Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

PHASE3CompletedINTERVENTIONAL
Enrollment

1,443

Participants

Timeline

Start Date

March 27, 2013

Primary Completion Date

March 16, 2015

Study Completion Date

April 1, 2020

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

EFV/FTC/TDF

600/200/300 mg FDC tablet administered orally once daily

DRUG

RTV

100 mg tablet administered orally once daily

DRUG

ATV

300 mg capsule administered orally once daily

DRUG

FTC/TDF

200/300 mg tablet administered orally once daily

DRUG

COBI

150 mg tablet administered orally once daily

Trial Locations (167)

1000

CHU Saint-Pierre University Hospital, Brussels

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

1070

Hôpital Universitaire Erasme - ULB, Ghent

1090

Medizinische Universitat Wien, Vienna

1140

SMZ Baumgartner Hoehe - Otto-Wagner-Spital, Vienna

2010

East Sydney Doctors, Darlinghurst

Holdsworth House Medical practice, Darlinghurst

St Vincent's Hospital, Sydney, Darlinghurst

Taylor Square Private Clinic, Darlinghurst

Albion Street Centre, Surry Hills

2100

Epidemiklinikken 5112, Rigshospitalet, Copenhagen

3004

Alfred Hospital, Melbourne

3010

Universitätsklinik für Infektiologie, Universitätsspital Bern, Bern

3053

Melbourne Sexual Health Clinic, Carlton

3068

Northside Clinic, Melbourne

3141

Prahran Market Clinic, South Yarra

8020

Medizinische Universität Graz, Graz

8091

University Hospital of Zurich, Zurich

10003

Beth Israel Medical Center- Division of Infectious Diseases, New York

10011

Chelsea Village Medical, PC, New York

Ricky K. Hsu, MD, New York

10149

Comprensorio Amedeo Di Savoia Birago Di Vische, Torino

10330

HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University, Bangkok

10400

Ramathibodi Hospital, Mahidol University, Bangkok

10461

Jacobi Medical Center, The Bronx

10467

Montefiore Medical Center - AIDS Center, The Bronx

10550

Greiger Clinic, Mount Vernon

10700

Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine, Bangkok

11030

North Shore University Hospital, Divison of Infectious Diseases, Manhasset

11355

New York Hospital Queens, Flushing

11883

Södersjukhuset, Stockholm

12157

EPIMED GmbH, Berlin

12208

Upstate ID Association, Albany

12209

Albany Medical College, Albany

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

20009

Dupont Circle Physicians Group, Washington D.C.

Whitman Walker Clinic, Washington D.C.

20036

Capital Medical Associates, PC, Washington D.C.

20037

George Washington University Medical Faculty Associates, Washington D.C.

