Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,049

Participants

Timeline

Start Date

October 27, 2017

Primary Completion Date

June 6, 2019

Study Completion Date

December 31, 2029

Conditions
HIV Infections
Interventions
DRUG

Cabotegravir Tablets

CAB tablets are white to almost white oval shaped film coated 30 mg tablets for oral administration. CAB tablets are to be stored up to 30 degree Celsius and protected from moisture.

DRUG

Rilpivirine Tablets

"RPV tablets are 25 mg tablets that are off-white, round, biconvex, film-coated and debossed on one side with TMC and the other side with 25. RPV tablets should be stored at 25 degree Celsius (excursions permitted to 15 degree-30 degree Celsius) and protected from light."

DRUG

Cabotegravir Injectable Suspension

CAB LA injectable suspension is a sterile white to slightly pink suspension containing 200 mg/mL of GSK1265744 as free acid for administration by IM injection. CAB LA injectable suspension is to be stored at up to 30 degree Celsius and should not be frozen.

DRUG

Rilpivirine Injectable Suspension

RPV LA injectable suspension is a sterile white suspension containing 300 mg/mL of RPV as the free base for administration by IM injection. RPV LA injectable suspension should be kept in the outer package and stored at 2-8 degree Celsius and should not be frozen. RPV LA should also be protected from light.

Trial Locations (118)

1055

GSK Investigational Site, Middelburg

1141

GSK Investigational Site, Buenos Aires

2010

GSK Investigational Site, Darlinghurst

GSK Investigational Site, Sydney

2113

GSK Investigational Site, Johannesburg

4001

GSK Investigational Site, Durban

4052

GSK Investigational Site, Durban

7925

GSK Investigational Site, Cape Town

9300

GSK Investigational Site, Bloemfontein

10029

GSK Investigational Site, New York

10065

GSK Investigational Site, New York

10439

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

14004

GSK Investigational Site, Córdoba

15212

GSK Investigational Site, Pittsburgh

15706

GSK Investigational Site, Santiago de Compostela

18102

GSK Investigational Site, Allentown

20005

GSK Investigational Site, Washington D.C.

20007

GSK Investigational Site, Washington D.C.

20037

GSK Investigational Site, Washington D.C.

20146

GSK Investigational Site, Hamburg

20157

GSK Investigational Site, Milan

20246

GSK Investigational Site, Hamburg

22003

GSK Investigational Site, Annandale

24501

GSK Investigational Site, Lynchburg

25123

GSK Investigational Site, Brescia

27599

GSK Investigational Site, Chapel Hill

28034

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28204

GSK Investigational Site, Charlotte

29010

GSK Investigational Site, Málaga

30625

GSK Investigational Site, Hanover

31059

GSK Investigational Site, Toulouse

31201

GSK Investigational Site, Macon

32690

GSK Investigational Site, Vero Beach

33316

GSK Investigational Site, Fort Lauderdale

34237

GSK Investigational Site, Sarasota

34295

GSK Investigational Site, Montpellier

34982

GSK Investigational Site, Ft. Pierce

35015

GSK Investigational Site, Daejeon

35294

GSK Investigational Site, Birmingham

36312

GSK Investigational Site, Vigo Pontevedra

41013

GSK Investigational Site, Seville

41944

GSK Investigational Site, Daegu

44280

GSK Investigational Site, Guadalajara

45122

GSK Investigational Site, Essen

46014

GSK Investigational Site, Valencia

49241

GSK Investigational Site, Pusan

53127

GSK Investigational Site, Bonn

55415

GSK Investigational Site, Minneapolis

59208

GSK Investigational Site, Tourcoing

60590

GSK Investigational Site, Frankfurt

60596

GSK Investigational Site, Frankfurt

60611

GSK Investigational Site, Chicago

63110

GSK Investigational Site, St Louis

68198

GSK Investigational Site, Omaha

75012

GSK Investigational Site, Paris

75013

GSK Investigational Site, Paris

75018

GSK Investigational Site, Paris

75246

GSK Investigational Site, Dallas

75475

GSK Investigational Site, Paris

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

80246

GSK Investigational Site, Denver

80337

GSK Investigational Site, München

85015

GSK Investigational Site, Phoenix

90027

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

92264

GSK Investigational Site, Palm Springs

93200

GSK Investigational Site, Saint-Denis

93301

GSK Investigational Site, Bakersfield

94109

GSK Investigational Site, San Francisco

94110

GSK Investigational Site, San Francisco

94118

GSK Investigational Site, San Francisco

115035

GSK Investigational Site, Moscow

190103

GSK Investigational Site, Saint Petersburg

193167

GSK Investigational Site, Saint Petersburg

196645

GSK Investigational Site, Saint Petersburg

214006

GSK Investigational Site, Smolensk

302040

GSK Investigational Site, Oryol

350015

GSK Investigational Site, Krasnodar

398043

GSK Investigational Site, Lipetsk

410009

GSK Investigational Site, Saratov

420097

GSK Investigational Site, Kazan'

445846

GSK Investigational Site, Toliyatti

620102

GSK Investigational Site, Yekaterinburg

650056

GSK Investigational Site, Kemerovo

30912-3130

GSK Investigational Site, Augusta

02129

GSK Investigational Site, Boston

45267-0405

GSK Investigational Site, Cincinnati

C1202ABB

GSK Investigational Site, Buenos Aires

C1405CKC

GSK Investigational Site, Ciudad Autonoma de Bueno

S2000PBJ

GSK Investigational Site, Rosario

Prahran 3181

GSK Investigational Site, Prahran

K1H 8L6

GSK Investigational Site, Ottawa

M5G 1K2

GSK Investigational Site, Toronto

H2L 4E9

GSK Investigational Site, Montreal

H4A 3J1

GSK Investigational Site, Montreal

G1V 4G2

GSK Investigational Site, Québec

S4P 0W5

GSK Investigational Site, Regina

03722

GSK Investigational Site, Seoul

06591

GSK Investigational Site, Seoul

08916

GSK Investigational Site, Badalona

08003

GSK Investigational Site, Barcelona

08035

GSK Investigational Site, Barcelona

08036

GSK Investigational Site, Barcelona

03203

GSK Investigational Site, Elche Alicante

SE-416 85

GSK Investigational Site, Gothenburg

SE-118 83

GSK Investigational Site, Stockholm

SE-14186

GSK Investigational Site, Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

ViiV Healthcare

INDUSTRY

NCT03299049 - Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults | Biotech Hunter | Biotech Hunter