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

PHASE3CompletedINTERVENTIONAL
Enrollment

707

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

August 31, 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

Atripla

Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime

DRUG

Stribild Placebo

Placebo to match Stribild STR administered orally once daily

DRUG

Atripla Placebo

Placebo to match Atripla tablet administered orally once daily prior to bedtime

Trial Locations (102)

10003

Beth Israel Medical Center, New York

10011

Chelsea Village Medical, PC, New York

Ricky K. Hsu, MD, PC, New York

10016

The Aaron Diamond AIDS Research Center, New York

10467

Montefiore Medical Center - AIDS Center, The Bronx

10550

Greiger Clinic, Mount Vernon

11030

North Shore University Hospital, Manhasset

11203

SUNY Downstate Medical Center, Brooklyn

11355

New York Hospital Queens, Flushing

12208

Upstate ID Association, Albany

19104

University of Pennsylvania, Philadelphia

19107

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.

21205

Johns Hopkins University School of Medicine, Baltimore

22003

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

27157

Wake Forest University Health Sciences, Winston-Salem

27599

Clinical and Translational Research Center, Chapel Hill

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

30033

Infectious Disease Specialists of Atlanta, Decatur

30308

AIDS Research Consortium of Atlanta, Atlanta

Emory University, Atlanta

30309

Atlanta ID Group, PC, Atlanta

31210

Mercer University School of Medicine, Macon

Jacobi Medical Center, The Bronx

32803

Orlando Immunology Center, Orlando

32806

Idocf/ Valuhealthmd, Llc, Orlando

32960

Treasure Coast Infectious Disease Consultants, Vero Beach

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

33316

Gary J. Richmond, MD, PA, 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

34982

Midway Immunology and Research Center, Ft. Pierce

35294

University of Alabama at Birmingham, Birmingham

44304

Summa Health System, Akron

48072

Be Well Medical Center, Berkley

48202

Henry Ford Health System, Detroit

53226

Medical College of Wisconsin, Milwaukee

55415

Hennepin County Medical Center, Minneapolis

60612

Ruth M. Rothstein CORE Center, Chicago

60613

Howard Brown Health Center, Chicago

63108

Central West Clinical Research, St Louis

63139

Southampton Healthcare, St Louis

72207

Health for Life Clinic PLLC, Little Rock

75204

Southwest Infectious Disease Clinical Research, Inc., Dallas

75215

Peabody Health Center, Dallas

75605

DCOL Center for Clinical Research, Longview

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts, Houston

77098

Gordon E. Crofoot MD PA, Houston

Research Access Network, Houston

78550

Valley AIDS Council, Harlingen

80209

Apex Research, LLC, Denver

85012

Spectrum Medical Group, Phoenix

87505

SouthWest CARE Center, Sante Fe

90027

Kaiser Permanente, Los Angeles

90028

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

90035

UCLA Center for Clinical Aids Research and Education, 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

92663

Orange Coast Medical Group, Newport Beach

94110

San Francisco General Hospital, University of California, San Francisco, San Francisco

94115

Metropolis 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

95825

Kaiser Permanente Medical Group, Sacramento

96816

Leahi Hospital, Honolulu

98104

Peter Shalit, MD, Seattle

99204

Rockwood Pulmonary and Critical Care, Spokane

06033

Yale University HIV Clinical Trials Program, New Haven

06902

The Stamford Hospital, Stamford

02115

Brigham & Women's Hospital, Boston

02215

Community Research Initiative, Boston

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

00731

Instituto de Investigacion Clentifica del Sur, Ponce

00909

Clinical Research Puerto Rico, San Juan

HOPE Clinical Research, San Juan

00921

VA Caribbean Healthcare System, San Juan

00935

University of Puerto Rico, School of Medicine, Proyecto ACTU, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY