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NCT00337922 Clinical Trial

Pharmacokinetic Study Of EPZICOM Tablet

HIV Infection Clinical Trial

Official title:
Post-Marketing Clinical Study of EPZICOM Tablet (Lamivudine / Abacavir Sulfate) - Pharmacokinetic Study in HIV-Infected Patients -

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00337922
Other study ID # 104807
Secondary ID
Status Completed
Phase Phase 4
First received June 16, 2006
Last updated October 15, 2008
Start date July 2006

Study information
Verified date October 2008
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 64 Years
Eligibility Inclusion criteria:

- 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.

Exclusion criteria:

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lamivudine / Abacavir Sulfate

Locations
Country Name City State
Japan GSK Investigational Site Nagano
Japan GSK Investigational Site Osaka
Japan GSK Investigational Site Shizuoka
Japan GSK Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Safety (adverse events occurring during the study period)
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