Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

275

Participants

Timeline

Start Date

November 18, 2015

Primary Completion Date

June 14, 2017

Study Completion Date

January 24, 2018

Conditions
HIV-1 Infection
Interventions
DRUG

E/C/F/TAF

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

DRUG

ABC/3TC

600/300 mg tablets administered orally once daily

DRUG

Third Antiretroviral Agent

"Third antiretroviral agents could include one of the following:~* ATV+cobicistat (COBI; Tybost®) or ATV/COBI FDC~* DRV+COBI or DRV/COBI FDC~* darunavir (DRV; Prezista®) + RTV~* lopinavir/ritonavir (LPV/r; Kaletra®)~* atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®)~* efavirenz (EFV; Sustiva®)~* etravirine (ETR; Intelence®)~* nevirapine (NVP; Viramune®)~* rilpivirine (RPV; Edurant®)~* dolutegravir (DTG; Tivicay®)~* raltegravir (RAL; Isentress®)~* fosamprenavir (FPV; Lexiva®) + RTV~* saquinavir (SQV; Invirase®) + RTV~* ATV (no booster)~Drug classes:~* Protease inhibitors (PI): LPV/r, ATV, RTV, ATV, DRV, FPV and SQV~* Pharmacokinetic enhancer: COBI~* Non-nucleoside reverse transcriptase inhibitors (NNRTI): EFV, RPV, NVP, and ETR~* Integrase inhibitors: RAL and DTG"

Trial Locations (49)

75208

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

76104

Tarrant County ID Associates, Fort Worth

78705

Central Texas Clinical Research, Austin

90036

Ruane Clinical Research Group, Los Angeles

Unknown

Spectrum Medical Group, Phoenix

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

Georgetown University, Washington D.C.

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

Midway Immunology & Research Center, LLC, Ft. Pierce

Steinhart Medical Associates dba The Kinder Medical Group, Miami

Triple O Research Institute PA, West Palm Beach

The Positive Health Clinic, Allegheny Health Network, Pittsburgh

CHU - Groupe Saint-Andre, Bordeaux

Hopital Henri Mondor, Créteil

Hopital Europeen Marseille, Marseille

C.H.U. de Nantes, Nantes

C.H.U. de NICE, Nice

CHU Hotel Dieu, Paris

Hopital Lariboisiere, Paris

Hopital Necker les Enfants Malades, Paris

Hopital Saint Antoine, Paris

Hopital Saint Louis, Paris

Centre Hospitalier Gustave Dron, Tourcoing

Epimed GmbH, Berlin

Universitatsklinikum Essen, Essen

ICH Study Center Hamburg, Hamburg

Universitatsklinikum Hamburg-Eppendorf, Hamburg

ARNAS Garibaldi - Nesima, Catania

Unit Infectious Diseases - University of Catania - ARNAS Garibaldi, Catania

Azienda Ospedaliera Luigi Sacco, Milan

Azienda Ospedaliero Universitaria Policlinico di Modena, Modena

Azienda Ospedale San Paolo, Monza

Azienda Ospedaliera San Gerardo, Monza

Ospedale Civile S. Spirito AUSL, Pescara

Unità Operativa Complessa di Malattie Infettive, Pescara

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

Comprensorio Ospedaliero Amedeo di Savoia, Torino

Dipartimento di Malattie Infettive e Tropicali, Torino

Hospital Clinic de Barcelona, Barcelona

Hospital de la Santa Creu i Sant Pau, Barcelona

Hospital Universitari Vall d'Hebron, Barcelona

Hospital General Universitario Gregorio Maranon, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital Costa Del Sol, Marbella

Hospital Reg. Univ. Carlos Haya, Málaga

Hospital Clínico Universitario de Valencia (Galindo), Valencia

Hospital General Universitario de Valencia (Abril), Valencia

Hospital Alvaro Cunqueiro, Vigo

Mortimer Market Centre, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY