167
Participants
Start Date
December 22, 2015
Primary Completion Date
February 21, 2018
Study Completion Date
March 21, 2018
E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
TDF
300 mg tablet administered orally once daily
FTC
200 mg capsule administered orally once daily
FTC/TDF
200/300 mg tablet administered orally once daily
3TC
Tablet administered orally
Third agent
"Third agent may include one of the following regimens: lopinavir+ritonavir (LPV/r; Kaletra®), atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®), ATV + cobicistat (COBI;Tybost®) (or ATV/COBI FDC), DRV + RTV, darunavir (DRV; Prezista®) + COBI (or DRV/COBI FDC), fosamprenavir (FPV; Lexiva®) + RTV , saquinavir (SQV; Invirase®; Fortovase®) + RTV, efavirenz (EFV;Sustiva®), rilpivirine (RPV;Edurant®), nevirapine (NVP;Viramune®), etravirine (ETR;Intelence®), raltegravir (RAL; Isentress®), elvitegravir (EVG) + COBI, or dolutegravir (DTG;Tivicay®)~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"
CHU Saint-Pierre University Hospital, Brussels
University Hospital Gent, Ghent
CHU - Groupe Saint-Andre, Bordeaux
CHU de Dijon, Dijon
Hopital Europeen Marseille, Marseille
C.H.U. de Nantes, Nantes
C.H.U. de NICE, Nice
CHU Hotel Dieu, Paris
Hopital Necker les Enfants Malades, Paris
Hopital Saint Antoine, Paris
Hopital Saint Louis, Paris
Hopital Haut-Leveque, Pessac
Service des Maladies Infectieuses et du Voyageur, Tourcoing
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo
Busto Arsizio Hospital, Busto Arsizio
IRCCS A.O.U. San Martino, Genova
Azienda Ospedaliera Luigi Sacco, Milan
Azienda Ospedaliero Universitaria Policlinico di Modena, Modena
U.O. Malattie Infettive, Pescara
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S., Roma
Azienda Ospedaliero Universitaria di Sassari, Sassari
Dipartimento di Malattie Infettive e Tropicali, Torino
Hospital Clinic de Barcelona, Barcelona
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Universitari Germans Trias i Pujol, Barcelona
Hospital Vall d'Hebron, Barcelona
Hospital 12 de Octubre, Madrid
Hospital General Universitario Gregorio Maranon, Madrid
Hospital Universitario La Paz, Madrid
Ramon Y Cajal University Hospital, Madrid
Hospital Costa Del Sol, Marbella
Hospital General Universitario de Valencia, Valencia
Royal Victoria Hospital, Belfast
Mortimer Market Centre, London
Newcastle Royal Victoria Infirmary, Newcastle upon Tyne
Lead Sponsor
Gilead Sciences
INDUSTRY