Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

PHASE3CompletedINTERVENTIONAL
Enrollment

482

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

January 31, 2012

Study Completion Date

October 31, 2014

Conditions
HIV-1 Infection
Interventions
DRUG

FTC/RPV/TDF

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

DRUG

PI

Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir. PIs were administered according to prescribing information.

DRUG

RTV

Ritonavir (RTV) was administered according to prescribing information.

DRUG

NRTIs

NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF, Truvada® (emtricitabine/tenofovir DF, coformulated), and zidovudine. NRTIs were administered according to prescribing information.

Trial Locations (111)

1000

CHU Saint-Pierre University Hospital, Brussels

9000

Universitaire Ziekenhuis Gent, Ghent

10003

Beth Israel Medical Center, New York

10016

The Aaron Diamond AIDS Research Center, New York

12157

EPIMED GmbH, Berlin

19104

University of Pennsylvania, Philadelphia

19107

Philadelphia FIGHT, Philadelphia

20036

Capital Medical Associates PC, Washington D.C.

20127

Fondazione Centro San Raffaele del Monte Tabor, Milan

20142

Azienda Ospedaliera San Paolo, Mallattie Infettive e Tropicali, Milan

20146

ICH Study Center Hamburg, Hamburg

20149

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

20157

Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive, Milan

21093

Johns Hopkins University School of Medicine, Lutherville

22003

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

24128

Ospedali Riuniti, Bergamo

27157

Wake Forest University Health Sciences, Winston-Salem

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Ramon y Cajal, Madrid

28036

Hospital Clinic i Provincial, Barcelona

28078

Rosedale Infectious Diseases, Huntersville

28209

ID Consultant, P.A., Charlotte

28916

Hospital Germans Trias i Pujol, Barcelona

29203

University of South Carolina, Columbia

30033

Infectious Disease Specialists of Atlanta (IDSA), Decatur

30308

AIDS Research Consortium of Atlanta, Atlanta

30309

Atlanta ID Group, Atlanta

32504

Wade, Barbara Private Practice, Pensacola

32803

Orlando Immunology Center, Orlando

32806

ValueHealthMD, LLC/IDOCF, Orlando

33062

University of South Florida - HIV Clinical Research Unit, Tampa

33133

The Kinder Medical Group, Miami

33139

Wohlfeiler, Piperato and Associates, LLC, Miami Beach

33316

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

33614

St. Joseph's Comprehensive Research Institute, Tampa

34695

Barry M. Rodwick, M.D., Safety Harbor

34982

Midway Immunology & Research Center, Ft. Pierce

35294

University of Alabama - Birmingham, Birmingham

48072

Be Well Medical Center, Berkley

50937

University of Cologne, Department of Internal Medicine, Cologne

53127

University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic, Bonn

55415

Hennepin County Medical Center, Minneapolis

60596

Infectio Research, Frankfurt

60611

Northwestern University Feinberg School of Medicine, Chicago

60612

The Ruth M. Rothstein CORE Center, Chicago

60657

Northstar Medical Center, Chicago

63139

Southampton Healthcare, Inc., St Louis

69002

Hôpital Hôtel-Dieu, Lyon

72207

Health for Life Clinic, PLLC, Little Rock

75010

Department of Infectious Diseases, Saint-Louis hospital, Paris

75012

Hôpital Saint Antoine, Servuce de Maladies Infectieuses, Paris

75018

Bichat Hospital, Paris

75204

Nicholaos Bellos, MD, PA, Dallas

75605

DCOL Center for Clinical Research, Longview

76104

Tarrant County Infectious Diseases Associates, Fort Worth

77004

Therapeutic Concepts, P.A., Houston

77098

Gordon E. Crofoot, MD, PA, Houston

Research Access Network, Houston

78550

Garcia Family Medical Clinic, Harlingen

85012

Spectrum Medical Group, Phoenix

90019

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

90027

Kaiser Permanente, Los Angeles

90028

Jeffrey Goodman Special Care Clinic, Los Angeles

90059

Oasis Clinic, Los Angeles

90069

Anthony Mills, MD Internal Medicine, Los Angeles

90211

AIDS Healthcare Foundation-Research Center, Beverly Hills

90813

The Living Hope Foundation, Long Beach

92103

La Playa Medical Group and Clinical Research, San Diego

92626

Center for Special Immunology, Costa Mesa

92663

Orange Coast Medical Group, Newport Beach

94115

Metropolis Medical, San Francisco

94118

Kaiser Permanente, San Francisco

94303

Stanford University, Palo Alto

94545

Kaiser Permanente, Hayward

94602

Alameda County Medical Center, Oakland

94609

East Bay AIDS Center, Oakland

95187

University of California, Davis, Sacramento

95825

Kaiser Permanente, Sacramento

Unknown

Pacific Oaks Medical Group, Beverly Hills

Care Resource, Miami

Kansas City Free Health Clinic, Kansas City

Greiger Clinic, Mount Vernon

Univ.-Kklinik fuer Innere Medizin III, Salzberg

LKH Graz West, Styria

2.Interne Lungenabteilung Otto Wagner Spital, Vienna

Dept. of Dermatology, Div. of Immunology,, Vienna

Private Office, Vienna

University Hospitals Leuven, Flemish Brabant

Downtown Infectious Disease Clinic - Univ of BC, Vancouver

Maple Leaf Research, Toronto

Sunnybrook Health Sciences Centre, Toronto

Winnipeg Regional Health Authority, Winnipeg

Infectiologie - 7ème Ouest - CHU HOTEL DIEU, Nantes

Hopital Tenon, Paris

Maladies Infectieuses Dpt, Paris

Hôpital Haut Levêque, Pessac

Center for HIV and Hepatogastroenterology, Düsseldorf

University Medical Center Hamburg - Eppendorf, Hamburg

Homerton Unversity Hospital, London

02115

Brigham & Women's Hospital, Boston

01105

The Research Institute, Springfield

07102

Saint Michael's Medical Center, Newark

08244

South Jersey Infectious Disease, Somer Point

H2L 5B1

Clinique Medicale Du Quartier Latin, Montreal

06202

Archet 1 CHU de Nice - 6ème Niveau - Infectiology, Nice

00909

Clinical Research Puerto Rico, Inc., San Juan

BN2 1ES

Brighton and Sussex University Hospitals NHS Trust, Brighton

E1 1BB

Barts and the London NHS Trust, London

NW3 2QG

Royal Free Hospital, London

SW10 9NH

Chelsea and Westminster Hospital Foundation Trust, London

M85RB

North Manchester General Hospital, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY