Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
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query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>HIV-1 infection with or without Hepatitis B or C infection</li>\n<li>Stable antiretroviral regimen containing efavirenz and nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) for at least 1 month</li>\n<li>Mild, moderate or severe hepatic impairment with hepatic cirrhosis</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Acute flare of hepatitis</li>\n<li>Positive pregnancy test for a female</li>\n<li>Significant acute medical illness in past 2 months</li>\n<li>Use of agents known to significantly affect liver metabolism</li>\n<li>Change in medications to treat a chronic disease in the past 2 months</li>\n</ul>\n</p>', created = 1283571407, expire = 1283657807, headers = '', serialized = 0 WHERE cid = '1:ca3d5af6a1aa57d2ecf745b5a511405d' in /persistent/html/includes/cache.inc on line 109.
Trial phase:
Phase I
Recruitment status:
Active, not recruiting
The purpose of this clinical research is to learn if Efavirenz PK is different in HIV-1 infected subjects with hepatic (liver) impairment. Subjects will already be on Efavirenz for HIV-1 infection. Goal is to observe pharmacokinetics of Efavirenz in this patient population with HIV-1 infection and various degrees of hepatic impairment.