Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC

PHASE3CompletedINTERVENTIONAL
Enrollment

567

Participants

Timeline

Start Date

June 29, 2015

Primary Completion Date

December 11, 2017

Study Completion Date

March 13, 2019

Conditions
HIV-1 Infection
Interventions
DRUG

F/TAF

200/10 mg FDC tablet (with boosted 3rd ARV agents) or 200/25 mg FDC tablet (with unboosted 3rd ARV agents) administered orally once daily

DRUG

ABC/3TC

600/300 mg FDC tablets administered orally once daily

DRUG

ABC/3TC Placebo

Tablets administered orally once daily

DRUG

F/TAF Placebo

Tablets administered orally once daily

DRUG

3rd ARV agent

An allowed 3rd ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP).

Trial Locations (80)

Unknown

Spectrum Medical Group, Phoenix

Pacific Oaks Medical Group, Beverly Hills

University of California San Diego (UCSD), La Jolla

Anthony Mills, MD, Inc., Los Angeles

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

Highland Hospital - Alameda Health System, Oakland

La Playa Medical Group and Clinical Research, San Diego

Capial Medical Associates, Washington D.C.

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

Whitman-Walker Health, Washington D.C.

Gary J. Richmond,M.D.,P.A., Fort Lauderdale

Therafirst Medical Center, Fort Lauderdale

Midway Immunology and Research Center, Ft. Pierce

Orlando Immunology Center, Orlando

Triple O Research Institute PA, West Palm Beach

Atlanta ID Group, Atlanta

Howard Brown Health Center, Chicago

University of Louisville, Louisville

LSU Health Sciences Center, New Orleans

Be Well Medical Center, Berkley

Hennepin County Medical Center, Minneapolis

The KC CARE Clinic, Kansas City

Southampton Healthcare, Inc., St Louis

Saint Michael's Medical Center, Newark

South Jersey Infectious Disease, Somers Point

Southwest CARE Center, Santa Fe

Montefiore Medical Center, The Bronx

Philadelphia FIGHT, Philadelphia

Central Texas Clinical Research, Austin

AIDS Arms, Inc, Dallas

Tarrant County Infectious Disease Associates, Fort Worth

Gordon E. Crofoot MD PA, Houston

Therapeutic Concepts, PA, Houston

Peter Shalit, MD, Seattle

UZ Gent, Ghent

Centre Hospitalier Universitaire CHU Sart Tilman Liege, Liège

Clinique medicale l'Actuel, Montreal

Maple Leaf Research, Toronto

Spectrum Health, Vancouver

Vancouver ID Research and Care Centre Society, Vancouver

Hvidovre Hospital, Copenhagen

CHU - Groupe Saint-Andre, Bordeaux

CHU de Bordeaux, Bordeaux

C.H.U. de Nantes, Nantes

CHR Orleans la Source, Orléans

Chu Tours, Tours

ICH Study Center Hamburg, Bielefeld

Medizinische Universitatsklinik, Bonn

Klinikum der Universitaet Koln, Cologne

Universitatsklinikum Essen, Essen

Johann Wolfgang Goethe-University Hospital, Frankfurt

ifi-Studien und Projekte GmbH an der Asklepiosklinik St. Georg, Hamburg

Universitatsklinikum Hamburg-Eppendorf, Hamburg

Universitätsklinikum München, Munich

Mater Misericordiae University Hospital, Dublin

Saint James's Hospital, Dublin

University of Brescia, Brescia

Azienda Ospedaliera Luigi Sacco, Milan

Fondazione IRCCS San Raffaele del Monte Tabor, Milan

Azienda Ospedaliero Universitaria Policlinico di Modena, Modena

Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S., Roma

Ospedale Amedeo di Savoia - Specializzato Malattie infettive, Torino

Clinical Research Puerto Rico, San Juan

Hope Clinical Research Inc, San Juan

Bonaventura, Badalona

Hospital Universitari de Bellvitge, Barcelona

Hospital Vall d'Hebron, Barcelona

Hospital Clínico Universitario San Carlos, Madrid

Hospital General Universitario Gregorio Maranon, Madrid

Hospital Costa Del Sol, Málaga

Karolinska University Hospital, Stockholm

Birmingham Heartlands Hospital, Birmingham

Barts Health NHS Trust, London

Chelsea and Westminster Hospital, London

Imperial College, London

Kings College Hospital NHS Trust, London

Lewisham and Greenwich NHS Trust, London

Royal Free Hospital, London

St. George's Hospital, London

Manchester Centre for Sexual Health, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY