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

PHASE3CompletedINTERVENTIONAL
Enrollment

872

Participants

Timeline

Start Date

December 26, 2012

Primary Completion Date

August 26, 2014

Study Completion Date

September 6, 2017

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)

1000

CHU Saint-Pierre University Hospital, Brussels

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

1070

Hôpital Erasme-ULB, Anderlecht

1090

DIAID, Department of Dermatology, Medical University Vienna, Vienna

1140

Otto-Wagner-Spital, Sozialmedizinisches Zentrum Baumgartner Hoehe, Vienna

2010

Holdsworth House Medical Practice, Darlinghurst

Taylor Square Private Clinic, Darlington

Albion Street Centre, Sydney

3010

Universitätsspital Bern, Bern

3053

Melbourne Sexual Health Clinic, Carlton

10029

Mount Sinai School of Medicine, New York

10330

The HIV Netherland Australia Thailand, Thai Red Cross AIDS Research Center (The HIV-NAT), Bangkok

10400

Ramathibodi Hospital, Mahidol University, Bangkok

10461

Jacobi Medical Center, The Bronx

10467

Montefiore Medical Center, The Bronx

10700

Siriraj Hospital, Bangkok

11000

Bamrasnaradura Infectious Diseases Institute, Nonthaburi

11030

North Shore University Hospital - Division of Infectious Diseases, Manhasset

11355

New York Hospital Queens, Flushing

12208

Albany Medical College, Albany

Upstate Infectious Diseases Associates, Albany

15706

Complejo Hospitalario Universitario de Santiago (CHUS), Santiago de Compostela

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

20009

Dupont Circle Physicians Group, P.C., Washington D.C.

Whitman Walker Clinic, Washington D.C.

20036

Capital Medical Associates, P.C., Washington D.C.

20127

Ospedale San Raffaele, Milan

21201

Institute of Human Virology, University of Maryland, Baltimore

22003

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

22710

Duke University, Durham

27514

University of North Carolina, Chapel Hill

28007

Hospital General Universitario Gregorio Maranon, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28078

Rosedale Infectious Diseases, Huntersville

28209

Infectious Disease Consultants, PA, Charlotte

29203

University of South Carolina School of Medicine, Columbia

29425

Medical University of South Carolina, Charleston

30033

Infectious Disease Specialist of Atlanta, Decatur

30308

AIDS Research Consortium of Atlanta, Atlanta

Emory University, Atlanta

30309

Atlanta ID Group, PC, Atlanta

31201

Mercer University School of Medicine, Macon

32504

Infectious Diseases Associates, Pensacola

32803

Orlando Immunology Center, Orlando

32806

IDOCF/ValuHealthMD, LLC, Orlando

32960

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

33133

The Kinder Medical Group, Miami

33139

AIDS Healthcare Foundation, Miami Beach

33316

Gary Richmond, MD, PA, Inc., Fort Lauderdale

33602

The University of South Florida, Tampa

33614

Infectious Disease Research Institute Inc., Tampa

St. Joseph's Comprenhensive Research Inisitute, Tampa

34982

Midway Immunology & Research Center, LLC, Ft. Pierce

35294

The University of Alabama at Birmingham, Birmingham

40002

Khon Kaen University, Khon Kaen

44304

Summa Health Care Center, Akron

48072

Be Well Medical Center, Berkley

48202

Henry Ford Hospital, Detroit

50200

Chiang Mai University, Chiang Mai

53226

Medical College of Wisconsin, Milwaukee

55415

Hennepin County Medical Center, Minneapolis

60611

Northwestern University, Chicago

60612

Ruth M. Rothstein CORE Center, Chicago

60613

Howard Brown Health Center, Chicago

63108

Central West Clinical Research, Inc., St Louis

63139

Southampton Healthcare, Inc., St Louis

75208

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

75246

North Texas Infectious Diseases Consultants, Dallas

75605

DCOL Center for Clinical Research, Longview

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts, PA, Houston

77098

Gordon E. Crofoot, MD, PA, Houston

77401

St. Hope Foundation, Inc., Bellaire

78550

Garcias' Family Health Group, Harlingen

78705

Central Texas Clinical Research, Austin

80209

Apex Research, LLC, Denver

85012

Spectrum Medical Group, Phoenix

87505

Southwest C.A.R.E. Center, Santa Fe

90027

Kaiser Permanente Los Angeles, Los Angeles

90035

University of California, Los Angeles, Los Angeles

90036

Peter J. Ruane, MD, Inc., Los Angeles

90069

Anthony Mills MD Inc, Los Angeles

90502

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

92103

La Playa Medical Group and Clinical Research, San Diego

University of California, San Diego, San Diego

94609

East Bay AIDS Center, Oakland

95825

Kaiser Permanente - Sacramento, Sacramento

96816

University of Hawaii - Hawaii Center for AIDS, Honolulu

98104

Peter Shalit, MD, Seattle

06510

Yale University School of Medicine, New Haven

02111

Community Research Initative, Boston

02115

Brigham & Women's Hospital, Boston

01702

Metrowest Medical Center, Framingham

01199

Baystate Infectious Diseases Clinical Research, Springfield

08844

ID Care, Hillsborough

07102

Saint Michael's Medical Center, Newark

02906

The Miriam Hospital, Providence

2010 NSW

East Sydney Doctors, Sydney

V6Z 2T1

Spectrum Health, Vancouver

R3A 1R9

Health Sciences Centre Winnipeg, Winnipeg

K1H 8L6

The Ottawa Hospital, Ottawa

M5G 1K2

Maple Leaf Research, Toronto

H2L 5B1

Clinique Medicale Du Quartier Latin, Montreal

Clinique medicale l'Actuel, Montreal

H3A 1T1

Clinique OPUS, Montreal

M4N 3M5

Sunnybrook Health Science Center, Toronto

162-8655

National Center for Global Health and Medicine AIDS Clinical Center, Shinjuku-ku, Tokyo

00909

HOPE Clinical Research, San Juan

08916

Hospital Germans Trias i Pujol, Badalona

08003

Hospital del Mar, Barcelona

08035

Hospital Universitari Vall D'Hebron, Barcelona

08036

Hospital Clinic i Provincial, Barcelona

08907

University Hospital Bellvitge, Barcelona

CH-8091

University Hospital, Zurich, Zurich

SW10 9TH

Chelsea & Westminster Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01780506 - Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults | Biotech Hunter | Biotech Hunter