618
Participants
Start Date
October 28, 2016
Primary Completion Date
May 29, 2018
Study Completion Date
December 31, 2025
Cabotegravir (CAB) tablet
It is a white oval shaped film coated 30 mg tablets for oral administration. CAB Tablet is composed of cabotegravir sodium, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, and white film-coat
Rilpivirine (RPV) tablet
"It is a 25 mg tablet with off-white, round, biconvex, film-coated and debossed on one side with TMC and the other side with 25. Each tablet contains RPV hydrochloride, and the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose"
Cabotegravir - Injectable Suspension (CAB LA)
It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection
Rilpivirine - Injectable Suspension (RPV LA)
It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.
2 NRTIs plus an INI, NNRTI, or PI
"Acceptable stable (initial or second) ARV regimens include 2 NRTIs plus:~* INI with the exception of ABC/DTG/3TC (either the initial or second cART regimen)~* NNRTI (either the initial or second cART regimen)~* Boosted PI (or atazanavir \[ATV\] unboosted) (either the initial or second PI-based cART regimen)"
GSK Investigational Site, Middelburg
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Rosario
GSK Investigational Site, Darlinghurst
GSK Investigational Site, Sydney
GSK Investigational Site, Johannesburg
GSK Investigational Site, Prahran
GSK Investigational Site, Durban
GSK Investigational Site, Durban
GSK Investigational Site, Cape Town
GSK Investigational Site, Bloemfontein
GSK Investigational Site, Winnie Mandela
GSK Investigational Site, New York
GSK Investigational Site, New York
GSK Investigational Site, Berlin
GSK Investigational Site, Berlin
GSK Investigational Site, Córdoba
GSK Investigational Site, Buffalo
GSK Investigational Site, Pittsburgh
GSK Investigational Site, Santiago de Compostela
GSK Investigational Site, Allentown
GSK Investigational Site, Washington D.C.
GSK Investigational Site, Washington D.C.
GSK Investigational Site, Washington D.C.
GSK Investigational Site, Hamburg
GSK Investigational Site, Milan
GSK Investigational Site, Hamburg
GSK Investigational Site, Annandale
GSK Investigational Site, Lynchburg
GSK Investigational Site, Brescia
GSK Investigational Site, Madrid
GSK Investigational Site, Madrid
GSK Investigational Site, Madrid
GSK Investigational Site, Charlotte
GSK Investigational Site, Málaga
GSK Investigational Site, Hanover
GSK Investigational Site, Toulouse
GSK Investigational Site, Macon
GSK Investigational Site, Vero Beach
GSK Investigational Site, Fort Lauderdale
GSK Investigational Site, Sarasota
GSK Investigational Site, Montpellier
GSK Investigational Site, Ft. Pierce
GSK Investigational Site, Daejeon
GSK Investigational Site, Birmingham
GSK Investigational Site, Vigo Pontevedra
GSK Investigational Site, Seville
GSK Investigational Site, Daegu
GSK Investigational Site, Guadalajara
GSK Investigational Site, Essen
GSK Investigational Site, Valencia
GSK Investigational Site, Detroit
GSK Investigational Site, Pusan
GSK Investigational Site, Bonn
GSK Investigational Site, Tourcoing
GSK Investigational Site, Frankfurt
GSK Investigational Site, Frankfurt
GSK Investigational Site, Chicago
GSK Investigational Site, St Louis
GSK Investigational Site, Omaha
GSK Investigational Site, Paris
GSK Investigational Site, Dallas
GSK Investigational Site, Paris
GSK Investigational Site, Paris
GSK Investigational Site, Paris
GSK Investigational Site, Houston
GSK Investigational Site, Austin
GSK Investigational Site, Denver
GSK Investigational Site, München
GSK Investigational Site, Phoenix
GSK Investigational Site, Los Angeles
GSK Investigational Site, Los Angeles
GSK Investigational Site, Long Beach
GSK Investigational Site, Palm Springs
GSK Investigational Site, Saint-Denis
GSK Investigational Site, Bakersfield
GSK Investigational Site, San Francisco
GSK Investigational Site, San Francisco
GSK Investigational Site, Moscow
GSK Investigational Site, Saint Petersburg
GSK Investigational Site, Saint Petersburg
GSK Investigational Site, Saint Petersburg
GSK Investigational Site, Smolensk
GSK Investigational Site, Oryol
GSK Investigational Site, Krasnodar
GSK Investigational Site, Lipetsk
GSK Investigational Site, Saratov
GSK Investigational Site, Kazan'
GSK Investigational Site, Toliyatti
GSK Investigational Site, Yekaterinburg
GSK Investigational Site, Kemerovo
GSK Investigational Site, Boston
GSK Investigational Site, Chapel Hill
GSK Investigational Site, Cincinnati
GSK Investigational Site, Ciudad Autonoma de Bueno
GSK Investigational Site, Ottawa
GSK Investigational Site, Toronto
GSK Investigational Site, Montreal
GSK Investigational Site, Montreal
GSK Investigational Site, Québec
GSK Investigational Site, Regina
GSK Investigational Site, Pretorai
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Badalona
GSK Investigational Site, Barcelona
GSK Investigational Site, Barcelona
GSK Investigational Site, Barcelona
GSK Investigational Site, Elche Alicante
GSK Investigational Site, Gothenburg
GSK Investigational Site, Stockholm
GSK Investigational Site, Stockholm
Lead Sponsor
Collaborators (2)
Janssen Pharmaceuticals
INDUSTRY
GlaxoSmithKline
INDUSTRY
ViiV Healthcare
INDUSTRY