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You can access this
clinical trial
if you have
Infection, Human Immunodeficiency Virus
and you are
between 18 and 65
years old
1
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