Post-Marketing Clinical Study of EPZICOM Tablet (Lamivudine / Abacavir Sulfate) -Pharmacokinetic Study in HIV-Infected Patients
Phase 4
- Conditions
- HIV infection
- Registration Number
- JPRN-jRCT1080220286
- Lead Sponsor
- GlaxoSmithKline K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Main inclusion criteria:
- A Japanese HIV-infected patient who continues to use one EPZICOM tablet in the morning 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.
Main exclusion criteria:
- A patient developing AIDS
- A patient with a history of hypersensitivity to the study drug and the ingredients (lamivudine, abacavir sulfate) of the study drug
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is the pharmacokinetic parameters of plasma lamivudine and abacavir
- Secondary Outcome Measures
Name Time Method