A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT00144248
• Date of registration: 02/09/2005
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions
• Scientific title: A Pharmacokinetic Study to Assess Nevirapine Levels in HIV-infected Patients With Impaired Hepatic Function
• Date of first enrolment: June 25, 2004
• Target sample size: 51
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00144248
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France, Spain, United States

Contacts

• Name: Boehringer Ingelheim Study Coordinator
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

INCLUSION

1. Male or female subjects >=18 years of age with HIV-1 infection and chronic liver
disease as reflected by a documented biopsy with hepatic fibrosis present.

2. a. 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 sample collection.

b. Participants receiving nevirapine 400 mg once daily as part of a stable ARV regimen
for a minimum of 6 weeks, who are willing to switch to nevirapi0 mg twice daily for a
minimum of 14 days prior to trough collection.

3. Participants must have uoxylin and Eosin (H and E) stained slide and one trichrome
stained pathology slide available at the time of enrollment. There is no time
restriction on liver biopsy slides that pathologically confirm the presence of
cirrhosis. The presence of cirrhosis must be documented on the liver biopsy report.

EXCLUSION

1. Current (within the past 4 weeks) HIV antiviral therapy with other NNRTI's.

2. Concurrent use (within the past 7 days) of any of the following:

1. Systemic azole antifungal agents (fluconazole, itraconazole, ketoconazole, etc.)

2. Clarithromycin

3. Rifampin

4. St John's Wort

3. Inability to provide a blood sample.

4. Patients who have evidence for hepatic or other encephalopathy above Grade 1

5. Patients with renal failure who require dialysis.

6. Pregnant and/or breast feeding women..



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatic Insufficiency

HIV Infections

Intervention(s)

Drug: nevirapine

Primary Outcome(s)

The primary endpoints are the degree of hepatic impairment, steady state nevirapine clearance, and the increase in estimated clearance when trough is supplemented by plasma levels measured one, two and four hours after nevirapine administration [Time Frame: Up to 4 hours]

Secondary Outcome(s)

Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis. [Time Frame: Up to 14 hours]

Secondary ID(s)

1100.1448

Source(s) of Monetary Support

Please refer to primary and secondary sponsors