Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

631

Participants

Timeline

Start Date

November 13, 2015

Primary Completion Date

May 9, 2017

Study Completion Date

July 2, 2021

Conditions
HIV-1 Infection
Interventions
DRUG

ABC/DTG/3TC

600/50/300 milligrams (mg) tablets administered orally, once daily

DRUG

B/F/TAF

50/200/25 mg tablets administered orally, once daily, without regard to food

DRUG

ABC/DTG/3TC Placebo

Tablets administered orally, once daily

DRUG

B/F/TAF Placebo

Tablets administered orally, once daily

Trial Locations (121)

1200

Cliniques Universitaires Saint-Luc, Brussels

3010

Hospital General Universitario de Alicante, Alicante

10103

Instituto Dominicano de Estudios Virologicos IDEV, Santo Domingo

10457

Bronx Care, The Bronx

11030

North Shore University Hospital-(Manhasset), Manhasset

12208

Upstate Infectious Disease Associates, Albany

13353

zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH, Berlin

14004

C.H. Regional Reina Sofia - PPDS, Córdoba

14215

Evergreen Health, Buffalo

15212

Allegheny Health Network, Pittsburgh

19104

Perelman Center for Advanced Medicine, Philadelphia

19107

Philadelphia FIGHT, Philadelphia

20009

Whitman-Walker Institute, Washington D.C.

20017

Providence Hospital - DC, Washington D.C.

20036

Capital Medical Associates, Washington D.C.

20037

Medical Faculty Associates, Washington D.C.

20127

Ospedale San Raffaele S.r.l. - PPDS, Milan

20146

ICH Study Center, Hamburg

24127

ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

27401

Greensboro

27514

Aids Research Consortium of Atlanta Inc, Chapel Hill

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz - PPDS, Madrid

28078

Rosedale Infectious Diseases, Huntersville

28209

ID Consultants PA, Charlotte

30033

Infectious Disease Specialists of Atlanta, Decatur

30308

Emory University, Atlanta

30309

Atlanta Infectious Disease Group PC, Atlanta

30312

Aids Research Consortium of Atlanta Inc, Atlanta

30912

Augusta University, Augusta

31401

Chatham County Health Department, Savannah

32504

AIDS Healthcare Foundation-Miami Beach, Pensacola

32803

Orlando Immunology Center, Orlando

32960

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

33133

AHF Kinder Medical Group, Miami

33140

Miami

33308

Therafirst Medical Center, Fort Lauderdale

33316

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

33401

Triple O Research Institute PA, West Palm Beach

33614

St. Joseph's Comprehensive Research Institute, Tampa

34982

Midway Immunology and Research Center, Ft. Pierce

36312

CHUVI - H.U. Alvaro Cunqueiro, Vigo

43210

Ohio State University Medical Center, Columbus

44109

MetroHealth Research Institute, Cleveland

44304

Summa Health System, Akron

45267

University of Cincinnati, Cincinnati

46202

Indiana CTSI Clinical Research Center, Indianapolis

48072

Be Well Medical Center, Berkley

48202

Henry Ford Health System, Detroit

53127

Universitätsklinikum Bonn, Bonn

53226

The Medical College of Wisconsin, Inc., Milwaukee

55415

Hennepin County Medical Center, Minneapolis

59208

Groupe Hospitalier Bichat Claude Bernard, Tourcoing

63108

Southampton Clinical Research Group, Inc., St Louis

63139

Southampton Healthcare Inc, St Louis

64111

Kansas City CARE Clinic, Kansas City

69317

Hôpital de La Croix Rousse, Lyon

70112

Louisiana State University Health Sciences Center, New Orleans

75018

Paris

75215

AIDS Arms Inc, Dallas

75235

UT Southwestern Clinical Trials Office, Dallas

75246

North Texas Infectious Diseases Consultants PA, Dallas

75475

Hôpital Saint Louis, Paris

75571

Hôpital Saint Antoine, Paris

75605

Diagnostic Clinic of Longview Center For Clinical Research (DCOL), Longview

76104

Fort Worth

77004

Therapeutic Concepts, Houston

77098

Gordon E Crofoot MD PA, Houston

Research Access Network, Houston

77401

Saint Hope Foundation Inc, Bellaire

78705

Central Texas Clinical Research, Austin

80209

Apex Research, Denver

85012

Spectrum Medical Group, Phoenix

85015

Pueblo Family Physicians, Phoenix

87505

Santa Fe

90027

Kaiser Permanente Medical Center, Los Angeles

90036

Ruane Clinical Research Group, Inc., Los Angeles

90069

Anthony Martin Mills MD A Medical Corporation, DBA Mills Clinical Research, Los Angeles

90502

The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center, Torrance

92103

La Playa Medical Group, San Diego

94118

Kaiser Permanente, San Francisco

94577

Kaiser Permanente, San Leandro

94602

Alameda Health System- Highland Hospital, Oakland

95817

University of California Davis, Sacramento

95825

Kaiser Permanente Medical Group, Sacramento

98104

Peter Shalit MD, Seattle

99204

Multicare Rockwood HIV Critical Care Clinic, Spokane

35294-2050

University of Alabama at Birmingham, Birmingham

01199

Baystate Medical Center, Springfield

07102

Prime healthcare services - St Michael's LLC d/b/a Saint Michael's medical center, Newark

08244

South Jersey Infectious Disease, Somers Point

10467-2490

Montefiore Medical Center, The Bronx

27858-4354

East Carolina University, Greenville

27157-1042

Wake Forest Baptist Medical Center - PPDS, Winston-Salem

29203-6840

Medical University of South Carolina PPDS, Columbia

B-9000

UZ Gent, Ghent

H2L 5B1

Clinique Medicale L'actuel, Montreal

H2X 2P4

McGill University Health Center, Montreal

H3A 1T1

Clinique OPUS Inc, Montreal

K1H 8L6

Ottawa Hospital, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 1K2

Maple Leaf Research, Toronto

V6Z 2T1

Spectrum Health Care, Vancouver

R3A 1R9

Winnipeg Regional Health Authority, Winnipeg

06200

CHU de Nice Archet I, Nice

Unknown

Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS, Roma

00909

Hope Clinical Research, San Juan

00935

University of Puerto Rico, San Juan

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08907

Hospital Universitario de Bellvitge, Badalona

08036

Hospital Clinic de Barcelona, Barcelona

B4 6DH

University Hospitals Birmingham NHS Foundation Trust, Birmingham

BN2 3EW

Brighton and Sussex University Hospitals NHS Trust, Brighton

E1 1BB

Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre, London

NW3 2QG

Royal Free London NHS Foundation Trust, London

SE5 9RJ

Kings College Hospital, London

SW10 9TH

Chelsea and Westminster NHS Trust, London

WC1E 6JB

Mortimer Market Centre, London

M8 5RB

North Manchester General Hospital - PPDS, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY