Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

881

Participants

Timeline

Start Date

January 26, 2015

Primary Completion Date

June 29, 2016

Study Completion Date

January 2, 2019

Conditions
HIV-1 Infection
Interventions
DRUG

FTC/RPV/TAF

200/25/25 mg FDC tablets administered orally once daily

DRUG

EFV/FTC/TDF Placebo

Tablets administered orally once daily

DRUG

EFV/FTC/TDF

600/200/300 mg FDC tablets administered orally once daily

DRUG

FTC/RPV/TAF Placebo

Tablets administered orally once daily

Trial Locations (117)

85004

Maricopa Integrated Health System, Phoenix

Unknown

Spectrum Medical Group, Phoenix

AHF Research Center, Beverly Hills

Pacific Oaks Medical Group, Beverly Hills

Long Beach Education and Research Consultants, Long Beach

Kaiser Permanente, Los Angeles

Southern California Men's Medical Group, Los Angeles

Tarrant County ID Associates, Los Angeles

Kaiser Permanente, Sacramento

University of California-UC Davis, Sacramento

La Playa Medical Group and Clinical Research, San Diego

Kaiser Permanente, San Francisco

Optimus Medical, San Francisco

Kaiser Permanente, San Leandro

Los Angeles BioMedical Institute at Harbor-UCLA Medical Center, Torrance

University of Colorado, Aurora

Apex Research Institute, Denver

Yale University School of Medicine, New Haven

World Health Clinicians' CIRCLE CARE Center, Norwalk

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

Medical Faculty Associates, Inc., Washington D.C.

Whitman Walker Clinic, Washington D.C.

Gary Richmond, MD, PA, Inc., Fort Lauderdale

Therafirst Medical Centers, Fort Lauderdale

Midway Immunology & Research Center, LLC, Ft. Pierce

AIDS Healthcare Foundation, Miami

University of Miami, Miami

AIDS Healthcare Foundation, Miami Beach

Orlando Immunology Center, Orlando

Infectious Diseases Associates of NW Florida, P.A., Pensacola

Hillsborough County Health Dept., Tampa

Infectious Disease Research Institute Inc., Tampa

St. Joseph's Comprehensive Research Institute, Tampa

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

Triple O Research Institute, P.A., West Palm Beach

Rowan Tree Medical PA, Wilton Manors

AIDS Research Consortium of Atlanta, Atlanta

Atlanta ID Group, Atlanta

Infectious Disease Specialists of Atlanta, Decatur

Mercer University School of Medicine, Macon

Chatham County Health Department, Savannah

The CORE Foundation, Chicago

Indiana University Medical Center, Indianapolis

Boston University Medical Center, Boston

Brigham and Women's, Boston

MetroWest Medical Center, Framingham

Baystate Infectious Diseases Clinical Research, Springfield

The Research Institute, Springfield

Be Well Medical Center, Berkley

Henry Ford Health System, Detroit

Hennepin County Medical Center, Minneapolis

Southampton Healthcare, Inc., St Louis

Saint Michael's Medical Center, Newark

South Jersey Infectious Disease, Somers Point

Southwest CARE Center, Santa Fe

Upstate Infectious Diseases Associates, Albany

North Shore University Hospital, Manhasset

Columbia University Medical Center/ New York Presbyterian, New York

Jacobi Medical Center, The Bronx

Montefiore Medical Center, The Bronx

University of North Carolina at Chapel Hill, Chapel Hill

Infectious Disease Consultants, PA, Charlotte

The Brody School of Medicine, Greenville

Rosedale Infectious Diseases, Huntersville

The Ohio State University, Columbus

University of Pennsylvania, Philadelphia

The Miriam Hospital, Providence

Medical University of South Carolina, Charleston

Central Texas Clinical Research, Austin

North Texas Infectious Diseases Consultants, Dallas

Southwest Infectious Disease Clinical Research, Inc., Dallas

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

AIDS Arms, Inc./Trinity Health & Wellness Center, Fort Worth

Gordon E. Crofoot, MD, PA, Houston

Research Access Network, Houston

DCOL Center for Clinical Research, Longview

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

Peter Shalit, MD, Seattle

Premier Clinical Research, Spokane

CHU Saint-Pierre University Hospital, Brussels

Cliniques Universitaires UCL Saint-Luc, Brussels

University of Alberta, Edmonton

Spectrum Health, Vancouver

Health Sciences Centre, Winnipeg

Maple Leaf Research, Toronto

University Health Network, Toronto

Clinique medicale l'Actuel, Montreal

Clinique OPUS, Montreal

McGill University Health Centre, Montreal

Hopital Bichat Claude Bernard, Paris

Hopital Saint Louis, Paris

Chu Tours, Tours

Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH (zibp), Berlin

University of Bonn, Bonn

Universitat zu Koln, Cologne

Center for HIV and Hepatogastroenterology, Düsseldorf

Universitätsklinikum Essen, Essen

Infektiologikum, Frankfurt

ICH Study Center Hamburg, Hamburg

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

MUC Research GmbH, München

Clinical Research Puerto Rico Inc, San Juan

Hope Clinical Research, San Juan

University of Puerto Rico School of Medicine, San Juan

Hospital General Universitario de Alicante, Alicante

Hospital Clinic i Provincial, Barcelona

Hospital del Mar, Barcelona

Hospital Universitary de Bellvitge, Barcelona

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario La Paz, Madrid

University Hospital Basel, Basel

Geneva University Hospital, Geneva

Centre Hospitalier Universitaire Vaudois, Lausanne

Barts & The London NHS Trust, London

King's College Hospital, London

Mortimer Market Centre, London

The Royal Free Hampstead NHS Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT02345226 - Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults | Biotech Hunter | Biotech Hunter