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

PHASE3CompletedINTERVENTIONAL
Enrollment

567

Participants

Timeline

Start Date

June 12, 2017

Primary Completion Date

December 4, 2018

Study Completion Date

February 10, 2021

Conditions
HIV-1-infection
Interventions
DRUG

B/F/TAF

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

DRUG

F/TAF

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

DRUG

DTG

50 mg tablet(s) administered orally once daily

DRUG

DTG Placebo

Tablet(s) administered orally once daily

DRUG

F/TAF Placebo

Tablet(s) administered orally once daily

DRUG

B/F/TAF Placebo

Tablet(s) administered orally once daily

Trial Locations (94)

909

Clinical Research Puerto Rico, San Juan

1090

Medizinische Universitat Wien, Universitatsklinik fur Dermatologie, Vienna

10439

zibp Zentrum für Infektiologie Berlin Prenzlauer Berg, Berlin

10461

Jacobi Medical Center, The Bronx

10467

Montefiore Medical Center, The Bronx

11030

North Shore University Hospital/Division of Infectious Diseases, Manhasset

12157

EPIMED Gesellschaft fur epidemiologische und klinische Forschung in der Medizin mbH, Berlin

20005

Whitman-Walker Institute, Washington D.C.

20009

Dupont Circle Physician's Group, Washington D.C.

20017

Providence Hospital Center for Infectious Diseases, Washington D.C.

20037

The GW Medical Faculty Associates, Washington D.C.

20146

ICH Study Center GmbH & Co. KG, Hamburg

20246

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

27157

Wake Forest Baptist Health, Winston-Salem

27514

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

27710

Duke University Heath System, Durham

27834

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

28078

Rosedale Infectious Diseases, Huntersville

29203

Palmetto Health Richland (Regulatory and Study Supply Shipping), Columbia

29425

Medical University of South Carolina (MUSC), Charleston

30033

Infectious Disease Specialists of Atlanta, Decatur

30308

Emory Hospital Midtown Infectious Disease Clinic, Atlanta

30312

AIDS Research Consortium of Atlanta, Atlanta

30912

AU Medical Center, Augusta

31201

Mercer University, Department of Internal Medicine, Macon

31401

Chatham County Health Department, Savannah

32503

AHF-Pensacola, Pensacola

32720

Midland Florida Clinical Research Center, LLC, DeLand

32803

Orlando Immunology Center, Orlando

32960

AIDS Research and Treatment Center of the Treasure Coast, Vero Beach

33075

Hôpital Saint-André, Bordeaux

33136

University of Miami Divison of Infectious Diseases Clinical Research Unit, Miami

33140

AIDS Healthcare Foundation - South Beach, Miami Beach

33308

Therafirst Medical Center, Fort Lauderdale

33316

Gary J. Richmond, M.D., P.A., Fort Lauderdale

33407

Triple O Research Institute, P.A., West Palm Beach

33614

Infectious Disease Research Institute Inc, Tampa

St. Joseph's Hospital Comprehensive Research Institute, Tampa

34295

Hôpital Gui de Chauliac, CHU de Montpellier, Montpellier

34982

Midway Immunology and Research Center, Ft. Pierce

40202

University of Louisville 550 Clinic, Louisville

45122

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

48072

Be Well Medical Center, Berkley

50937

Universitätsklinikum Köln - Klinik I fur Innere Medizin - Klinisches Studienzentrum fur Infektiologie I, Cologne

53127

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

55407

Abbott Northwestern Hospital part of Allina Health, Minneapolis

55415

Hennepin County Medical Center, Positive Care Clinic, Minneapolis

60590

Universitätsklinikum Frankfurt, Medizinische Klinik II, Schwerpunkt Infektiologie, Haus 68, Frankfurt am Main

60596

Infektiologikum Frankfurt, Frankfurt am Main

63139

Southampton Healthcare, Inc., St Louis

64111

Kansas City CARE Clinic, Kansas City

69004

Hôpital Croix-Rousse, Lyon

75018

CHU Bichat, Paris

75020

AP-HP Hôpital Tenon, Paris

75208

AIDS Arms Inc/ Trinity Health and Wellness Center, Dallas

75246

North Texas Infectious Diseases Consultants, P.A., Dallas

75475

Hôpital Saint-Louis, Paris

75571

Hôpital Saint-Antoine, Paris

75605

DCOL Center for Clinical Research, Longview

77004

Therapeutic Concepts, PA, Houston

77098

Research Access Network, Houston

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

78705

Central Texas Clinical Research, Austin

80045

University of Colorado Denver, University of Colorado Hospital, Aurora

85012

Spectrum Medical Group, Phoenix

87109

Southwest CARE Center, Albuquerque

87505

Southwest CARE Center, Santa Fe

90036

Ruane Clinical Research Group Inc., Los Angeles

90069

Mills Clinical Research, Los Angeles

94110

Hepatitis/HIV Clinical Trials Group (HHCTG), San Francisco

94118

Kaiser Permanente, San Francisco

94577

Kaiser Permanente, Department of Infectious Diseases, San Leandro

94602

Highland Hospital - Alameda Health System, Oakland

95814

Cares Community Health, Sacramento

95825

Kaiser Permanente, Sacramento

96813

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

98104

Peter Shalit, M.D., Seattle

99204

MultiCare Rockwood HIV Critical Care Clinic, Spokane

02115

Brigham and Women's Hospital, Boston

02118

Boston Medical Center, Boston

02129

Community Research Initiative of New England, Boston

01702

Metro West Medical Center, Framingham

01105

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

07102

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

T6G 2G3

Kaye Edmonton Clinic, Edmonton

6Z 2T1

Spectrum Health Clinic, Vancouver

R3A 1R9

Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg, Winnipeg

M5G 1K2

Maple Leaf Research / Maple Leaf Medical Clinic, Toronto

H2L 5B1

Clinique de Médecine Urbaine du Quartier Latin, Montreal

H4A 3J1

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

06202

CHU de Nice-l'Archet, Nice

00730

Instituto de Investigacion Cientifica del Sur, Ponce

00909

Hope Clinical Research, San Juan

00935

Proyecto ACTU, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT03110380 - 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 | Biotech Hunter | Biotech Hunter