719
Participants
Start Date
July 21, 2016
Primary Completion Date
March 29, 2018
Study Completion Date
August 15, 2022
Dolutegravir (DTG)
DTG is available as 50 mg white, round, biconvex, film coated tablet debossed on one side with 'SV 572' and on the other side with '50'. The tablets are packaged into high density polyethylene (HDPE) bottles with induction seals and child resistant closures. Each 45 ml bottle contains 30 tablets and a desiccant. DTG 50 mg tablet will be orally administered once daily with or without food upto 148 weeks.
Lamivudine (3TC)
Lamivudine is available as swedish orange, 'AA' sized elongated double blind HPMC capsules containing 300 mg lamivudine to visually match overencapsulated TDF/FTC FDC tablet. The capsules are packaged into HDPE bottles with induction seals and child resistant closures. Each 150 mL bottle contains 30 capsules and a desiccant. Overencapsulated 3TC 300 mg tablet will be orally administered once daily with or without food upto 96 weeks. From Week 96 to Week 148, lamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets debossed with 'GX CJ7' on both sides, packed in over labelled HDPE bottles with child-resistant closures each containing 30 tablets.
Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
Tenofovir disoproxil fumarate and Emtricitabine are available as swedish orange, 'AA' sized elongated double blind HPMC capsules containing 300 mg TDF and 200 mg FTC to visually match overencapsulated 3TC tablet. The capsules are packaged into HDPE bottles with induction seals and child resistant closures. Each 150 mL bottle contains 30 capsules and a desiccant. Overencapsulated tenofovir disoproxil fumarate/emtricitabine tablet will be orally administered once daily with or without food upto 96 weeks. From Week 96 to Week 148, tenofovir disoproxil fumarate/emtricitabine will be dispensed as 300/200 mg white, blue, capsule shaped, film coated tablets debossed with 'GILEAD' on one side and '701' on another side, packed in overlabelled HDPE bottles with polypropylene childresistant closures each containing 30 tablets and a desiccant.
GSK Investigational Site, Taipei
GSK Investigational Site, Kaohsiung City
GSK Investigational Site, Brussels
GSK Investigational Site, Brussels
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Brussels
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Antwerp
GSK Investigational Site, Darlinghurst
GSK Investigational Site, Sydney
GSK Investigational Site, Fortitude Valley
GSK Investigational Site, Observatory, Cape Town
GSK Investigational Site, Berlin
GSK Investigational Site, Taipei
GSK Investigational Site, Marseille
GSK Investigational Site, Córdoba
GSK Investigational Site, Santiago de Compostela
GSK Investigational Site, Genoa
GSK Investigational Site, Allentown
GSK Investigational Site, Washington D.C.
GSK Investigational Site, Donostia / San Sebastian
GSK Investigational Site, Milan
GSK Investigational Site, Hamburg
GSK Investigational Site, Busto Arsizio (VA)
GSK Investigational Site, Brescia
GSK Investigational Site, Pavia
GSK Investigational Site, Madrid
GSK Investigational Site, Madrid
GSK Investigational Site, Madrid
GSK Investigational Site, Madrid
GSK Investigational Site, Decatur
GSK Investigational Site, Toulouse
GSK Investigational Site, Orlando
GSK Investigational Site, West Palm Beach
GSK Investigational Site, Ft. Pierce
GSK Investigational Site, Padua
GSK Investigational Site, Vigo
GSK Investigational Site, Bologna
GSK Investigational Site, Daegu
GSK Investigational Site, Reggio Emilia
GSK Investigational Site, Ferrara
GSK Investigational Site, Guadalajara
GSK Investigational Site, Essen
GSK Investigational Site, Zapopan
GSK Investigational Site, Valencia
GSK Investigational Site, Indianapolis
GSK Investigational Site, Berkley
GSK Investigational Site, Busan
GSK Investigational Site, Bonn
GSK Investigational Site, St Louis
GSK Investigational Site, Kansas City
GSK Investigational Site, Paris
GSK Investigational Site, Paris
GSK Investigational Site, Paris
GSK Investigational Site, Bellaire
GSK Investigational Site, Munich
GSK Investigational Site, Phoenix
GSK Investigational Site, Le Kremlin-Bicêtre
GSK Investigational Site, Moscow
GSK Investigational Site, Saint Petersburg
GSK Investigational Site, Oryol
GSK Investigational Site, Cluj-Napoca
GSK Investigational Site, Toliyatti
GSK Investigational Site, Yekaterinburg
GSK Investigational Site, Красноярск
GSK Investigational Site, Galati
GSK Investigational Site, Springfield
GSK Investigational Site, Chapel Hill
GSK Investigational Site, Providence
GSK Investigational Site, Ciudad Autonoma de Buenos Aires
GSK Investigational Site, Ciudad Autónoma de Buenos Aires
GSK Investigational Site, Ottawa
GSK Investigational Site, Montreal
GSK Investigational Site, Montreal
GSK Investigational Site, Roma
GSK Investigational Site, Distrito Federal
GSK Investigational Site, Rotterdam
GSK Investigational Site, Rotterdam
GSK Investigational Site, Coimbra
GSK Investigational Site, Lisbon
GSK Investigational Site, Porto
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Alicante
GSK Investigational Site, Badalona
GSK Investigational Site, Elche (Alicante)
GSK Investigational Site, Mataró
GSK Investigational Site, London
GSK Investigational Site, London
GSK Investigational Site, Manchester
Lead Sponsor
Collaborators (2)
PPD Development, LP
INDUSTRY
GlaxoSmithKline
INDUSTRY
ViiV Healthcare
INDUSTRY