Pharmacokinetic Study Of EPZICOM Tablet
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection
Intervention: Lamivudine / Abacavir Sulfate (Drug)
Phase: Phase 4
Sponsored by: GlaxoSmithKline
Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
This study was designed to explore the drug levels in the blood in Japanese HIV-infected
patients taking EPZICOM tablet at least for 2 weeks prior to administration of the study
drug. Pharmacokinetics after administration of EPZICOM tablet will be investigated in a
total of 8 subjects.
Official title: Post-Marketing Clinical Study of EPZICOM Tablet (Lamivudine / Abacavir Sulfate) - Pharmacokinetic Study in HIV-Infected Patients -
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The following pharmacokinetic parameters of plasma lamivudine and abacavir Maximum plasma concentration(Cmax), Time to the maximum plasma concentration(tmax), Elimination half-life(t1/2), Area under the plasma concentration-time curve(AUC)
Secondary outcome: Safety (adverse events occurring during the study period)
Minimum age: 20 Years.
Maximum age: 64 Years.
- A Japanese HIV-infected patient who continues to use one EPZICOM tablet in the
morning (00: 00 to 12: 00) at least for 2 weeks prior to administration of the study
- A patient who agrees to abstain from alcohol from 48 hours prior to administration of
the study drug until completion of blood sampling for pharmacokinetic analysis.
- A patient developing AIDS (Patients who developed AIDS in the past but have no
symptoms or findings that may serve as indicators at screening may be eligible for
- A patient with a history of hypersensitivity to the study drug and the ingredients
(lamivudine, abacavir sulfate) of the study drug
Locations and Contacts
GSK Investigational Site, Nagano 384-0301, Japan
GSK Investigational Site, Osaka 540-0006, Japan
GSK Investigational Site, Shizuoka 432-8002, Japan
GSK Investigational Site, Tokyo 162-0052, Japan
Starting date: July 2006
Last updated: October 15, 2008