NCT00337922

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
Last Updated

October 16, 2008

Status Verified

October 1, 2008

First QC Date

June 16, 2006

Last Update Submit

October 15, 2008

Conditions

HIV Infection

Keywords

EPZICOMLamivudineAbacavirpharmacokineticsJapanese

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Safety (adverse events occurring during the study period)

Interventions

Lamivudine / Abacavir SulfateDRUG

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 drug.
  • 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.

You may not qualify if:

  • 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 the study.)
  • A patient with a history of hypersensitivity to the study drug and the ingredients (lamivudine, abacavir sulfate) of the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

GSK Investigational Site

Nagano, 384-0301, Japan

Location

GSK Investigational Site

Osaka, 540-0006, Japan

Location

GSK Investigational Site

Shizuoka, 432-8002, Japan

Location

GSK Investigational Site

Tokyo, 162-0052, Japan

Location

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir, lamivudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

July 1, 2006

Last Updated

October 16, 2008

Record last verified: 2008-10

Locations

JP(4)