20127

Fondazione Centro San Raffaele del Monte Tabor, Milan

20146

ICH Study Center Hamburg, Hamburg

20157

Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive, Milan

20246

University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit, Hamburg

22003

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

27599

University of NC AIDS Clinical Trials Unit, Chapel Hill

27710

Duke University Health System, Durham

27834

East Carolina University, Greenville

28046

Hospital Universitario La Paz, Madrid

28078

Rosedale Infectious Diseases, Huntersville

28207

Carolinas Medical Center-Myers Park, Charlotte

29203

Palmetto Health Richland, Columbia

30033

Infectious Disease Specialists of Atlanta, Decatur

30308

AIDS Research Consortium of Atlanta, Atlanta

30309

Atlanta ID Group, PC, Atlanta

31201

Mercer University School of Medicine, Macon

32803

Orlando Immunology Center, Orlando

32806

IDOCF/ Value Health MD, LLC, Orlando

33133

The Kinder Medical Group, Miami

33139

Wohlfeiler, Piperato and Associates, LLC, Miami Beach

33308

Therafirst Medical Center, Fort Lauderdale

33311

Broward Health/Comprehensive Care Center, Fort Lauderdale

33316

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

33602

University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department, Tampa

33614

Infectious Disease Research Institute Inc., Tampa

33615

St. Joseph's Comprehensive Research Institute, Tampa

34982

Midway Immunology and Research Center, Ft. Pierce

35294

University of Alabama at Birmingham, Birmingham

40002

Khon Kaen University, Khon Kaen

40237

Center for HIV and Hepatogastroenterology, Düsseldorf

41013

Hospital Virgen del Rocio, Seville

44093

CHU Hotel Dieu, Nantes

44280

"Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde", Guadalajara

44304

Summa Health System, Akron

48072

Be Well Medical Center, Berkley

48202

Henry Ford Health System, Detroit

50200

Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine, Chiang Mai

50937

University of Cologne, Department of Internal Medicine, Cologne

53127

University of Bonn, Bonn

53226

Medical College of Wisconsin, Milwaukee

55415

Hennepin County Medical Center, Minneapolis

59208

Centre Hospitalier de Tourcoing, Tourcoing

60311

Infektio Research GmbH / Infektiologikum Frankfurt, Frankfurt am Main

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

60612

Ruth M. Rothstein CORE Center, Chicago

60613

Howard Brown Health Center, Chicago

60657

NorthStar Medical Center, Chicago

63108

Central West Clinical Research, St Louis

63110

Saint Louis University, St Louis

63139

Southampton Healthcare, St Louis

72207

Health for Life Clinic PLLC, Little Rock

75010

Hôpital Saint Louis, Paris

75012

Hopital Saint Antoine, Paris

75018

Bichat Hospital, Paris

75215

AIDS Arms, Inc./ Peabody Health Center, Dallas

75219

Southwest Infectious Disease Clinical Research, Inc., Dallas

75605

DCOL Center for Clinical Research, Longview

75970

Hôpital de La Croix Rousse, Lyon

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts, P.A., Houston

77098

Gordon E. Crofoot MD PA, Houston

Research Access Network, Houston

78550

Garcia's Family Health Group, Harlingen

79106

Universitatsklinikum Freiburg, Freiburg im Breisgau

80209

Apex Research LLC, Denver

80335

MUC Research GmbH, München

85006

Southwest Center for HIV/AIDS, Phoenix

85012

Spectrum Medical Group, Phoenix

87505

SouthWest CARE Center, Santa Fe

90027

Kaiser Permanente, Los Angeles

90028

Jeffrey Goodman Special Care Clinic, Los Angeles

90036

Peter J Ruane, MD, Inc, Los Angeles

90069

Anthony Mills MD Inc, Los Angeles

90211

AHF Research Center, Beverly Hills

90813

Living Hope Clinical Foundation, Long Beach

92103

La Playa Medical Group and Clinical Research, San Diego

92626

Michael Keith Wensley, MD, Inc., A Medical Corporation, Costa Mesa

92663

Orange Coast Medical Group, Newport Beach

94109

Metropolis Medical Group, San Francisco

94118

Kaiser Permanente Medical Center, Clinical Trials Unit, San Francisco

94303

Stanford University, Palo Alto

94577

Kaiser Permanente Hospital, San Leandro

94602

Alameda County Medical Center, Oakland

94609

East Bay AIDS Center, Oakland

95817

University of California, Davis Medical Center, Sacramento

95825

Kaiser Permanente Medical Group, Sacramento

96816

University of Hawaii - Hawaii Center for AIDS, Honolulu

98104

Peter Shalit, M.D., Seattle

99202

Premier Clinical Research, Spokane

06830

Greenwich Hospital, Greenwich

06510

Yale University HIV Clinical Trials Program, New Haven

02111

Community Research Initiative of New England, Boston

01105

The Research Institute, Springfield

01199

Baystate Infectious Diseases Clinical Research, Springfield

08844

ID Care, Hillsborough

07102

Saint Michaels Medical Center, Newark

08244

South Jersey Infectious Disease, Somers Point

21040-360

Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz, Rio de Janeiro

09060-650

Faculdade de Medicina do ABC, Santo André

01246-900

São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas, São Paulo

04121-000

São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS, São Paulo

V6Z 2C7

Ubc Downtown I.D. Clinic, Vancouver

R3A 1R9

Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg, Winnipeg

K1H 8L6

Ottawa Hospital, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 1K2

Maple Leaf Research, Toronto

M5G 2N2

University Health Network, Toronto General Hospital, Toronto

H2L 4P9

Clinique medicale l'Actuel, Montreal

H2L 5B1

Clinique Medicale du Quartier Latin, Montreal

H2X 2P4

McGill University Health Centre (MUHC) - Montral Chest Institute, Montreal

H3A 1T1

Clinique OPUS, Montreal

Unknown

Instituto Dominicano de Estudios Virologicos - IDEV, Santo Domingo

06200

Archet 1 CHU de Nice - 6ème Niveau, Nice

00149

"Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS", Rome

1091 AC

Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten, Amsterdam

3000 CA

Erasmus MC, Rotterdam

1649-035

Hospital de Santa Maria, Lisbon

4202-451

Servico De Doencas Infecciosas - Hospital De Sao Joao, Porto

00909

Clinical Research Puerto Rico, San Juan

HOPE Clinical Research, San Juan

00921

VA Caribbean Healthcare System, San Juan

08907

Hospital Universitari De Bellvitge, Barcelona

BN2 1ES

Brighton and Sussex University Hospitals NHS Trust, Brighton

E1 1BB

Barts and the London NHS Trust, London

SW10 9NH

Chelsea and Westminster Hospital Foundation Trust, London

SW17 0QT

Courtyard Clinic, St. Georges Hospital, London

M8 5RB

North Manchester General Hospital, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY