Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the
      body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in
      healthy, HIV-uninfected adults.
    

Detailed description: 
      This study will evaluate GSK1265744, which is an investigational, injectable HIV medicine.
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      GSK1265744 in healthy, HIV-uninfected adults.

      This study will enroll two cohorts of participants (Cohort 1 and Cohort 2). Within each
      cohort, participants will be randomly assigned to one of two groups: Group 1 will receive
      GSK1265744 tablets (also called oral 744) and injections (also called GSK1265744 long acting
      or 744LA), and Group 2 will receive placebo tablets and injections. Participants in Cohort 1
      will attend several study visits through Week 81 or Week 105. Participants in Cohort 2 will
      attend several study visits through Week 85 or Week 109. From study entry through Week 4,
      participants in both cohorts will take a GSK1265744 tablet (Group 1) or a placebo tablet
      (Group 2) once a day. For 1 week after participants stop taking their assigned tablets, study
      researchers will assess safety and tolerability. If no safety or tolerability concerns are
      identified, participants will enter the injection phase of the study. Participants in Cohort
      1 will receive two injections of GSK1265744 (Group 1) or placebo (Group 2) at Weeks 5, 17,
      and 29. Participants in Cohort 2 will receive one injection of GSK1265744 (Group 1) or
      placebo (Group 2) at Weeks 5, 9, 17, 25, and 33.

      All study visits will include HIV counseling, a physical examination, a medical history
      review, and a blood collection. Select study visits will include adherence counseling,
      central nervous system (CNS) symptom assessment, behavioral and acceptability assessments, a
      urine collection, an electrocardiogram (ECG), and rectal and/or vaginal swabs.
    

Intervention name(s): GSK1265744 Tablets; Injectable GSK1265744; Placebo for GSK1265744 Tablets; Injectable Placebo for GSK1265744
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 30-mg tablets, taken orally; Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections
Cohort 2: 600-mg injection, administered as one IM gluteal injection; Taken orally; Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections
Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection
Other intervention name(s): Oral 744; GSK1265744 long acting; 744LA
Intervention MeSH terms: Cabotegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention