Clinical trial NCT00162097: Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
Official title: Pharmacokinetics of Efavirenz During Treatment of HIV-1 Infected Subjects With Hepatic Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Hepatic Impairment
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
measure: Minimum Plasma Concentration (Cmin)
timeFrame: Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
measure: Area Under the Plasma Concentration-time Curve Over the Dosing Interval of 24 Hours (AUC[TAU])
timeFrame: Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
Secondary outcomes:
measure: Number of Participants Who Died or Experienced Other Serious Adverse Events (SAEs)
timeFrame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing). Participants were monitored for SAEs up to 30 days after study discharge.
measure: Number of Participants Who Experienced AEs
timeFrame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).
measure: Number of Participants Who Experienced AEs Leading to Study Drug Discontinuation
timeFrame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).
measure: Number of Participants With Marked Abnormalities (MAs) in Hematology Measurements
timeFrame: Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.
measure: Number of Participants With Serum Chemistry MAs
timeFrame: Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.
measure: Number of Participants With Urinalysis MAs
timeFrame: Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.
measure: Number of Participants With Identified Electrocardiogram (ECG) Abnormalities
timeFrame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)
measure: Number of Participants With Clinically Meaningful Vital Signs Measures
timeFrame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)
measure: Number of Participants With Abnormal Physical Examination Findings at Baseline (Screening and/or Day 1)
timeFrame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School Of Medicine
state: Maryland
city: San Antonio
country: United States
facility: Uthscsa
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Health Systems
state: Virginia
city: Milano
country: Italy
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: