NCT03813979

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an open-label, parallel-group, nonrandomized, multi-centre, phase-IV, single dose trial. The primary aim of this study is to assess the pharmacokinetics of a single dose of 50mg of dolutegravir in HIV-seronegative subjects with severe hepatic impairment (n=8) and compare these with a single dose of 50mg of dolutegravir in matched controls (n=8). In both groups a pharmacokinetic (PK) curve will be recorded for determination of dolutegravir (and dolutegravir-glucuronide).

Conditions

• HIV-1-infection
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Dolutegravir	Intake of a single-dose dolutegravir 50 mg tablet on an empty stomach

Timeline

• Start date: 2020-11-15
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-01-23
• Last updated: 2021-06-10