722
Participants
Start Date
July 18, 2016
Primary Completion Date
April 4, 2018
Study Completion Date
June 29, 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, Lima
GSK Investigational Site, New Taipei City
GSK Investigational Site, Taoyuan District
GSK Investigational Site, Tainan City
GSK Investigational Site, Kaohsiung City
GSK Investigational Site, Kaohsiung City
GSK Investigational Site, Brussels
GSK Investigational Site, Darlinghurst
GSK Investigational Site, Parramatta
GSK Investigational Site, Bern
GSK Investigational Site, Fitzroy North
GSK Investigational Site, Prahran
GSK Investigational Site, Córdoba
GSK Investigational Site, Lodelinsart
GSK Investigational Site, Zurich
GSK Investigational Site, Ghent
GSK Investigational Site, Turin
GSK Investigational Site, Taipei
GSK Investigational Site, México
GSK Investigational Site, Genoa
GSK Investigational Site, Granada
GSK Investigational Site, Washington D.C.
GSK Investigational Site, Hamburg
GSK Investigational Site, Milan
GSK Investigational Site, Milan
GSK Investigational Site, Milan
GSK Investigational Site, Monza
GSK Investigational Site, Bergamo
GSK Investigational Site, Madrid
GSK Investigational Site, Marid
GSK Investigational Site, Madrid
GSK Investigational Site, Madrid
GSK Investigational Site, Alcorcón
GSK Investigational Site, Málaga
GSK Investigational Site, Decatur
GSK Investigational Site, Bucharest
GSK Investigational Site, Savannah
GSK Investigational Site, Orlando
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, West Palm Beach
GSK Investigational Site, Ft. Pierce
GSK Investigational Site, Seville
GSK Investigational Site, Modena
GSK Investigational Site, Guadalajara
GSK Investigational Site, Valencia
GSK Investigational Site, Valencia
GSK Investigational Site, Berkley
GSK Investigational Site, Cologne
GSK Investigational Site, Bonn
GSK Investigational Site, Frankfurt am Main
GSK Investigational Site, Chicago
GSK Investigational Site, St Louis
GSK Investigational Site, Lyon
GSK Investigational Site, Dallas
GSK Investigational Site, Paris
GSK Investigational Site, Fort Worth
GSK Investigational Site, Houston
GSK Investigational Site, Houston
GSK Investigational Site, Austin
GSK Investigational Site, Aurora
GSK Investigational Site, München
GSK Investigational Site, Los Angeles
GSK Investigational Site, Bobigny
GSK Investigational Site, San Francisco
GSK Investigational Site, San Leandro
GSK Investigational Site, Sacramento
GSK Investigational Site, St.Peterburg
GSK Investigational Site, Saint Petersburg
GSK Investigational Site, Krasnodar
GSK Investigational Site, Kazan'
GSK Investigational Site, Izhevsk
GSK Investigational Site, Kemerovo
GSK Investigational Site, Iași
GSK Investigational Site, Birmingham
GSK Investigational Site, Hillsborough
GSK Investigational Site, Newark
GSK Investigational Site, Cincinnati
GSK Investigational Site, Rosario
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Melbourne
GSK Investigational Site, Vancouver
GSK Investigational Site, Toronto
GSK Investigational Site, Montreal
GSK Investigational Site, Distrito Federal
GSK Investigational Site, Lima
GSK Investigational Site, Lima
GSK Investigational Site, Bydgoszcz
GSK Investigational Site, Amadora
GSK Investigational Site, Lisbon
GSK Investigational Site, Porto
GSK Investigational Site, Bucharest
GSK Investigational Site, Barcelona
GSK Investigational Site, Barcelona
GSK Investigational Site, Barcelona
GSK Investigational Site, Geneva
GSK Investigational Site, Woolwich, London
GSK Investigational Site, Brighton
GSK Investigational Site, Liverpool
GSK Investigational Site, London
GSK Investigational Site, London
GSK Investigational Site, London
GSK Investigational Site, Manchester
Lead Sponsor
Collaborators (1)
GlaxoSmithKline
INDUSTRY
ViiV Healthcare
INDUSTRY