Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

799

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

September 30, 2012

Study Completion Date

February 28, 2014

Conditions
HIV-1 Infection
Interventions
DRUG

FTC/RPV/TDF

Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen administered orally once daily with a meal

DRUG

EFV/FTC/TDF

Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg single-tablet regimen administered orally once daily on an empty stomach, preferably at bedtime

Trial Locations (151)

2000

Institute of Tropical Medicine, Antwerp

10003

Beth Israel Medical Center, New York

10011

Ricky K. Hsu, Md, Pc, New York

10467

Montefiore Medical Center, The Bronx

10550

Greiger Clinic, Mount Vernon

11030

North Shore University Hospital--Division of Infectious Diseases, Manhasset

11355

New York Hospital Queens, Flushing

12157

EPIMED GmbH, Berlin

12208

Upstate Infectious Disease Associates, Albany

19104

Hospital of the University of Pennsylvania, Philadelphia

19107

Philadelphia FIGHT, Philadelphia

20009

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

Whitman-Walker Clinic, Washington D.C.

20036

Capital Medical Associates, PC, Washington D.C.

20037

Medical Faculty Associates, Washington D.C.

20092

San Gerardo Hospital - Uo Malattie Infettive, Monza

20127

IRCCS Ospedale San Raffaele Centro San Luigi, Unità Operativa di Malattie Infettive, Milan

20146

ICH Study Center, Hamburg

20157

I Div Infectious Diseases, Luigi Sacco Hospital, Milan

20246

Universitätsklinikum Eppendorf Ambulanzzentrum des UKE GmbH, Infekiologie, Hamburg

21093

Johns Hopkins Rockland Physicians Practice and Research Group at Greenspring Station, Lutherville

22003

CARE-ID, Annandale

24128

Ospedali Riuniti, Bergamo

27100

"Foundation IRCCS Policlinico San Matteo Hospital", Pavia

27157

Wake Forest University Health Sciences, Winston-Salem

27599

Clinical and Translational Research Center - UNC Hospitals, Chapel Hill

27710

Duke University Medical Center, Durham

27834

The Brody School of Medicine at East Carolina University, Greenville

28041

Hospital Universitario 12 Octubre, Madrid

Unidad HIV. Hospital 12 de Octubre, Madrid

28046

Hospital La Paz, Madrid

28078

Rosedale Infectious Diseases, Huntersville

28207

Carolinas Medical Center, Charlotte

29223

University of South Carolina, Columbia

30033

Infectious Disease Specialists of America, Decatur

30306

Emory University, Atlanta

30308

AIDS Research Consortium of Atlanta, Atlanta

30309

Atlanta ID Group, Atlanta

31201

Mercer University School of Medicine, Macon

32504

Infectious Disease Associates of NW FL, Pensacola

32803

Orlando Immunology Center, Orlando

32806

Valuhealthmd,Llc / Idocf, Orlando

33133

The Kinder Medical Group, Miami

33139

Wohlfeiler, Piperato and Associates, LLC, Miami Beach

33311

Broward General Medical Center, Fort Lauderdale

33316

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

33614

St. Joseph's Hospital d/b/a Comprehensive Research Institute, Tampa

34695

AHF Health Positive - Tampa Bay, Safety Harbor

34982

Midway Immunology and Research Center, Ft. Pierce

35294

University of Alabama at Birmingham, Birmingham

44093

Chu Hotel Dieu, Nantes

44203

Summa Health System Care Center, Akron

45122

Department of Dermatology University Hospital Essen, Essen

48072

Be Well Medical Center, Berkley

48202

Henry Ford Health System, Detroit

53105

Medizinische Universitätsklinik I der Friedrich-Wilhelms Universität Bonn, Bonn

53226

Medical College of Wisconsin, Milwaukee

55415

Hennepin County Medical Center, Minneapolis

59208

Centre Hospitalier de Tourcoing, Tourcoing

60311

Private Practice Gute & Locher & Lutz, Infektiologikum, Frankfurt am Main

60611

Northwestern University, Chicago

60613

Howard Brown Health Center, Chicago

60657

Northstar Medical Center, Chicago

63108

Central West Clinical Research, Inc., St Louis

63139

Southampton Healthcare, St Louis

69288

Hôpital de la Croix-Rousse, Lyon

75018

Hopital Bichat Claude Bernard, Paris

75208

Trinity Health and Wellness Center, Dallas

75219

Southwest Infectious Disease Associates, Inc., Dallas

75475

HOSPITAL SAINT LOUIS - Services des Maladies Infectieuses, Paris

75571

Hopital Saint Antoine- Service Maladies infectieuses, Paris

75605

DCOL Center for Clinical Research, Longview

75651

Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses, Paris

75970

Hopital Tenon Service des Maladies infectieuses et tropicales, Paris

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts, P.A., Houston

77098

Gordon E. Crofoot MD PA, Houston

78550

Garcia Family Health Group, Harlingen

78705

Central Texas Clinical Research, Austin

79106

Division of Infectious Disease, Department of Medicine, University Hospital Freiburg, Freiburg im Breisgau

