An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Efficacy of ZIAGEN® Administered in Korean Patients According to the Prescribing Information

ViiV Healthcare1 site in 1 country671 target enrollmentNovember 1, 2010

ConditionsInfection, Human Immunodeficiency Virus I

InterventionsZIAGEN®

DrugsZIAGEN®

Overview

Phase: Not Applicable
Intervention: ZIAGEN®
Conditions: Infection, Human Immunodeficiency Virus I
Sponsor: ViiV Healthcare
Enrollment: 671
Locations: 1
Primary Endpoint: Occurrence of adverse event after ZIAGEN® administration
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGEN® administered in Korean patients according to the prescribing information.

Detailed Description

This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of KFDA for market authorization. ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Registry

clinicaltrials.gov

Start Date

November 1, 2010

End Date

February 5, 2015

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

ViiV Healthcare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

ZIAGEN®

Patients administrated ZIAGEN® at the site

Intervention: ZIAGEN®

Outcomes

Primary Outcomes

Occurrence of adverse event after ZIAGEN® administration

Time Frame: 12month

Secondary Outcomes

Occurrence of unexpected adverse drug reaction after ZIAGEN® administration(12 month)
Occurrence of serious adverse event after ZIAGEN® administration(12month)
efficacy after ZIAGEN® administration(12month)