Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; HIV Infections

Treatments: Drug: efavirenz containing antiretroviral regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162097

AI266-917

Details and patient eligibility

About

The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or normal hepatic function.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-1 infection with or without Hepatitis B or C infection
• Stable antiretroviral regimen containing efavirenz and nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) for at least 1 month
• Mild, moderate or severe hepatic impairment with hepatic cirrhosis

Exclusion criteria

• Acute flare of hepatitis
• Positive pregnancy test for a female
• Significant acute medical illness in past 2 months
• Use of agents known to significantly affect liver metabolism
• Change in medications to treat a chronic disease in the past 2 months

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 4 patient groups

EFV600mg Participants With Mild Hepatic Impairment

Experimental group

Treatment:

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen

EFV600mg Participants With Moderate Hepatic Impairment

Experimental group

Treatment:

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen

EFV600mg Participants With Severe Hepatic Impairment

Experimental group

Treatment:

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen

EFV600mg Participants With Normal Hepatic Function

Active Comparator group

Treatment:

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen

Drug: efavirenz containing antiretroviral regimen