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Your journey
1What's a trial
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More info
You can access this
clinical trial
if you have
Infection, Human Immunodeficiency Virus
and you are
between 18 and 65
years old
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

CAB is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment and prevention of human immunodeficiency virus-1 (HIV-1) infection. RIF, a rifamycin used for treatment of tuberculosis (common co-infection in HIV-infected subjects), is a known inducer of uridine diphosphate (UDP)-glucuronosyltransferases (UGTs) and Cytochrome P450 3A4 (CYP3A4). CAB is primarily metabolized via UGT1A1 and UGT1A9, thus a drug interaction between CAB and RIF is possible. This study will be a phase I, single-center, open label, fixed-sequence cross-over study to compare the single dose PK of CAB oral 30 milligrams (mg) when co-administered with RIF 600 mg once daily at steady-state to those of CAB oral 30 mg administered alone. Fifteen subjects are planned to be enrolled to obtain 12 evaluable subjects for this study.

Provided treatments

  • Drug: CAB
  • Drug: RIF
Tris trial is registered with FDA with number: NCT02411435. The sponsor of the trial is ViiV Healthcare and it is looking for 15 volunteers for the current phase.
Official trial title:
Phase I, Single-center, Open Label, Fixed-sequence Cross-over Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects