Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

PHASE3CompletedINTERVENTIONAL
Enrollment

632

Participants

Timeline

Start Date

January 26, 2015

Primary Completion Date

June 22, 2016

Study Completion Date

January 9, 2019

Conditions
HIV-1 Infection
Interventions
DRUG

FTC/RPV/TAF

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

DRUG

FTC/RPV/TDF Placebo

Tablets administered orally once daily

DRUG

FTC/RPV/TDF

200/25/300 mg FDC tablets administered orally once daily

DRUG

FTC/RPV/TAF Placebo

Tablets administered orally once daily

Trial Locations (117)

10029

Icahn School of Medicine at Mount Sinai, New York

10439

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

Unknown

The University of Alabama at Birmingham (UAB), Birmingham

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

Alameda County Medical Center, Oakland

Desert Medical Group Inc., dba Desert Oasis Healthcare Medical Group, Palm Springs

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.

Dupont Circle Physicians Group, Washington D.C.

Medical Faculty Associates, 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

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

Chatham County Health Department, Savannah

Indiana University Medical Center, Indianapolis

Brigham and Women's, Boston

Community Research Initiative, 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

Jersey Shore Medical Center, Neptune City

Saint Michael's Medical Center, Newark

South Jersey Infectious Disease, Somers Point

Southwest CARE Center, Santa Fe

Upstate Infectious Diseases Associates, Albany

Montefiore Medical Center, The Bronx

University of North Carolina at Chapel Hill, Chapel Hill

Carolinas Medical Center--Myers Park Infectious Disease Clinic, Charlotte

Rosedale Infectious Diseases, Huntersville

University of Pennsylvania, Philadelphia

Medical University of South Carolina, Charleston

Central Texas Clinical Research, Austin

North Texas Infectious Diseases Consultants, 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

Medical College of Wisconsin, Milwaukee

CHU Saint-Pierre University Hospital, Brussels

Cliniques Universitaires UCL Saint-Luc, Brussels

University Hospital Gent, Ghent

University of Alberta, Edmonton

Spectrum Health, Vancouver

Maple Leaf Research, Toronto

University Health Network, Toronto

Clinique medicale l'Actuel, Montreal

Clinique OPUS, Montreal

McGill University Health Centre, Montreal

Hôpital Gui de Chauliac - Service Maladies Infectieuses et Tropicales, Montpellier

University of Bonn, Bonn

Universitat zu Koln, Cologne

Center for HIV and Hepatogastroenterology, Düsseldorf

Universitätsklinikum Essen, Essen

Infektiologikum, Frankfurt

Asklepios Klinik, Hamburg

ICH Study Center Hamburg, Hamburg

Universitatsklinikum Hamburg-Eppendorf, Hamburg

MUC Research GmbH, München

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

Fondazione IRCCS San Raffaele del Monte Tabor, Milan

Erasmus MC, Rotterdam

Clinical Research Puerto Rico Inc, San Juan

Hope Clinical Research, San Juan

Hospital General Universitario de Alicante, Alicante

Hospital Germans Trias i Pujol, Badalona

Hospital del Mar, Barcelona

Hospital Universitary de Bellvitge, Barcelona

Hospital Clínico Universitario San Carlos, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario La Paz, Madrid

Karolinska Institutet, Stockholm

University Hospital Basel, Basel

Geneva University Hospital, Geneva

NHS Greater Glasgow, Glasgow

Barts & The London NHS Trust, London

Chelsea & Westminster Hospital, London

Mortimer Market Centre, London

The Royal Free Hampstead NHS Trust, London

The Hathersage Integrated Contraception, Sexual Health and HIV Service, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY