Study to Evaluate the Safety Tolerability and Acceptability of Long Acting Injections of the Human Immunodeficiency Virus (HIV) Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR)

PHASE2CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

March 27, 2014

Primary Completion Date

May 15, 2015

Study Completion Date

February 23, 2016

Conditions
Infection, Human Immunodeficiency Virus
Interventions
DRUG

744 Tablet

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

DRUG

744 LA Injection

Sterile white to slightly coloured suspension containing 200 mg/mL of 744 as free acid for administration by intramuscular (IM) injection

DRUG

Placebo Tablet

Microcrystalline cellulose, Opadry film-coating, white OY-S-28876

DRUG

Placebo Injection

Sterile saline 0.9% Sodium Chloride Injection

Trial Locations (10)

10016

GSK Investigational Site, New York

10032

GSK Investigational Site, New York

10065

GSK Investigational Site, New York

19104

GSK Investigational Site, Philadelphia

20005

GSK Investigational Site, Washington D.C.

23606

GSK Investigational Site, Newport News

30339

GSK Investigational Site, Atlanta

87505

GSK Investigational Site, Santa Fe

94158

GSK Investigational Site, San Francisco

02215

GSK Investigational Site, Boston

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

ViiV Healthcare

INDUSTRY