This trial is completed!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
2Find
3Review
4Get in touch
More info
You can access this
clinical trial
if you have
Infection, Human Immunodeficiency Virus
and you are
between 18 and 64
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
Show me locations

The purpose

LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety, tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a long acting parenteral (LAP) formulation in healthy subjects. Subjects will be randomized to 3 monthly dosing cohorts and 1 quarterly dosing cohort with either intramuscular or subcutaneous dosing. In the monthly dosing cohorts subjects will receive GSK1265744 alone for 2 months and then in combination with TMC278 long acting parenteral (LA) for 2 months. For the quarterly dosing cohort, 2 quarterly intramuscular doses of GSK1265744 LAP will be given alone. Three dose levels of GSK1265744 will be evaluated partly in combination with TMC278 LA to adequately characterize the GSK1265744 LAP and TMC278 LA safety, tolerability, and PK profile. A total enrolment of approximately 40 healthy subjects is planned for this study.

Provided treatments

  • Drug: GSK1265744 Oral
  • Drug: GSK1265744 LAP 800mg intramuscular injection
  • Drug: GSK1265744 LAP 200mg subcutaneous injection
  • Drug: GSK1265744 LAP 200mg intramuscular injection
  • Drug: GSK1265744 LAP 400mg intramuscular injection
  • Drug: TMC278 LA 1200mg intramuscular injection
  • Drug: TMC278 LA 600mg intramuscular injection
  • Drug: GSK1265744 LAP 800mg intramuscular injection

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01593046. The sponsor of the trial is ViiV Healthcare and it is looking for 43 volunteers for the current phase.
Official trial title:
A Randomized, Open Label Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects