Phase 1
N=16
Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
HIV Infections · Hepatic Impairment
Bottom Line
View on ClinicalTrials.gov: NCT00162097 ↗Enrolled (actual)
16
Serious AEs
4.8%
Results posted
Aug 2010
Primary outcome: Primary: Maximum Plasma Concentration (Cmax) — 5.303; 8.964; 6.750; 6.515 micrograms (mcg)/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- efavirenz containing antiretroviral regimen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
5.303; 8.964; 6.750; 6.515 | — |
| PRIMARY Minimum Plasma Concentration (Cmin) |
2.599; 4.885; 3.780; 2.405 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve Over the Dosing Interval of 24 Hours (AUC[TAU]) |
83.422; 75.425; 101.912; 93.516 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
1.765; 4.500; 1.000; 3.500 | — |
| SECONDARY Number of Participants Who Died or Experienced Other Serious Adverse Events (SAEs) |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants Who Experienced AEs |
1; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Experienced AEs Leading to Study Drug Discontinuation |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Marked Abnormalities (MAs) in Hematology Measurements |
0; 1; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Serum Chemistry MAs |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Urinalysis MAs |
1; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Identified Electrocardiogram (ECG) Abnormalities |
3; 1; 0; 5 | — |
| SECONDARY Number of Participants With Clinically Meaningful Vital Signs Measures |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Physical Examination Findings at Baseline (Screening and/or Day 1) |
5; 2; 1; 5 | — |
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
Data sourced from ClinicalTrials.gov (NCT00162097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.