A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions
NCT ID: NCT00144248
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
51 participants
INTERVENTIONAL
2004-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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nevirapine
Eligibility Criteria
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Inclusion Criteria
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..
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Boehringer Ingelheim Investigational Site
Bakersfield, California, United States
Boehringer Ingelheim Investigational Site
San Francisco, California, United States
California Pacific Medical Center
San Francisco, California, United States
Albany Medical College, MC 142
Albany, New York, United States
Boehringer Ingelheim Investigational Site
Providence, Rhode Island, United States
Hopital de l'Hotel Dieu
Lyon, , France
Hopital Pitie Salpetriere
Paris, , France
Hospital Clinico y Provincial de Barcelona - HIV
Barcelona, , Spain
Countries
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Related Links
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Related Info
Other Identifiers
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1100.1448
Identifier Type: -
Identifier Source: org_study_id