80209

Apex Research LLC, Denver

80335

MUC Research GmbH, München

85012

Spectrum Medical Group, Phoenix

87505

Southwest Care Center, Sante Fe

90027

Kaiser Permanente Medical Center, Los Angeles

90028

Jeffrey Goodman Special Care Clinic/Los Angeles Gay and Lesbian Center, Los Angeles

90036

Lightsource Medical, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

90059

Oasis Clinic, Los Angeles

90069

Anthony Mills MD Inc, Los Angeles

90211

AHF Research Center, Beverly Hills

90813

Living Hope Education and Research Consultants, Long Beach

92103

La Playa Medical Group and Clinical Research, San Diego

92380

Hopital Raymond Poincare, Garches

92663

Orange Coast Medical Group, Newport Beach

94114

Metropolis Medical/Dr.Fritz, San Francisco

94118

Kaiser Permanente Medical Center, San Francisco, San Francisco

94304

Stanford University, Palo Alto

94545

Kaiser Permanente Medical Center, Hayward

94609

East Bay AIDS Center, Oakland

95817

University of California, Davis, Sacramento

95825

Kaiser Permanente Medical Group, Sacramento

96813

Clint Spencer Clinic, Honolulu

98104

Peter Shalit, M.D., Seattle

99204

Rockwood Pulmonary and Critical Care, Spokane

02111

Community Research Initiative of New England, Boston

01105

Claudia T Martorell, MD., LLC dba The Research Institute, Springfield

07102

Saint Michael's Medical Center, Newark

08244

South Jersey Infectious Disease, Somers Point

02010

Holdsworth House Medical Practice, Darlinghurst

St Vincent's Hospital, Sydney, Darlinghurst

Taylor Square Private Clinic, Darlinghurst

Albion Street Centre, Surry Hills

East Sydney Doctors, Sydney

03068

Northside Clinic, Fitzroy North

03004

Clinical Research - Infectious Diseases Unit Alfred Hospital, Melbourne

03181

Prahran Market Clinic, Prahran

A-8020

LKH Medical University Graz West, Department of Internal Medicine, Graz

A6020

Universitätsklinikum Innsbruck Universitätsklinik für Dermatologie und Venerologie, Innsbruck

01090

Department of Dermatology, Allergy, and Infectious Disease University Vienna Medical School, Vienna

01200

Cliniques Universitaires Saint-Luc - UCL, Brussels

03000

University Hospitals Leuven, Leuven

V6Z 1Y6

Division of HIV/AIDS, St. Paul's Hospital, Vancouver

V6Z2C7

Vancouver ID Research and Care Centre Society, Vancouver

K1H 8L6

The Ottawa Hospital, General Campus, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 1K2

Maple Leaf Research Maple Leaf Medical Clinic, Toronto

M5G 2N2

University Health Network/Toronto General Hospital, Toronto

H2L 4P9

Clinique médicale L' Actuel, Montreal

H2X 2P4

McGill University Health Center, Montreal Chest Institute, Montreal

06200

CHU Nice - Archet 1, Nice

00149

"National Institute for Infectious Diseases L. Spallanzani IRCCS", Rome

1091 AC

Onze Lieve Vrouwe Gasthuis, Amsterdam

PB 2040

Erasmus MC, Rotterdam

1649-035

Hospital de Santa Maria - CHLN, EPE, Lisbon

4200-319

Serviço de Doenças Infecciosas, Hospital S. Joao, Porto

4369-004

Hospital de Joaquim urbano, Porto

00909

Clinical Research Puerto Rico, San Juan

03010

Hospital General Universitario Alicante, Alicante

Universitätsklinik für Infektiologie, Bern

08907

Hospital Universitari de Bellvitge, Cataluña

03202

Hospital Universitario de Elche, Unidad de Enfermedades Infecciosas, Elche

01011

CHUV, Lausanne

08091

University Hospital Zurich, Zurich

BN2 5BE

Royal Sussex County Hospital, Brighton

EH42XU

Ridu, Wgh, Edinburgh

E11 BB

Clinical Research, Grahame Hayton Unit Ambrose King Centre, The Royal London Hospital, London

NW32QG

Royal Free NHS Trust,, London

SE7 4EH

Guys and St Thomas' NHS trust, London

Sw10 9NH

Chelsea and Westminster Hospital, London

M8 5RB

North Manchester General Hospital, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY