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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162097

Purpose

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.

Condition	Intervention	Phase
HIV Infections Hepatic Impairment	Drug: efavirenz containing antiretroviral regimen	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Official Title:	Pharmacokinetics of Efavirenz During Treatment of HIV-1 Infected Subjects With Hepatic Impairment.

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To assess steady-state PK of efavirenz in HIV-1 infected subjects on stable antiretroviral regimens containing efavirenz, and having selected degrees of hepatic impairment or normal hepatic function. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety of efavirenz in HIV-1 infected subjects, with or without hepatic impairment, on stable antiretroviral regimen containing efavirenz. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	November 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 600 mg	Drug: efavirenz containing antiretroviral regimen Capsule or Tablet, Oral, once daily for 3 days
B: Experimental 600 mg	Drug: efavirenz containing antiretroviral regimen Capsule or Tablet, Oral, once daily for 3 days
C: Experimental 600 mg or reduced dosage	Drug: efavirenz containing antiretroviral regimen Capsule or Tablet, Oral, once daily for 3 days
D: Active Comparator 600 mg	Drug: efavirenz containing antiretroviral regimen Capsule or Tablet, Oral, once daily for 3 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162097

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, Maryland
Johns Hopkins University School Of Medicine	Active, not recruiting
Baltimore, Maryland, United States, 21287
United States, Texas
Uthscsa	Recruiting
San Antonio, Texas, United States, 78229
Contact: Marc Weiner, Site 006 210-617-5300 ext 6060/6381
United States, Virginia
Virginia Commonwealth University Health Systems	Recruiting
Richmond, Virginia, United States, 23298
Contact: Richard Sterling, Site 002 804-828-4060
Italy
Local Institution	Recruiting
Milano, Italy, 20127
Contact: Site 008
Spain
Local Institution	Recruiting
Sevilla, Spain, 41013
Contact: Site 007

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI266-917
Study First Received:	September 9, 2005
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00162097
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
Liver Diseases
Digestive System Diseases

HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009