The objective of this study was to evaluate the steady-state clearance of nevirapine among HIV-1 positive patients with hepatic fibrosis, and to examine whether the degree of hepatic impairment influences clearance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
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
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
Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis.
Time frame: Up to 14 hours
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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