NCT02076178

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)

A Phase IIa Study to Evaluate the Safety, Tolerability and Acceptability of Long Acting Injections of the HIV Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a Phase IIa, randomized, multi-site, two-arm, double-blinded study to evaluate the safety, tolerability, and acceptability of GSK1265744 long acting injectable formulation (744 LA) in adult male subjects. To evaluate the safety and tolerability of the injectable agent, 744 LA (800 milligrams (mg) dose administered at three time points at 12 week intervals) through Week 41 in HIV-uninfected men. Eligible participants will be randomized in a 5:1 ratio to receive 744 LA or matching placebo. Participants will receive daily oral 744 (30 mg tablets) or matching placebo for 4 weeks during the Oral Phase of the study, followed by a one week washout period. Following safety lab assessments from the Oral Phase, participants will enter the Injection Phase and receive Intramuscular (IM) injections of 744 LA or placebo at three time points at 12 week intervals. IM injections will consist of 800 mg of 744 or a matching control

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-03-27
• Primary completion: 2015-05-15
• Completion: 2016-02-23
• First posted: 2014-03-03
• Last updated: 2017-12-15
• Results posted: 2017-12-15

Locations

10 sites across 1 country: United States