Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

438

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

December 31, 2014

Conditions
Acquired Immunodeficiency SyndromeHIV Infections
Interventions
DRUG

PI

PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)

DRUG

RTV

RTV administered according to prescribing information FTC/TDF administered according to prescribing information

DRUG

FTC/TDF

FTC/TDF (200/300 mg) administered according to prescribing information

DRUG

Stribild

Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

Trial Locations (99)

1090

Medical University of Vienna, Vienna

1140

Otto-Wagner-Spital, Vienna

1205

Geneva University Hospital, Geneva

2755

HHP Hospital de Cascais, Alcabideche

4000

CHU Sart Tilman, Liège

5020

Univ.-Kklinik fuer Innere Medizin III, Salzburg

8091

University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology, Zurich

9000

University Hospital Ghent, Ghent

10122

University of Torino, Dept of Infectious Disease, Torino

10550

Greiger Clinic, Mount Vernon

12157

Epimed GmbH, Berlin

19104

University of Pennsylvania, Philadelphia

19107

Philadelphia FIGHT, Philadelphia

20009

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

20036

Capital Medical Associates, PC, Washington D.C.

20127

Fondazione Centro San Raffaele, Milan

20142

Clinic of Infectious Diseases, University of Milan-San Paolo Hospital, Milan

20146

ICH Study Center, Hamburg

20157

Ospedale Luigi Sacco, Milan

20246

Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie, Hamburg

24128

Ospedali Riuniti, Bergamo

25030

CHU de Besancon, Hopital Saint-Jacques, Besançon

27157

Wake Forest University Health Sciences, Winston-Salem

28029

Infectious Diseases Department, Hospital Carlos III, Madrid

28034

Hospital Ramon y Cajal, Madrid

28209

ID Consultants, P.A., Charlotte

28760

Hospital La Paz, Madrid

30309

Atlanta ID Group, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

32504

Infectious Diseases Associates of NW FL, P.A., Pensacola

32803

Orlando Immunology Center, Orlando

32806

Idocf/Valuhealthmd, Llc, Orlando

33133

The Kinder Medical Group, Miami

33316

Gary Richmond, MD, Fort Lauderdale

33604

Hôpital Haut Lévêque, Pessac

33614

St. Joseph's Comprehensive Research Institute, Tampa

34295

CHU Hôpital Gui de Chauliac, Montpellier

34695

AHF Health Positive Tampa Bay, Safety Harbor

34982

Midway Immunology & Research Center, LLC, Ft. Pierce

41013

Hospital Virgen del Rocio, Seville

45147

Universitätsklinikum Essen, Dermatologie, HIV Ambulanz, Essen

48072

Be Well Medical Center, Berkley

50937

Infektlonsambulanz Unlkllnik Koln, Cologne

53127

University of Bonn, Bonn

55415

Hennepin County Medical Center, Minneapolis

60590

Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68, Frankfurt

60611

Northwestern University Division of Infectious Diseases, Chicago

60612

John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center, Chicago

64111

The Kansas City Free Health Clinic, Kansas City

69317

Hôpital de la Croix-Rousse, Lyon

75010

Saint-Louis Hospital, Paris

75012

Hopital Saint Antoine, Paris

75018

Hôpital Bichat-Claude Bernard, Paris

75020

hôpital Tenon, Paris

75204

Uptown Physicians Group, Dallas

75219

Southwest Infectious Disease Clinical Research, Inc, Dallas

75651

Maladies Infectieuses Dpt, Paris

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts, PA, Houston

77098

Gordon Crofoot Md, Pa, Houston

77401

St. Hope Foundation Inc, Houston

80336

Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen, Munich

85012

Spectrum Medical Group, Phoenix

85015

Pueblo Family Physicians, Phoenix

90027

Kaiser Permanente, Los Angeles

90036

Peter J. Ruane, M.D., Inc., Los Angeles

90043

OASIS Clinic, Los Angeles

90069

Anthony Mills MD Inc, Los Angeles

90211

AIDS Healthcare Foundation, Beverly Hills

Pacific Oaks Medical Group, Beverly Hills

92103

La Playa Medical Group and Clinical Research, San Diego

94109

Metropolis Medical, San Francisco

94118

Kaiser Permanente San Francisco, San Francisco

94304

Stanford University, Palo Alto

94545

Kaiser Permanente, Hayward

95817

University of California, Davis, Sacramento

95841

Kaiser Permanente, Sacramento

08844

I.D. Care Associates PA, Hillsborough

07102

Saint Michael's Medical Center, Newark

08244

South Jersey Infectious Disease, Somers Point

A 6020

Innsbruck Medical University, Innsbruck

01200

UCL Saint Luc, Brussels

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

H2L 5B1

Clinique Medicale Du Quartier Latin, Montreal

06202

Archet 1 Chu Nice Department of Infectology, Nice

00149

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

1049-035

Hospital de Santa Maria-CHLN, EPE, Lisbon

1150-069

Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa, Lisbon

00909

Clinical Research Puert Rico, San Juan

00935

University of Puerto Rico School of Medicine, San Juan

03010

Hospital General Universitario Alicante, Alicante

08036

Hospital clinic, Barcelona

08907

Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service., Barcelona

08916

Hospital Germans Trias I Pujol, Barcelona

03202

Hospital General Universitario de Elche, Elche, Alicante

CH-8038

Zentrum fur Infektionskrankheiten, Zurich

BN21ES

Brighton and Sussex University Hospitals NHS Trust, Brighton

NW32QG

Royal Free Hampstead NHS Trust, London

SW109NH

Chelsea and Westminster, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY