
567 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03110380
Sponsor's protocol ID
GS-US-380-4030
Other IDs
2017-000308-17, 2017
Status last verified
Dec 2021
First submitted
7 Apr 2017
Last updated
11 Jan 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

Publications

  • Sax PE, Rockstroh JK, Luetkemeyer AF, Yazdanpanah Y, Ward D, Trottier B, Rieger A, Liu H, Acosta R, Collins SE, Brainard DM, Martin H; GS-US-380-4030 Investigators. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Jul 15;73(2):e485-e493. doi: 10.1093/cid/ciaa988.

    PubMed 32668455

  • Acosta RK, Willkom M, Andreatta K, Liu H, Martin R, Parvangada A, Martin H, Collins S, White KL. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Dolutegravir (DTG)+F/TAF or DTG+F/Tenofovir Disoproxil Fumarate (TDF) in the Presence of Pre-existing NRTI Resistance. J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):363-371. doi: 10.1097/QAI.0000000000002454.

    PubMed 32701823

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing B/F/TAF, F/TAF and DTG in people with HIV-1-infection, run by Gilead Sciences at 94 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Germany, France, Canada, Puerto Rico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03110380, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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