Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine

PHASE2CompletedINTERVENTIONAL
Enrollment

244

Participants

Timeline

Start Date

August 6, 2012

Primary Completion Date

October 10, 2013

Study Completion Date

January 15, 2019

Conditions
Infection, Human Immunodeficiency VirusHIV Infections
Interventions
DRUG

GSK1265744 10 mg

GSK1265744 10 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.

DRUG

GSK1265744 30 mg

GSK1265744 30 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.

DRUG

GSK1265744 60 mg

GSK1265744 60 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.

DRUG

Efavirenz 600 mg

Efavirenz 600 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase and Maintenance Phase of the study.

DRUG

Rilpivirine 25 mg

Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.

DRUG

Placebo

Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.

DRUG

Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)

The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.

Trial Locations (48)

10065

GSK Investigational Site, New York

10595

GSK Investigational Site, Valhalla

12209

GSK Investigational Site, Albany

14201

GSK Investigational Site, Buffalo

20007

GSK Investigational Site, Washington D.C.

20037

GSK Investigational Site, Washington D.C.

22003

GSK Investigational Site, Annandale

27599

GSK Investigational Site, Chapel Hill

29425

GSK Investigational Site, Charleston

30339

GSK Investigational Site, Atlanta

30912

GSK Investigational Site, Augusta

31201

GSK Investigational Site, Macon

31401

GSK Investigational Site, Savannah

32803

GSK Investigational Site, Orlando

33137

GSK Investigational Site, Miami

33308

GSK Investigational Site, Fort Lauderdale

33309

GSK Investigational Site, Oakland Park

33316

GSK Investigational Site, Fort Lauderdale

33407

GSK Investigational Site, West Palm Beach

34982

GSK Investigational Site, Ft. Pierce

35294

GSK Investigational Site, Birmingham

46202

GSK Investigational Site, Indianapolis

55415

GSK Investigational Site, Minneapolis

64111

GSK Investigational Site, Kansas City

68198

GSK Investigational Site, Omaha

72207

GSK Investigational Site, Little Rock

75246

GSK Investigational Site, Dallas

78751

GSK Investigational Site, Austin

80209

GSK Investigational Site, Denver

85015

GSK Investigational Site, Phoenix

89106

GSK Investigational Site, Las Vegas

90069

GSK Investigational Site, Los Angeles

90211

GSK Investigational Site, Beverly Hills

90813

GSK Investigational Site, Long Beach

93301

GSK Investigational Site, Bakersfield

94115

GSK Investigational Site, San Francisco

02111

GSK Investigational Site, Boston

08844

GSK Investigational Site, Hillsborough

07753

GSK Investigational Site, Neptune City

02906

GSK Investigational Site, Providence

V6Z 2C7

GSK Investigational Site, Vancouver

V6Z 2T1

GSK Investigational Site, Vancouver

M4N 3M5

GSK Investigational Site, Toronto

M4T 3A7

GSK Investigational Site, Toronto

M5G 1K2

GSK Investigational Site, Toronto

H2L 4E9

GSK Investigational Site, Montreal

H2L 4P9

GSK Investigational Site, Montreal

H3A 1T1

GSK Investigational Site, Montreal

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

ViiV Healthcare

INDUSTRY