A pharmacokinetic study to assess Nevirapine levels in HIV-infected patients with impaired hepatic function.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000175-17-ES

Enrollment

Registered

2006-04-25

Start date

2005-05-31

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of HIV infection

Interventions

Trade Name: Viramune tablets Product Name: Viramune 200 mg Tablets Pharmaceutical Form: Tablet INN or Proposed INN: NEVIRAPINA ANHIDRA Concentration unit: mg milligram(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female =18 years of age with HIV-1 infection and chronic liver disease as reflected by a documented biopsy with hepatic fibrosis present. - Participants must be receiving nevirapine 200 mg twice daily as part of a stable ARV regimen for a minimum of 6 weeks prior to trough level plasma collection. - Participants must have undergone liver biopsy within 24 months prior to enrollment and have a pathology report and at least one Hematoxylin and Eosin stained slide and one trichrome stained pathology slide available at the time of enrollment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Current (within past 4 weeks) HIV antiviral theraphy with other NNRTI's and/or any PI. - Concurrent use (within the past seven days) of any of the following: Systemic azole antifungal agents, Clarithromycin, Rifampin, St. John's Wort - Patients who have evidence for hepatic or other encephalopathy above Grade 1. - Patients with renal failure who require dialysis.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the steady state clearance of nevirapine among hepatically impaired patients, and to examine whether the degree of hepatic impairment influences clearance;Secondary Objective: Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis;Primary end point(s): - Degree of hepatic impairment - steady state nevirapine clearance - increase in estimated clearance when trough is supplemented by plasma levels measured one, two and four hours after nevirapine administration.	—

Measure

Time frame

Main Objective: To evaluate the steady state clearance of nevirapine among hepatically impaired patients, and to examine whether the degree of hepatic impairment influences clearance;Secondary Objective: Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis;Primary end point(s): - Degree of hepatic impairment - steady state nevirapine clearance - increase in estimated clearance when trough is supplemented by plasma levels measured one, two and four hours after nevirapine administration.

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Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026