Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers

Trial Profile

Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers

Recruiting
Phase of Trial: Phase I

Latest Information Update: 25 Oct 2017

At a glance

  • Drugs Cobicistat/darunavir (Primary) ; Dolutegravir (Primary) ; Isoniazid; Pyridoxine; Rifapentine
  • Indications HIV infections; HIV-1 infections
  • Focus Pharmacokinetics
  • Most Recent Events

    • 08 Jul 2017 Planned number of patients changed from 60 to 30.
    • 01 Jul 2017 Status changed from suspended to recruiting.
    • 29 Mar 2017 As per correspondence with investigator Brooks, Kristina (kristina.brooks@nih.gov) dated 29 Mar 2017, the first arm (dolutegravir once-daily) was terminated due to the development of adverse events in the first few subjects enrolled. However, the second arm (darunavir with cobicistat) is still planned and the trial status is suspended.
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