Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

698

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

November 30, 2011

Study Completion Date

April 30, 2015

Conditions
HIVHIV Infections
Interventions
DRUG

COBI

Cobicistat (COBI) 150 mg tablet administered orally once daily

DRUG

RTV

Ritonavir (RTV) 100 mg tablet administered orally once daily

DRUG

ATV

Atazanavir (ATV) 300 mg capsule administered orally once daily

DRUG

FTC/TDF

Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily

DRUG

COBI placebo

Placebo to match COBI administered orally once daily

DRUG

RTV placebo

Placebo to match RTV administered orally once daily

Trial Locations (134)

1000

CHU Saint-Pierre University Hospital, Brussels

1011

CHUV, Lausanne

1070

Hôpital Universitaire Erasme - ULB, Brussels

1090

Allgemeines Krankenhaus, Vienna

1140

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

2000

Rigshospitalet, Infektionsklinik 5112, Copenhagen

2010

St Vincent's Hospital, Sydney, Darlinghurst

Taylor Square Private Clinic, Darlinghurst

Albion Street Centre, Sydney

Holdsworth House Medical practice, Sydney

3004

Alfred Hospital, Melbourne

3010

Universitätsklinik für Infektiologie, Universitätsspital Bern, Bern

3053

Melbourne Sexual Health Centre, Carlton

3068

Northside Clinic, Melbourne

8091

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

9000

University of Ghent, Ghent

10011

Chelsea Village Medical, PC, New York

Mt Sinai School of Medicine, New York

Ricky K. Hsu, MD, PC, New York

10149

Dipartimento di Malattie Infettive, Torino

10330

HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University, Bangkok

10400

Ramathibodi Hospital, Mahidol University, Bangkok

10467

Montefiore Medical Center - AIDS Center, The Bronx

10700

Siriraj Hospital, Bangkok

11030

North Shore University Hospital, Manhasset

12157

EPIMED GmbH, Berlin

13009

Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH, Marseille

14033

Service des Maladies Infectieuses, CHU de Caen, Caen

19104

University of Pennsylvania, Philadelphia

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.

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

20157

Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive, Milan

20246

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

21205

Johns Hopkins University School of Medicine, Baltimore

27157

Wake Forest University Health Sciences, Winston-Salem

27710

Duke University Medical Center, Durham

27834

East Carolina University, The Brody School of Medicine, Greenville

28007

Hospital General Universitario Gregorio Marañon, Madrid

28078

Rosedale Infectious Diseases, Huntersville

28207

Carolinas Medical Center-Myers Park, Charlotte

29203

University of South Carolina, Columbia

30033

Infectious Disease Specialists of Atlanta, Decatur

31210

Mercer University School of Medicine, Macon

32803

Orlando Immunology Center, Orlando

32806

Idocf/ Valuhealthmd, Llc, Orlando

33133

The Kinder Medical Group, Miami

33136

University of Miami School of Medicine, Miami

33139

Wohlfeiler, Piperato and Associates, LLC, Miami Beach

33308

Therafirst Medical Center, Fort Lauderdale

33311

Broward Health/Comprehensive Care Center, Fort Lauderdale

33602

University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department, Tampa

33604

Centre François Magendie, Hôpital du Haut Lévêque, Pessac

33614

Infectious Disease Research Institute Inc., Tampa

33615

St. Joseph's Comprehensive Research Institute, Tampa

34982

Midway Immunology and Research Center, Ft. Pierce

35294

University of Alabama at Birmingham, Birmingham

40002

Khon Kaen University, Khon Kaen

41013

Hospital Virgen del Rocio, Seville

44093

CHU de Nantes Hopital de l'Hotel Dieu, Nantes

44280

Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde, Guadalajara

48072

Be Well Medical Center, Berkley

48202

Henry Ford Health System, Detroit

50200

Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine, Chiang Mai

50937

University of Cologne, Department of Internal Medicine, Cologne

53127

Medizinische Universitätsklinik, Bonn

53226

Medical College of Wisconsin, Milwaukee

55415

Hennepin County Medical Center, Minneapolis

59208

Centre Hospitalier de Tourcoing, Tourcoing

60311

Infektio Research GmbH / Infektiologikum Frankfurt, Frankfurt am Main

60613

Howard Brown Health Center, Chicago

63108

CentralWest Clinical Research, St Louis

69288

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

Southwest Infectious Disease Clinical Research, Inc., Dallas

75605

DCOL Center for Clinical Research, Longview

75651

Maladies Infectieuses Dpt, Paris

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts, PA, Houston

77098

Gordon E. Crofoot MD PA, Houston

Research Access Network, Houston

78550

Garcia's Family Health Group, Harlingen

80220

Apex Research, LLC, Denver

85012

Spectrum Medical Group, Phoenix

87505

SouthWest CARE Center, Santa Fe

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

90059

Oasis Clinic, Los Angeles

90069

Anthony Mills MD Inc, Los Angeles

90813

Living Hope Clinical Foundation, Long Beach

92103

La Playa Medical Group and Clinical Research, San Diego

94115

Metropolis Medical, San Francisco

94118

Kaiser Permanente Medical Center, Clinical Trials Unit, San Francisco

95817

University of California, Davis Medical Center, Sacramento

95825

Kaiser Permanente Medical Group, Sacramento

98104

Peter Shalit, M.D., Seattle

02215

Community Research Initiative of New England, Boston

07102

Saint Michaels Medical Center, Newark

08244

South Jersey Infectious Disease, Somers Point

A-8010

LKH Graz West, Graz

21040-900

Instituto De Pesquisa Clinica Evandro Chagas, Rio de Janeiro

09060-650

URDIP Faculdade de Medicina do ABC, Santo André

01246-900

Instituto De Infectologia Emilo Ribas, São Paulo

01416-000

Brasilmed Assistencia Medica E Pesquisas, São Paulo

04121-000

Crt-Dst/Aids, São Paulo

13083-970

Universidade Estadual de Campinas, Campinas

R3A 1R9

Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg, Winnipeg

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

H2X 2P4

Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute, Montreal

H3H 1V1

Project LORI, Montreal

Unknown

Instituto Dominicano de Estudios Virologicos - IDEV, Santo Domingo

00149

Istituto Nazionale Malattie Infettive Lazzaro Spallanzani, Roma

1091 AC

Onze lieve vrouw gasthuis, Amsterdam

1649-035

Hospital de Santa Maria - CHLN, Lisbon

4202-451

Serviço de Doenças Infecciosas, Hospital de São João, Porto

00731

Instituto de Investigacion Clentifica del Sur, Ponce

00909

Clinical Research Puerto Rico, San Juan

BN2 1ES

Brighton and Sussex University Hospitals NHS Trust, Brighton

E1 1BB

Barts and the London NHS Trust, London

E9 6SR

Homerton University Hospital, London

SE1 7EH

Guys and St. Thomas' NHS Trust, London

SW17 0QT

Courtyard Clinic, St. Georges Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY