Conditions: Infection, Human Immunodeficiency Virus
Keywords: Pre-Exposure Prophylaxis HIV integrase Intramuscular Injection GSK1265744
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 127
Healthy volunteers: yes

Brief 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

Detailed description:

Arms:
arm 1: Participants will receive daily oral 744 (30 mg tablets) for 4 weeks, followed by a one week washout period followed by intra-muscular (IM) injections of 800 mg of 744 LA at three time points at 12 week intervals as: Week 5, Week 17, and Week 29 arm 2: Participants will receive daily oral matching placebo for 4 weeks, followed by a one week washout period followed by intra-muscular (IM) injections of saline at three time points at 12 week intervals as: Week 5, Week 17, and Week 29

Interventions: intervention 1: 744 Tablet intervention 2: 744 LA Injection intervention 3: Placebo Tablet intervention 4: Placebo Injection
Intervention descriptions: intervention 1: White to almost white oval shaped film coated 30 mg tablets for oral administration intervention 2: Sterile white to slightly coloured suspension containing 200 mg/mL of 744 as free acid for administration by intramuscular (IM) injection intervention 3: Microcrystalline cellulose, Opadry film-coating, white OY-S-28876 intervention 4: Sterile saline 0.9% Sodium Chloride Injection

Protocol document: