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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00144248 |
To evaluate the correlation between the degree of hepatic impairment based on liver biopsy score (mild, moderate, severe) and plasma levels of nevirapine [Viramune] and its metabolites
Condition | Intervention | Phase |
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HIV Infections Hepatic Insufficiency |
Drug: nevirapine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment |
Official Title: | Evaluation of Nevirapine Levels in Hepatically Impaired Patients |
Estimated Enrollment: | 60 |
Estimated Study Completion Date: | November 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION
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.
EXCLUSION
Concurrent use (within the past 7 days) of any of the following:
United States, California | |
Boehringer Ingelheim Investigational Site | |
San Francisco, California, United States | |
Boehringer Ingelheim Investigational Site | |
Bakersfield, California, United States | |
California Pacific Medical Center | |
San Francisco, California, United States | |
United States, New York | |
Albany Medical College, MC 142 | |
Albany, New York, United States | |
United States, Rhode Island | |
Boehringer Ingelheim Investigational Site | |
Providence, Rhode Island, United States | |
France | |
Hopital Pitie Salpetriere | |
Paris, France | |
Hopital de l'Hotel Dieu | |
Lyon cedex 02, France | |
Spain | |
Hospital Clinico y Provincial de Barcelona - HIV | |
Barcelona, Spain |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
Study ID Numbers: | 1100.1448 |
Study First Received: | September 2, 2005 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00144248 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Nevirapine Liver Diseases Sexually Transmitted Diseases, Viral Digestive System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes Hepatic Insufficiency |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |