Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)

PHASE3CompletedINTERVENTIONAL
Enrollment

518

Participants

Timeline

Start Date

April 21, 2015

Primary Completion Date

September 16, 2016

Study Completion Date

May 25, 2023

Conditions
HIV Infections
Interventions
DRUG

DTG 50 mg

Participants received one oral tablet of 50 mg DTG daily administered concomitantly with RPV. Each DTG tablet contained 52.62 mg dolutegravir sodium salt, which was equivalent to 50 mg dolutegravir free acid.

DRUG

RPV 25 mg

"Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.~Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148), one oral tablet of 25 mg RPV daily administered concomitantly with DTG along with a meal. Each RPV tablet contained 27.5 mg of rilpivirine hydrochloride, which was equivalent to 25 mg of RPV."

DRUG

CAR

CAR included the following combinations: 2 NRTIs + 1 INI, 2 NRTIs + 1 NNRTI, or 2 NRTIs + 1 PI.

Trial Locations (61)

220

GSK Investigational Site, New Taipei City

807

GSK Investigational Site, Kaohsiung City

824

GSK Investigational Site, Kaohsiung City

1141

GSK Investigational Site, Buenos Aires

2000

GSK Investigational Site, Rosario

2010

GSK Investigational Site, Darlinghurst

GSK Investigational Site, Sydney

10243

GSK Investigational Site, Berlin

12157

GSK Investigational Site, Berlin

13003

GSK Investigational Site, Marseille

14201

GSK Investigational Site, Buffalo

15006

GSK Investigational Site, A Coruña

15706

GSK Investigational Site, Santiago de Compostela

20007

GSK Investigational Site, Washington D.C.

20037

GSK Investigational Site, Washington D.C.

20157

GSK Investigational Site, Milan

24127

GSK Investigational Site, Bergamo

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28935

GSK Investigational Site, Móstoles

30003

GSK Investigational Site, Murcia

30202

GSK Investigational Site, Cartagena

30625

GSK Investigational Site, Hanover

31201

GSK Investigational Site, Macon

32690

GSK Investigational Site, Vero Beach

33000

GSK Investigational Site, Bordeaux

33011

GSK Investigational Site, Oviedo

33316

GSK Investigational Site, Fort Lauderdale

33407

GSK Investigational Site, West Palm Beach

38320

GSK Investigational Site, Santa Cruz La Laguna

40705

GSK Investigational Site, Taichung

46014

GSK Investigational Site, Valencia

48075

GSK Investigational Site, Southfield

50937

GSK Investigational Site, Cologne

53127

GSK Investigational Site, Bonn

59208

GSK Investigational Site, Tourcoing

68198

GSK Investigational Site, Omaha

69317

GSK Investigational Site, Lyon

75970

GSK Investigational Site, Paris

78705

GSK Investigational Site, Austin

93205

GSK Investigational Site, Saint-Denis

93301

GSK Investigational Site, Bakersfield

98104

GSK Investigational Site, Seattle

190103

GSK Investigational Site, Saint Petersburg

350015

GSK Investigational Site, Krasnodar

410009

GSK Investigational Site, Saratov

656010

GSK Investigational Site, Barnaul

27599-7064

GSK Investigational Site, Chapel Hill

C1202ABB

GSK Investigational Site, Buenos Aires

H2L 4E9

GSK Investigational Site, Montreal

H2L 4P9

GSK Investigational Site, Montreal

H3A 1T1

GSK Investigational Site, Montreal

H4A 3J1

GSK Investigational Site, Montreal

S4P 0W5

GSK Investigational Site, Regina

M4N 3M5

GSK Investigational Site, Toronto

V6Z 2T1

GSK Investigational Site, Vancouver

03010

GSK Investigational Site, Alicante

08916

GSK Investigational Site, Badalona

08035

GSK Investigational Site, Barcelona

08097

GSK Investigational Site, Barcelona

NW3 2QG

GSK Investigational Site, London

Sponsors
All Listed Sponsors
collaborator

Janssen Pharmaceuticals

INDUSTRY

collaborator

GlaxoSmithKline

INDUSTRY

lead

ViiV Healthcare

INDUSTRY