Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

708

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2014

Conditions
HIVHIV Infections
Interventions
DRUG

Stribild

Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily

DRUG

ATV

Atazanavir 300 mg capsule administered orally once daily

DRUG

Ritonavir

Ritonavir (RTV; /r) 100 mg tablet administered orally once daily

DRUG

FTC/TDF

FTC/TDF 200/300 mg tablet administered orally once daily

DRUG

Stribild Placebo

Placebo to match Stribild administered orally once daily

DRUG

ATV Placebo

Placebo to match ATV administered orally once daily

DRUG

RTV Placebo

Placebo to match RTV administered orally once daily

DRUG

FTC/TDF Placebo

Placebo to match FTC/TDF administered orally once daily

Trial Locations (146)

1000

CHU Saint-Pierre University Hospital, Brussels

1011

CHUV, Lausanne

1070

Hôpital Universitaire Erasme - ULB, Brussels

1090

Department of Dermatology, Division of Immunology, Allergy & Inf. Diseases; Medical University Vienna, Vienna

1140

Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital, Vienna

2000

Epidemiklinikken 5112, Rigshospitalet, Copenhagen

2010

Holdsworth House Medical practice, Darlinghurst

National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales, Darlinghurst

Albion Street Centre, Sydney

East Sydney Doctors, Sydney

3004

Alfred Hospital, Melbourne

3053

Melbourne Health - Royal Melbourne Hospital Campus (Sexual Health Clinic), Carlton

3068

Northside Clinic, Melbourne

9000

University of Ghent, Ghent

10003

Beth Israel Medical Center, New York

10011

Chelsea Village Medical, PC, New York

10149

Dipartimento di Malattie Infettive, Torino

10400

Ramathibodi Hospital, Mahidol University, Bangkok

10467

Montiefiore Medical Center- AIDS Center, The Bronx

10550

Greiger Clinic, Mount Vernon

10700

Siriraj Hospital, Bangkok

11030

North Shore University Hospital, Manhasset

11203

STAR Health Care Center (SUNY Downstate), Brooklyn

11883

Venhälsan, Södersjukhuset, Stockholm

12208

Upstate ID Association, Albany

12209

Albany Medical College, Albany

14033

Service des Maladies Infectieuses, CHU de Caen, Caen

14604

AIDS Care, Rochester

19107

Division of Infectious Diseases, Thomas Jefferson University, Philadelphia

Philadelphia FIGHT, 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

20246

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

22003

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

27157

Wake Forest University Health Sciences, Winston-Salem

27710

Duke University Medical Center, Durham

27834

East Carolina University, Greenville

28078

Rosedale Infectious Diseases, Huntersville

28207

Carolinas Medical Center-Myers Park, Charlotte

29203

University of South Carolina, Columbia

30308

AIDS Research Consortium of Atlanta, Atlanta

30309

Infectious Disease Solutions, PC, Atlanta

31210

Mercer University School of Medicine, Macon

32803

Orlando Immunology Center, Orlando

32806

IDOCF/ ValueHealthMD, LLC, Orlando

32960

Treasure Coast Infectious Disease Consultants, Vero Beach

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

34295

CHU Gui de Chauliac, Maladies Infectieuses Dpt, Montpellier

34982

Midway Immunology and Research Center, Ft. Pierce

40237

Center for HIV and Hepatogastroenterology, Düsseldorf

44093

CHU de Nantes Hopital de l'Hotel Dieu, Nantes

44280

Unidad de VIH, 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

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

59208

Centre Hospitalier de Tourcoing, Tourcoing

60311

Infektio Research GmbH / Infektiologikum Frankfurt, Frankfurt am Main

60590

Klinikum der Goethe-Universitaet, Medizinische Klinik II, Schwerpunkt HIV, Haus 68, Frankfurt am Main

60612

Ruth M. Rothstein CORE Center, Chicago

60613

Howard Brown Health Center, Chicago

63108

CentralWest Clinical Research, St Louis

63110

Division of Infectious Diseases, St. Louis University Medical Center, St Louis

63139

Southampton Healthcare, St Louis

69317

Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales, Lyon

72207

Health for Life Clinic PLLC, Little Rock

75010

Department of Infectious Diseases, Saint-Louis hospital, Paris

75012

Hopital Saint Antoine, Service De Maladies Infectieuses, Paris

75018

Bichat Hospital, Paris

75020

Tenon Hospital, UPMC, Paris

75204

Nicholaos C. Bellos, MD, PA (Southwest Infectious Disease Clinical Research, Inc.), Dallas

75208

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

75605

DCOL Center for Clinical Research, Longview

75651

Hopital Pitie-Salpetriere, Paris

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Dr. Joseph C. Gathe MD (Therapeutic Concepts, PA), Houston

77098

Gordon E. Crofoot MD PA, Houston

Research Access Network, Houston

78550

Garcia's Family Health Group, Harlingen

80206

National Jewish Health, Denver

80209

Apex Research, LLC, Denver

80335

MUC Research GmbH, München

85012

Spectrum Medical Group, Phoenix

90027

Kaiser Permanente, Los Angeles

90028

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

90036

Peter J Ruane, MD, Inc, Los Angeles

90048

Cedars-Sinai Medical Center, 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

CSI Clinical Trials, Inc., Costa Mesa

92663

Orange Coast Medical Group, Newport Beach

94115

Metropolitan Medical, San Francisco

94118

Kaiser Permanente Medical Center, Clinical Trials Unit, San Francisco

94303

Stanford University, Palo Alto

94545

Kaiser Permanente Hospital, Hayward

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

Leahi Hospital, Honolulu

98104

Peter Shalit, M.D., Seattle

06033

Yale University HIV Clinical Trials Program, New Haven

06902

The Stamford Hospital, Stamford

01107

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

08043

Garden State Infectious Diseases Associates, PA, Voorhees Township

N.S.W. 2011

Taylor Square Private Clinica, Darlinghurst

A-8010

LKH Graz West, Graz

T2R0X7

Southern Alberta Clinic, Calgary

R3A 1R9

Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg, Winnipeg

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5B1L6

Canadian Immunodeficiency Research Collaborative (CIRC) Inc., 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

06200

Centre Hospitalier Universitaire de Nice, Nice

00149

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

Unknown

Onze lieve vrouw gasthuis, Amsterdam

3000 CA

Erasmus MC, Internal Medicine, Section of Infectious Diseases, Rotterdam

4202-451

Serviço de Doenças Infecciosas, Hospital de São João, Porto

00909

Clinical Research Puerto Rico, San Juan

00921

VA Caribbean Healthcare System, San Juan

BN2 1ES

Brighton and Sussex University Hospitals NHS Trust, Brighton

M8 5RB

North Manchester General Hospital, Manchester

E1 1BB

Barts and the London NHS Trust, London

E9 6SR

Homerton University Hospital, London

SW10 9NH

Chelsea and Westminster Hospital Foundation Trust, London

W2 1NY

St. Mary's Hospital, London (Imperial College, London), London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY