Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

September 3, 2013

Primary Completion Date

July 21, 2015

Study Completion Date

July 9, 2016

Conditions
HIV-1HIV InfectionsAcquired Immunodeficiency Syndrome
Interventions
DRUG

E/C/F/TAF

150/150/200/10 mg FDC tablet administered orally once daily

DRUG

DRV

800 mg tablet administered orally once daily

DRUG

Baseline DRV- containing ARV regimen

Participants will take their baseline DRV- containing ARV regimen as prescribed.

Trial Locations (62)

10003

Beth Israel Medical Center, New York

10011

Weill Medical College, New York

11355

New York Hospital Queens, Flushing

12208

Albany Medical College, Albany

14642

University of Rochester, Rochester

19104

University Of Pennsylvania, Philadelphia

19107

Philadelphia FIGHT, Philadelphia

Thomas Jefferson University, Philadelphia

20009

Dupont Circle Physician's Group, Washington D.C.

21093

Johns Hopkins University, Lutherville

27157

Wake Forest University Health Sciences, Winston-Salem

27710

Duke University Health System, Durham

27858

East Carolina University The Brody School of Medicine, Infectious Diseases, Greenville

28207

Carolinas Medical Center--Myer's Park, Charlotte

30309

Atlanta ID Group, Atlanta

30312

AIDS Research Consortium of Atlanta, Atlanta

31201

Mercer University, Mercer Medicine, Macon

32504

Infectious Diseases Associates of NW FL, Pensacola

32720

Midland Florida Clinical Research Center, LLC, DeLand

32803

Orlando Immunology Center, Orlando

32806

Valuhealthmd/Idocf, Orlando

32960

AIDS Research and Treatment Center of the Treasure Coast, Vero Beach

33308

Therafirst Medical Center, Fort Lauderdale

33316

Gary J.Richmond, MD, P.A., Fort Lauderdale

33401

Triple O Research Institute PA, West Palm Beach

33602

Hillsborough County Health Department, Tampa

33614

St. Joseph's Comprehensive Research Institute, Tampa

34982

Midway Immunology and Research Center, Ft. Pierce

43210

The Ohio State University Medical Center, Columbus

44304

Summa Health System CARE Center, Akron

48202

Henry Ford Health System, Detroit

55404

Abbott Northwestern Hospital, Minneapolis

60612

The Ruth M. Rothstein CORE Center, Chicago

60613

Howard Brown Health Center, Chicago

63108

Central West Clinical Research, St Louis

64111

The Kansas City Free Health Clinic/ KC Care Clinic, Kansas City

75246

North Texas infectious Diseases Consultants, PA, Dallas

75606

DCOL Center for Clinical Research, Longview

77004

Therapeutic Concepts, PA, Houston

77098

Gordon E. Crofoot MD PA, Houston

84102

University of Utah, Salt Lake City

85015

Pueblo Family Physicians, Ltd., Phoenix

87505

Southwest CARE Center, Santa Fe

90036

Peter J Ruane, MD, Inc., Los Angeles

90211

Pacific Oaks Medical Group, Beverly Hills

90813

Long Beach Education and Research Consultants, Long Beach

94118

Kaiser San Francisco Division of Research, San Francisco

94545

Kaiser Permanente, Hayward

95825

Kaiser Permanente Medical Group, Sacramento

98104

Peter Shalit, MD, Seattle

220003

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

02115

Brigham and Women's Hospital, Boston

02215

Harvard Medical School, Boston

01199

Baystate Infectious Diseases Clinical Research, Springfield

08244

South Jersey Infectious Disease, Somers Point

02906

The Miriam Hospital, Providence

T2R 0X7

Southern Alberta Clinic, Calgary

V6Z2C7

Vancouver ID Research & Care Centre Society, Vancouver

R3A 1R9

Wrha - Health Sciences Centre Winnipeg, Winnipeg

K1H 8L6

Ottawa Hospital - General Campus, Ottawa

M5G1K2

Maple Leaf Research, Toronto

H2l 4P9

Clinique médicale L'actuel, Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY