NCT02120352 - A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects | Biotech Hunter

Enrollment

309

Participants

Timeline

Start Date

April 28, 2014

Primary Completion Date

August 13, 2015

Study Completion Date

April 20, 2023

Conditions

Infection, Human Immunodeficiency VirusHIV Infections

Interventions

DRUG

CAB Oral Tablets

White to almost white oval shaped film coated 30 mg tablets for oral administration.

DRUG

CAB LA

Sterile white to slightly colored suspension containing 200 mg/mL of GSK744 as free acid (GSK1265744 free acid), polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection, packaged in a 3 mL USP Type I glass vial, for administration by IM injection

DRUG

ABC/3TC Oral tablets

ABC/3TC fixed dose combination (FDC) oral tablet, containing 600 mg of ABC (as abacavir sulfate) and 300 mg of 3TC

DRUG

RPV Oral Tablets

Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration. Eligible subjects switching from the oral regimen to the IM regimen in the Extension Period will receive 2 weeks of RPV 25 mg once daily, from Week 102 through Week 104

OTHER

HAART

Higly-active antiretroviral therapy chosen by participant based on investigator recommendations and based on availability.

DRUG

RPV

Sterile white suspension containing 300 mg/mL of TMC278 as free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection, packaged in a 2 mL USP Type I glass vial, for administration by IM injection.

Trial Locations (50)

10439

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

13274

GSK Investigational Site, Marseille

13353

GSK Investigational Site, Berlin

20146

GSK Investigational Site, Hamburg

20246

GSK Investigational Site, Hamburg

27514

GSK Investigational Site, Chapel Hill

28007

GSK Investigational Site, Madrid

28040

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

30625

GSK Investigational Site, Hanover

31401

GSK Investigational Site, Savannah

33316

GSK Investigational Site, Fort Lauderdale

34982

GSK Investigational Site, Ft. Pierce

35294

GSK Investigational Site, Birmingham

44093

GSK Investigational Site, Nantes

53127

GSK Investigational Site, Bonn

55415

GSK Investigational Site, Minneapolis

60596

GSK Investigational Site, Frankfurt am Main

68198

GSK Investigational Site, Omaha

69437

GSK Investigational Site, Lyon

75018

GSK Investigational Site, Paris

75246

GSK Investigational Site, Dallas

75571

GSK Investigational Site, Paris

75970

GSK Investigational Site, Paris

78705

GSK Investigational Site, Austin

80246

GSK Investigational Site, Denver

80337

GSK Investigational Site, Munich

90069

GSK Investigational Site, Los Angeles

90211

GSK Investigational Site, Beverly Hills

90813

GSK Investigational Site, Long Beach

93009

GSK Investigational Site, Bobigny

93205

GSK Investigational Site, Saint-Denis

93301

GSK Investigational Site, Bakersfield

02904

GSK Investigational Site, Providence

V6Z 2C7

GSK Investigational Site, Vancouver

R3A 1R9

GSK Investigational Site, Winnipeg

K1H 8L6

GSK Investigational Site, Ottawa

M5G 1K2

GSK Investigational Site, Toronto

H2L 4E9

GSK Investigational Site, Montreal

H2L 4P9

GSK Investigational Site, Montreal

H3A 1T1

GSK Investigational Site, Montreal

H4A 3J1

GSK Investigational Site, Montreal

06202

GSK Investigational Site, Nice

08916

GSK Investigational Site, Badalona

08025

GSK Investigational Site, Barcelona

08036

GSK Investigational Site, Barcelona

08907

GSK Investigational Site, Barcelona

?03203

GSK Investigational Site, Elche