Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

872

Participants

Timeline

Start Date

March 12, 2013

Primary Completion Date

September 19, 2014

Study Completion Date

October 3, 2018

Conditions
HIVHIV Infections
Interventions
DRUG

E/C/F/TAF

150/150/200/10 mg FDC tablet administered orally once daily

DRUG

E/C/F/TDF

150/150/200/300 mg FDC tablet administered orally once daily

DRUG

E/C/F/TDF Placebo

Tablet administered orally once daily

DRUG

E/C/F/TAF Placebo

Tablet administered orally once daily

Trial Locations (117)

10011

Chelsea Village Medical, New York

10032

Columbia University Medical Center, New York

10065

Weill Cornell Medical College, New York

10461

Jacobi Medical Center, The Bronx

10467

Montefiore Medical Center, The Bronx

11030

North Shore University Hospital - Division of Infectious Diseases, Manhasset

11883

Venhalsan / Sodersjukhuset, Stockholm

12208

Albany Medical College, Albany

Upstate ID Assoc, Albany

14080

"Insituto Nacional De Enfermedades Respiratorias Ismael Cosio Villegas", Mexico City

14186

Karolinska University Hospital, Huddinge, Stockholm

19104

University of Pennsylvania, Philadelphia

20009

Dupont Circle Physicians Group, Washington D.C.

Whitman-Walker Health, Washington D.C.

20036

Capital Medical Associates, PC, Washington D.C.

20037

Medical Faculty Associates, Washington D.C.

20132

IRCCS Ospedale San Raffaele, Milan

22003

Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID), Annandale

27157

Wake Forest University Health Sciences, Winston-Salem

27599

University of North Carolina AIDS Clinical Trials Unit, Chapel Hill

27710

Duke University Medical Center, Durham

27834

East Carolina University The Brody School of Medicine, Greenville

28078

Rosedale Infectious Disseases, Huntersville

28207

Carolinas Medical Center Myer's Park Clinic, Charlotte

30033

Infectious Disease Specialist of Atlanta, Decatur

30308

AIDS Research Consortium of Atlanta, Atlanta

30309

Atlanta ID Group, PC, Atlanta

Emory University, Atlanta

30912

Georgia Regents University, Augusta

31201

Mercer University, Macon

32504

Infectious Diseases Associates of NW FL, Sarasota

32803

Orlando Immunology Center, Orlando

32836

Idocf/Valuhealthmd, Orlando

33133

AIDS Healthcare Foundation, Miami

33139

AIDS Healthcare Foundation, Miami Beach

33316

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

33401

Triple O Research Institute PA, West Palm Beach

33602

University of South Florida, Tampa

33614

Infectious Disease Research Institute Inc., Tampa

St. Joseph's Comprehensive Research Institute, Tampa

34295

University Hospital of Montpellier (CHU-Gui de Chauliac), Montpellier

34952

Midway Immunology and Research Center, Ft. Pierce

35294

University of Alabama at Birmingham, Birmingham

40138

Universitaria di Bologna-Policlicnico S' Orsola Malpighi, Bologna

44280

Hospital Civil de Guadalajara, Guadalajara

48202

Henry Ford Health System, Detroit

55415

Hennepin County Medical Center, Minneapolis

59208

CH Tourcoing, Tourcoing

60305

Rush University Medical Center, Section of Infectious Diseases, Chicago

60612

The Ruth M. Rothstein CORE Center, Chicago

63108

Central West Clinical Research, St Louis

63139

Southampton Healthcare, Inc., St Louis

69004

Hopital de la Croix Rousse, Lyon

75010

Saint Louis Hospital of Infectious Diseases, Paris

75012

Hopital Saint Antoine, Paris

75018

Hôpital Bichat Claude Bernard, Paris

75020

Hopital Tenon, Paris

75215

Trinity Health & Wellness Center / AIDS Arms, Inc., Dallas

75219

Southwest Infectious Disease Clinical Research, Inc., Dallas

75246

North Texas Infectious Diseases Consultants, Dallas

75605

DCOL Center for Clinical Research, Longview

75651

Hopital Pitie Salpetriere, Paris

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts, PA, Houston

77098

Gordon E. Crofoot, MD, PA, Houston

Research Access Network, Houston

77401

St. Hope Foundation, Inc., Bellaire

78705

Central Texas Clinical Research, Austin

80045

University of Colorado, Aurora

80209

APEX Research LLC, Denver

85012

Spectrum Medical Group, Phoenix

87505

Southwest CARE Center, Santa Fe

90027

Kaiser Permanente - Los Angeles Medical Center, Los Angeles

90033

University of Southern California AIDS Clinical Trials Group, Los Angeles

90036

Peter J. Ruane, Inc., Los Angeles

90069

Anthony Mills MD Inc, Los Angeles

90275

Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center, Torrance

92103

La Playa Medical Group and Clinical Research, San Diego

94118

Kaiser Permanente San Francisco, San Francisco

94304

Stanford University, Palo Alto

94577

Kaiser Permanente, San Leandro

94602

Alameda County Medical Center, Oakland

95817

University of California, Davis Medical Center, Sacramento

95825

Kaiser Permanente Medical Group, Sacramento

96821

University of Hawaii - Hawaii Center for AIDS, Honolulu

98104

Peter Shalit, MD, Seattle

99999

Instituto Dominicano de Estudios Virologicos--IDEV, Santo Domingo

06830

Greenwich Hospital, Greenwich

06510

Yale University, New Haven

02111

Community Research Initiative of New England, Boston

01105

The Research Institute, West Springfield

48072-3436

Be Well Medical Center, Berkley

08844

ID Care, Hillsborough

02906

The Miriam Hospital, Providence

H2X 2P4

Research Institute of McGill University Health Care, Montreal

H2L 4P9

Clinique Medicale L'actuel, Montreal

M4N 3M5

University Health Network/Toronto General Hospital, Toronto

M5G 1K2

Maple Leaf Research, Toronto

V6Z 2T1

Spectrum Health Care, Vancouver

06200

Archet 1 CHU de Nice, Department of Infectiology, Nice

1091 AC

Onze Lieve Vrouwe Gasthuis, Amsterdam

3000-075

Serviço de Doenças Infecciosas, HUC-CHUC, EPE, Coimbra

1169-050

Hospital Santo Antonio dos Capuchos, Lisbon

1649-035

Hospital de Santa Maria - CHLN, EPE, Lisbon

4369-004

Centro Hospitalar do Porto - Hospital Joaquim Urbano, Porto

00909

Hope Clinical Research, San Juan

00935

University of Puerto Rico ACTU, San Juan

B4 6DH

Whittall Street Clinic, Birmingham

B9 5SS

Heart Of England NHS Foundation Trust, Birmingham

BN2 1ES

Brighton and Sussex University Hospitals NHS Trust, Brighton

G12 0YN

Brownlee Centre, Gartnavel General Hospital, Glasgow

E11BB

Barts Health NHS Trust, London

NW3 2QG

Royal Free London NHS Foundation Trust, London

SE5 9RJ

Kings College Hospital, London

SW10 9NH

Chelsea and Westminster, London

WC1E 6JB

Mortimer Market Centre, London

M8 5RB

North Manchester General Hospital, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY