A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen

PHASE3CompletedINTERVENTIONAL
Enrollment

555

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

April 30, 2015

Study Completion Date

December 31, 2015

Conditions
Infection, Human Immunodeficiency Virus
Interventions
DRUG

ABC/DTG/3TC FDC

Purple, oval, biconvex tablets containing 702 mg Abacavir sulphate which is equivalent to 600 mg ABC, 52.62 mg Dolutegravir sodium which is equivalent to 50 mg Dolutegravir free acid and 300 mg 3TC

DRUG

Ongoing cART regimen

Stable cART regimens including boosted PI (or ATV unboosted) + 2 NRTIs; NNRTI + 2 NRTIs, or INI (RAL or EVG)+ 2 NRTIs

Trial Locations (103)

10001

GSK Investigational Site, New York

10467

GSK Investigational Site, The Bronx

10595

GSK Investigational Site, Valhalla

11030

GSK Investigational Site, Manhasset

14215

GSK Investigational Site, Buffalo

15212

GSK Investigational Site, Pittsburgh

18102

GSK Investigational Site, Allentown

19107

GSK Investigational Site, Philadelphia

20007

GSK Investigational Site, Washington D.C.

20009

GSK Investigational Site, Washington D.C.

20036

GSK Investigational Site, Washington D.C.

20037

GSK Investigational Site, Washington D.C.

22003

GSK Investigational Site, Annandale

24501

GSK Investigational Site, Lynchburg

27401

GSK Investigational Site, Greensboro

28207

GSK Investigational Site, Charlotte

29425

GSK Investigational Site, Charleston

30033

GSK Investigational Site, Decatur

30308

GSK Investigational Site, Atlanta

30312

GSK Investigational Site, Atlanta

30339

GSK Investigational Site, Atlanta

31405

GSK Investigational Site, Savannah

32209

GSK Investigational Site, Jacksonville

32504

GSK Investigational Site, Pensacola

32803

GSK Investigational Site, Orlando

33133

GSK Investigational Site, Miami

33136

GSK Investigational Site, Miami

33316

GSK Investigational Site, Fort Lauderdale

33401

GSK Investigational Site, West Palm Beach

33614

GSK Investigational Site, Tampa

34982

GSK Investigational Site, Ft. Pierce

44304

GSK Investigational Site, Akron

46202

GSK Investigational Site, Indianapolis

48072

GSK Investigational Site, Berkley

48109

GSK Investigational Site, Ann Arbor

52242

GSK Investigational Site, Iowa City

55407

GSK Investigational Site, Minneapolis

55415

GSK Investigational Site, Minneapolis

60612

GSK Investigational Site, Chicago

63108

GSK Investigational Site, St Louis

63110

GSK Investigational Site, St Louis

63139

GSK Investigational Site, St Louis

64111

GSK Investigational Site, Kansas City

70121

GSK Investigational Site, New Orleans

74127

GSK Investigational Site, Tulsa

75208

GSK Investigational Site, Dallas

75246

GSK Investigational Site, Dallas

75605

GSK Investigational Site, Longview

76104

GSK Investigational Site, Fort Worth

77098

GSK Investigational Site, Houston

77401

GSK Investigational Site, Bellaire

78705

GSK Investigational Site, Austin

80209

GSK Investigational Site, Denver

85012

GSK Investigational Site, Phoenix

85015

GSK Investigational Site, Phoenix

87505

GSK Investigational Site, Santa Fe

89031

GSK Investigational Site, Las Vegas

90028

GSK Investigational Site, Los Angeles

90033

GSK Investigational Site, Los Angeles

90035

GSK Investigational Site, Los Angeles

90036

GSK Investigational Site, Los Angeles

90069

GSK Investigational Site, Los Angeles

90211

GSK Investigational Site, Beverly Hills

90502

GSK Investigational Site, Torrance

90813

GSK Investigational Site, Long Beach

92103

GSK Investigational Site, San Diego

92663

GSK Investigational Site, Newport Beach

93301

GSK Investigational Site, Bakersfield

94109

GSK Investigational Site, San Francisco

94115

GSK Investigational Site, San Francisco

94118

GSK Investigational Site, San Francisco

94577

GSK Investigational Site, San Leandro

94602

GSK Investigational Site, Oakland

95825

GSK Investigational Site, Sacramento

96813

GSK Investigational Site, Honolulu

98104

GSK Investigational Site, Seattle

80205-5422

GSK Investigational Site, Denver

06850

GSK Investigational Site, Norwalk

32960-6571

GSK Investigational Site, Vero Beach

30912-3130

GSK Investigational Site, Augusta

60612-3833

GSK Investigational Site, Chicago

01105

GSK Investigational Site, Springfield

08103

GSK Investigational Site, Camden

08844

GSK Investigational Site, Hillsborough

07102

GSK Investigational Site, Newark

45267-0405

GSK Investigational Site, Cincinnati

75390-9113

GSK Investigational Site, Dallas

T2R 0X7

GSK Investigational Site, Calgary

V6Z 2C7

GSK Investigational Site, Vancouver

V6Z 2T1

GSK Investigational Site, Vancouver

V8W 1M8

GSK Investigational Site, Victoria

R3A 1R9

GSK Investigational Site, Winnipeg

M4N 3M5

GSK Investigational Site, Toronto

M4T 3A7

GSK Investigational Site, Toronto

M5G 1K2

GSK Investigational Site, Toronto

M5G 2N2

GSK Investigational Site, Toronto

H2L 4P9

GSK Investigational Site, Montreal

H2L 5B1

GSK Investigational Site, Montreal

H3A 1T1

GSK Investigational Site, Montreal

00717-1567

GSK Investigational Site, Ponce

00935

GSK Investigational Site, Rio Piedras

00936-8344

GSK Investigational Site, San Juan

00909

GSK Investigational Site, San Juan

Sponsors
All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

collaborator

GlaxoSmithKline

INDUSTRY

lead

ViiV Healthcare

INDUSTRY