Overview

Pharmacokinetics of Single-dose Dolutegravir in HIV-seronegative Subjects With Severe Hepatic Impairment Compared to Matched Controls.

Status:
Withdrawn
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This is an open-label, parallel-group, nonrandomized, multi-centre, phase-IV, single dose trial in 8 HIV-seronegative subjects with severe hepatic impairment and 8 matched controls to assess the pharmacokinetics of a single dose of 50mg of dolutegravir in subjects with severe hepatic impairment.
Phase:
Phase 4
Details
Lead Sponsor:
Radboud University
Collaborators:
Erasmus Medical Center
Leiden University Medical Center
University Medical Center Groningen
Treatments:
Dolutegravir