At a glance
ClinicalIndex Comparison Record- ✓HIV-1 infection (with or without Hepatitis B or C coinfection)
- ✓On stable efavirenz-containing antiretroviral regimen with NRTIs for at least 1 month
- ✓Hepatic impairment (mild, moderate, or severe) with or without cirrhosis
- ✕Acute hepatitis flare
- ✕Pregnancy (positive pregnancy test)
- ✕Significant acute medical illness in past 2 months
- ✕Current use of agents that significantly affect liver metabolism
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics of Efavirenz During Treatment of HIV-1 Infected Subjects With Hepatic Impairment.
In Brief
A Phase 1 clinical trial evaluating efavirenz containing antiretroviral regimen for HIV Infections and Hepatic Impairment. Completed, enrolled 21 participants across 4 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Capsule or Tablet, Oral, once daily for 2 days
Capsule or Tablet, Oral, once daily for 2 days
Capsule or Tablet, Oral, once daily for 2 days
Capsule or Tablet, Oral, once daily for 2 days