Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

439

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

December 31, 2014

Conditions
Acquired Immunodeficiency SyndromeHIV Infections
Interventions
DRUG

NNRTI

NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.

DRUG

FTC/TDF

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

DRUG

Stribild

Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

Trial Locations (80)

1050

Hôpitaux IRIS Sud, Brussels

1090

Medical University of Vienna, Vienna

1140

Otto Wagner Spital, Vienna

1214

Policlinico Universitario Agostino Gemelli, Rome

2000

SEAMEO Regional Centre for Tropical Medicine, Antwerp

3000

University Hospital of Leuven, Leuven

8003

Hospital del Mar, Barcelona

10016

Aaron Diamond AIDS Research Center, New York

10550

Greiger Clinic, Mount Vernon

12157

EPIMED GmbH, Berlin

13353

MIB Dienstleistung GmbH, Berlin

15706

Hospital Clinico Universitario de Santiago, Santiago de Compostela

19107

Philadelphia FIGHT, Philadelphia

20009

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

20036

Capital Medical Associates, P.C., Washington D.C.

20127

Fondazione Centro San Raffaele del Monte Tabor, Milan

20146

ICH Study Center, Hamburg

20157

Ospedale Luigi Sacco, Milan

21052

Azienda Ospedaliera Ospedale di Circolo Busto Arsizio, Busto Arsizio/Varese

22003

Clinical Alliance for Research & Education - Infectious Disease, Annandale

25030

CHU de Besancon - Hopital Saint-Jacques, Besançon

27157

Wake Forest University Health Sciences, Winston-Salem

28007

Hospital General Universitario Gregorio Maranon, Madrid

28209

ID Consultants, P.A., Charlotte

30033

Infectious Disease Specialists of Atlanta, Decatur

30309

Atlanta ID Group, PC, Atlanta

32504

Infectious Diseases Associates of Northwest Florida, Pensacola

32803

Orlando Immunology Center, Orlando

32806

ValuHealth MD, LLC, Orlando

33079

Groupe Hospitalier Pellegrin, Bordeaux

33133

The Kinder Medical Group, Miami

33316

Gary Richmond MD, PA, Inc, Fort Lauderdale

34684

Health Positive, Safety Harbor

34982

Midway Immunology and Research, Ft. Pierce

46009

Hospital La Fe de Valencia, Valencia

48072

Be Well Medical Center, Berkley

53127

Medizinische Universitätsklinik, Bonn

55415

HIV Program Hennepin County Medical Center, Minneapolis

60596

Infektiologikum, Frankfurt

64111

The Kansas City Free Health Clinic, Kansas City

75010

Hopital Saint Louis, Paris

75018

Hopital Bichat Claude Bernard, Paris

75219

Southwest Infectious Disease Clinical Researach Inc, Dallas

75571

Hopital Saint Antoine, Paris

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts PA, Houston

77098

Gordon E. Crofoot MD, PA, Houston

79106

Universitatsklinikum Freiburg, Freiburg im Breisgau

80335

MUC Research GmbH, München

85012

Spectrum Medical Group, Phoenix

90036

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

90059

OASIS Clinic, Los Angeles

90069

Anthony Mills MD Inc, Los Angeles

90211

AHF Research Center, Beverly Hills

Pacific Oak Medical Group, Beverly Hills

92103

La Playa Medical Group and Clinical Research, San Diego

94109

Metropolis Medical, San Francisco

94118

Kaiser Permanente, San Francisco

94545

Kaiser Permanente, Hayward

94602

Alameda County Medical Center, Oakland

95825

Kaiser Permanente Medical Group, Sacramento

08844

ID Care, Hillsborough

07102

Saint Michael's Medical Center, Newark

08244

South Jersey Infectious Disease, Somers Point

NSW 2010

Holdsworth House Medical Practice, Darlinghurst

East Sydney Doctors, Sydney

VIC 3141

Prahran Market Clinic, South Yarra

M4N 3M5

Sunnybrook Health Sciences Center, Toronto

M5B1L6

Maple Leaf Medical Clinic, Toronto

H2L 5B1

Clinique Medicale Du Quartier Latin, Montreal

00149

"Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS", Roma

1649-035

Hospital de Santa Maria - CHLN EPE, Lisbon

00909

Clinical Research Puerto Rico Inc, San Juan

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

BN2 1ES

Brighton and Sussex University Hospitals NHS Trust, Brighton

EH4 2XU

Western General Hospital, Edinburgh

E9 6SR

Homerton University Hospital, London

SE1 1EE

South London Healthcare NHS Trust, London

SE17EH

St. Thomas' Hospital, London

SW10 9TH

Chelsea & Westminster Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01495702 - Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients | Biotech Hunter | Biotech Hunter