NCT01205243

ZIAGEN® Post-marketing Surveillance

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 671 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Infection, Human Immunodeficiency Virus I

Interventions

Type	Name	Description
DRUG	ZIAGEN®	Basically there is no treatment allocation. Subjects who would be administrated ZIAGEN® at their physician's discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Timeline

• Start date: 2010-11-01
• Primary completion: 2015-02-01
• Completion: 2015-02-05
• First posted: 2010-09-20
• Last updated: 2018-06-19

Locations

1 site across 1 country: South Korea