Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)

PHASE3CompletedINTERVENTIONAL
Enrollment

493

Participants

Timeline

Start Date

November 11, 2019

Primary Completion Date

April 23, 2021

Study Completion Date

September 9, 2022

Conditions
HIV Infections
Interventions
DRUG

DTG/3TC FDC

DTG/3TC FDC will be available as white, oval, film-coated tablets at a unit dose strength of 50 mg/300 mg. Participants will take DTG/3TC once daily via oral route.

DRUG

CAR

Participants who are randomized to the CAR arm will continue to take the current treatment until Week 52. CAR will include 2 NTRIs plus either an INI, NNRTI, or boosted PI or atazanavir unboosted.

Trial Locations (119)

220

GSK Investigational Site, New Taipei City

330

GSK Investigational Site, Taoyuan District

404

GSK Investigational Site, Taichung

807

GSK Investigational Site, Kaohsiung City

1000

GSK Investigational Site, Brussels

1405

GSK Investigational Site, Buenos Aires

2000

GSK Investigational Site, Antwerp

2650

GSK Investigational Site, Hvidovre

5000

GSK Investigational Site, Odense C

6202

GSK Investigational Site, Nice

7505

GSK Investigational Site, Cape Town

7925

GSK Investigational Site, Observatory, Cape Town

8200

GSK Investigational Site, Aarhus

8916

GSK Investigational Site, Badalona, Barcelona

9000

GSK Investigational Site, Ghent

9301

GSK Investigational Site, Bloemfontein

10016

GSK Investigational Site, Taipei

11009

GSK Investigational Site, Cadiz

15006

GSK Investigational Site, A Coruña

18016

GSK Investigational Site, Granada

20007

GSK Investigational Site, Washington D.C.

20017

GSK Investigational Site, Washington D.C.

20127

GSK Investigational Site, Milan

20142

GSK Investigational Site, Milan

20146

GSK Investigational Site, Hamburg

20157

GSK Investigational Site, Milan

20246

GSK Investigational Site, Hamburg

24128

GSK Investigational Site, Bergamo

25123

GSK Investigational Site, Brescia

26506

GSK Investigational Site, Morgantown

27100

GSK Investigational Site, Pavia

28006

GSK Investigational Site, Madrid

28007

GSK Investigational Site, Madrid

28034

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28702

GSK Investigational Site, San Sebastián de los Reyes

30120

GSK Investigational Site, Murcia

30309

GSK Investigational Site, Atlanta

31059

GSK Investigational Site, Toulouse

31401

GSK Investigational Site, Savannah

32503

GSK Investigational Site, Pensacola

33075

GSK Investigational Site, Bordeaux

33407

GSK Investigational Site, West Palm Beach

38010

GSK Investigational Site, Santa Cruz de Tenerife

41013

GSK Investigational Site, Seville

41100

GSK Investigational Site, Modena

44160

GSK Investigational Site, Guadalajara

44280

GSK Investigational Site, Guadalajara

45067

GSK Investigational Site, Orléans

45122

GSK Investigational Site, Essen

45170

GSK Investigational Site, Zapopan

46014

GSK Investigational Site, Valencia

50668

GSK Investigational Site, Cologne

50674

GSK Investigational Site, Cologne

53105

GSK Investigational Site, Bonn

53226

GSK Investigational Site, Milwaukee

59208

GSK Investigational Site, Tourcoing

60596

GSK Investigational Site, Frankfurt am Main

63108

GSK Investigational Site, St Louis

66160

GSK Investigational Site, Kansas City

74127

GSK Investigational Site, Tulsa

75010

GSK Investigational Site, Paris

75012

GSK Investigational Site, Paris

80335

GSK Investigational Site, Munich

80336

GSK Investigational Site, München

81362

GSK Investigational Site, Kaohsiumg

81675

GSK Investigational Site, München

90033

GSK Investigational Site, Los Angeles

92663

GSK Investigational Site, Newport Beach

93000

GSK Investigational Site, Bobigny

94110

GSK Investigational Site, San Francisco

100015

GSK Investigational Site, Beijing

100069

GSK Investigational Site, Beijing

196645

GSK Investigational Site, Saint Petersburg

201508

GSK Investigational Site, Shanghai

400000

GSK Investigational Site, Chongqing

445846

GSK Investigational Site, Tolyatti

510060

GSK Investigational Site, Guangzhou

620149

GSK Investigational Site, Yekaterinburg

06510

GSK Investigational Site, New Haven

08844

GSK Investigational Site, Hillsborough

C1425AWK

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

C1202ABB

GSK Investigational Site, Ciudad de Buenos Aires

S2000PBJ

GSK Investigational Site, Rosario

40110-060

GSK Investigational Site, Salvador

80060-900

GSK Investigational Site, Curitiba

13015-080

GSK Investigational Site, Campinas

69040-000

GSK Investigational Site, Manaus

21040-360

GSK Investigational Site, Rio de Janeiro

01246-090

GSK Investigational Site, São Paulo

04039-032

GSK Investigational Site, São Paulo

V6Z 2T1

GSK Investigational Site, Vancouver

R3A 1R9

GSK Investigational Site, Winnipeg

K1H 8L6

GSK Investigational Site, Ottawa

M5G 2N2

GSK Investigational Site, Toronto

H2L 4E9

GSK Investigational Site, Montreal

H4A 3J1

GSK Investigational Site, Montreal

S4P 0W5

GSK Investigational Site, Regina

DK-2100

GSK Investigational Site, Copenhagen

00149

GSK Investigational Site, Rome

00168

GSK Investigational Site, Rome

06470

GSK Investigational Site, Distrito Federal

07198

GSK Investigational Site, Palma de Mallorca

SE-416 85

GSK Investigational Site, Gothenburg

SE-205 02

GSK Investigational Site, Malmo

SE-118 83

GSK Investigational Site, Stockholm

SE-14186

GSK Investigational Site, Stockholm

LS9 7TF

GSK Investigational Site, Leeds

B9 5SS

GSK Investigational Site, Birmingham

BN2 1ES

GSK Investigational Site, Brighton

BS10 5NB

GSK Investigational Site, Bristol

L7 8XP

GSK Investigational Site, Liverpool

SW10 9TH

GSK Investigational Site, London

WC1E 6LB

GSK Investigational Site, London

M13 0FH

GSK Investigational Site, Manchester

M8 5RB

GSK Investigational Site, Manchester

NE7 7DN

GSK Investigational Site, Newcastle upon Tyne

S10 2JF

GSK Investigational Site, Sheffield

Sponsors
All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

PPD Development, LP

INDUSTRY

lead

ViiV Healthcare

INDUSTRY